Cardiovascular Diseases, Coronary Disease, Heart Diseases, Heart Failure, Congestive
Conditions
Brief summary
This study will compare medical therapy with coronary bypass surgery and/or surgical ventricular reconstruction for patients with congestive heart failure and coronary artery disease (CAD).
Detailed description
BACKGROUND: Congestive heart failure afflicts approximately five million Americans and is the leading cause of hospitalization in Americans over the age of 65. Most cases of congestive heart failure are due to CAD. Surprisingly little is known about the relative benefits of medical versus surgical therapy for patients with obstructive coronary disease and congestive heart failure. Randomized studies of medical therapy versus bypass surgery for obstructive coronary disease were conducted in the 1970s and did not include the systematic use of aspirin, arterial conduits, or lipid-lowering medications. In addition, patients with ejection fractions below 35% were specifically excluded from the three large randomized studies of medical therapy versus bypass surgery. While observational data from the 1970s and early 1980s suggest a survival advantage associated with bypass surgery in patients with low ejection fraction and congestive heart failure, biases favoring the referral of the fittest of such patients for bypass surgery may have confounded these comparisons. In addition, medical therapy for congestive heart failure has improved dramatically over the past two decades. Thus, the choice of medical therapy versus bypass surgery for patients with congestive heart failure and obstructive coronary disease is usually decided by guesswork. This study is designed to provide a solid answer. PURPOSE: STICH is a multicenter, international, randomized trial that addresses two specific primary hypotheses in patients with clinical heart failure (HF) and left ventricular (LV) dysfunction who have coronary artery disease amenable to surgical revascularization. The first hypothesis is that restoration of blood flow by means of coronary revascularization recovers chronic LV dysfunction and improves survival, as compared to intensive medical therapy alone. The second hypothesis is that surgical ventricular restoration (SVR) to a more normal LV size improves survival free of subsequent hospitalization for cardiac cause compared to CABG alone. Patients eligible for either medical therapy or CABG, but not eligible for the SVR procedure (Stratum A), will be randomized in equal proportions to medical therapy alone versus CABG plus medical therapy. Patients eligible for all three therapies (Stratum B) will be randomized in equal proportions to medical therapy alone, CABG plus medical therapy, and CABG plus SVR plus medical therapy. Patients whose severity of angina or CAD makes them inappropriate for medical therapy alone (Stratum C) will be randomized in equal proportions to CABG plus medical therapy versus CABG plus SVR plus medical therapy. The overall target was to recruit 1200 patients into Hypothesis One and 1,000 patients into Hypothesis Two. Secondary endpoints include the role of myocardial viability, morbidity, economics, and quality of life. Core laboratories for quality of life/economics, cardiac magnetic resonance (CMR), echocardiography (ECHO), neurohormonal/cytokine/genetic (NCG), and radionuclide (RN) studies ensure consistent testing practices and standardization of data necessary to identify eligible patients and to address specific questions related to the stated hypotheses. IMPORTANCE OF RESEARCH: The most common cause of HF is no longer hypertension or valvular heart disease as it was in previous decades, but rather CAD. HF is a common worldwide disease and CAD is a frequent cause of HF initiation and progression. HF is responsible for approximately 1 million hospitalizations and 300,000 fatalities annually. The prevalence of HF is increasing, largely due to enhanced survival following acute myocardial infarction and other manifestations of CAD. No randomized trial has ever compared directly the long-term benefits of surgical, medical, or combined surgical and medical treatment of patients with ischemic HF. The STICH trial is the first trial to compare the long term benefits of surgical and medical treatment in patients with ischemic HF. Although modern medical therapy for HF modestly improves quality of life, a more aggressive approach with the surgical therapies being studied in the STICH trial may produce even greater improvements. The common clinical practice of not offering CABG to patients with LV dysfunction in regions found to be nonviable on noninvasive studies is not evidence-based. Since only those patients for whom intensive medical therapy is the only reasonable therapeutic alternative are excluded from this study, the results of the STICH trial should be applicable to most patients with CAD, HF, and systolic LV dysfunction. The results of the STICH trial will also establish whether measurements of neurohormonal and cytokine levels and genetic profiling are useful for directing patient management decisions, for monitoring the effectiveness of therapy, and for refining the optimal approach for selecting the treatment strategy most likely to be effective for the many of these patients.
Interventions
PROCEDURECABG surgery plus MED
CABG plus standard medication management for Coronary Artery Disease
DRUGActive Medication Alone
Standard medication for coronary artery disease and heart failure management.
PROCEDURECABG plus MED and SVR
H02: the experimental arm receives active medical therapy and CABG and surgical ventricular restoration whereas the control group receives active medical therapy and CABG; for H01: the experimental arm receives active medical therapy and CABG whereas the control group receives active medical therapy alone
Sponsors
National Heart, Lung, and Blood Institute (NHLBI)
Duke University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
* LV less than 35%, as defined by echocardiogram, left ventriculogram, CMR, or gated single photon emission computed tomography (SPECT) studies * Coronary anatomy suitable for revascularization
Exclusion criteria
* Failure to provide informed consent. * Aortic valvular heart disease clearly indicating the need for aortic valve repair or replacement. * Cardiogenic shock (within 72 hours of randomization), as defined by the need for intraaortic balloon support or the requirement for intravenous inotropic support. * Plan for percutaneous intervention of CAD. * Recent acute MI judged to be an important cause of left ventricular dysfunction. * History of more than 1 prior coronary bypass operation. * Noncardiac illness with a life expectancy of less than 3 years. * Noncardiac illness imposing substantial operative mortality. * Conditions/circumstances likely to lead to poor treatment adherence (eg, history of poor compliance, alcohol or drug dependency, psychiatric illness, no fixed abode). * Previous heart, kidney, liver, or lung transplantation. * Current participation in another clinical trial in which a patient is taking an investigational drug or receiving an investigational medical device. MED Therapy Eligibility Criteria * Absence of left main CAD as defined by an intraluminal stenosis of 50% or greater. * Absence of CCS III angina or greater (angina markedly limiting ordinary activity). SVR Eligibility Criterion • Dominant akinesia or dyskinesia of the anterior left ventricular wall amenable to SVR.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| H01: All Cause Mortality | 5 years post randomization |
| H02: All-cause Mortality or Cardiovascular Hospitalization | 5 years post randomization |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| H02: Cardiac Procedure: Implantable Cardioverter Defibrillator (ICD) | 5 years post randomization | — |
| H01: Cardiovascular Mortality (Defined as Sudden Death or Death Attributed to Recurrent MI, HF, a Cardiovascular Procedure, Stroke, or Other Cardiovascular Etiology). | 10 years post randomization | — |
| H01: Mortality or Cardiovascular Hospitalization | up to 5 years post randomization | — |
| H02: All-cause Mortality | up to 5 years | — |
| H01: All-cause Mortality Within 30 Days After Randomization | 30 days post randomization | — |
| H02: All-cause Mortality Within 30 Days After Randomization | 30 days post randomization | — |
| H01: All-cause Mortality or Heart-failure Hospitalization | 5 years post randomization | — |
| H02: All-cause Mortality or Heart-failure Hospitalization | 5 years post randomization | — |
| H01: Heart Failure Hospitalization | 5 years post randomization | — |
| H02: Heart Failure Hospitalization | 5 years post randomization | — |
| H01: Cardiac Procedure: Heart Transplant | 5 years post randomization | — |
| H02: Cardiac Procedure: Heart Transplant | 5 years post randomization | — |
| H01: Cardiac Procedure: Left Ventricular Assist Device (LVAD) | 5 years post randomization | — |
| H02: Cardiac Procedure: Left Ventricular Assist Device (LVAD) | 5 years post randomization | — |
| H01: Cardiac Procedure: Implantable Cardioverter Defibrillator (ICD) | 5 years post randomization | — |
| H01: Stroke | 5 years post randomization | — |
| H02: Stroke | 5 years post randomization | — |
| H01: All-cause Mortality or Revascularization (CABG or PCI) | 5 years post randomization | CABG = coronary artery bypass grafting. For patients randomized to CABG or CABG +SVR group, this represents the repeat CABG received during follow-up. PCI = Percutaneous Coronary Intervention. |
| H02: All-cause Mortality or Revascularization (CABG or PCI) | 5 years post randomization | CABG = coronary artery bypass grafting. For patients randomized to CABG or CABG +SVR group, this represents the repeat CABG received during follow-up. PCI = Percutaneous Coronary Intervention. |
| H01: All-cause Mortality, Heart Transplant or LVAD | 5 years post randomization | LVAD=Left Ventricular Assist Device |
| H02: All-cause Mortality, Heart Transplant or LVAD | 5 years post randomization | — |
| H01: All-cause (Unplanned and Elective) Hospitalization | 5 years post randomization | — |
| H02: All-cause (Unplanned and Elective) Hospitalization | 5 years post randomization | — |
| H01: 6 Minute Walk Distance | From randomization to 24 month follow-up | — |
| H02: 6 Minute Walk Distance | From randomization to 24 month follow-up | — |
| H01: Exercise Duration | From randomization to 24 months follow-up | Record the total duration of exercise in minutes and seconds for patients performing the modified Bruce exercise treadmill test |
| H02: Exercise Duration | From randomization to 24 months follow-up | Record the total duration of exercise in minutes and seconds for patients performing the modified Bruce exercise treadmill test |
| H01: LVEF by ECHO Core Lab During Follow-up | From randomization to 24 months follow-up | Left ventricular ejection fraction (LVEF) measured by Echocardiography (ECHO) core lab |
| H02: LVEF by ECHO Core Lab During Follow-up | From randomization to 24 months follow-up | Left ventricular ejection fraction (LVEF) measured by Echocardiography (ECHO) core lab |
| H01: LVEF by RN Core Lab During Follow-up | From randomization to 24 months follow-up | Left ventricular ejection fraction (LVEF) measured by radionuclide (RN) core lab. |
| H02: LVEF by RN Core Lab During Follow-up | From randomization to 24 months follow-up | Left ventricular ejection fraction (LVEF) measured by radionuclide (RN) core lab. |
| H01: LVEF by CMR Core Lab During Follow-up | From randomization to 24 months follow-up | Left ventricular ejection fraction (LVEF) measured by cardiovascular magnetic resonance (CMR) core lab. |
| H02: LVEF by CMR Core Lab During Follow-up | From randomization to 24 months follow-up | Left ventricular ejection fraction (LVEF) measured by cardiovascular magnetic resonance (CMR) core lab. |
| H01: B-type Natriuretic Peptide (BNP) | From randomization to 24 months follow-up | B-type natriuretic peptide (BNP) by Neurohormonal/cytokine/genetic (NCG) core lab during follow-up |
| H02: B-type Natriuretic Peptide (BNP) | From randomization to 24 months follow-up | B-type natriuretic peptide (BNP) by Neurohormonal/cytokine/genetic (NCG) core lab during follow-up |
| H01: SF-36 Mental Health Subscale | From enrollment to 3-year follow-up | Short Form 36 Health Status Questionnaire (SF-36) Mental Health Subscale: These 5 items assess anxiety, depression, emotional control, and psychological well-being. Response choices range from All of the time (1) to None of the time (6). Item values are summed and then transformed to a 0-100 scale where higher scores indicate better mental health. (Final scores are normalized to a mean of 50 and standard deviation of 10.) |
| H02: SF-36 Mental Health Subscale | From enrollment to 3-year follow-up | These 5 items assess anxiety, depression, emotional control, and psychological well-being. Response choices range from All of the time (1) to None of the time (6). Item values are summed and then transformed to a 0-100 scale where higher scores indicate better mental health. (Final scores are normalized to a mean of 50 and standard deviation of 10.) |
| H01:SF-36 Role Physical Subscale | From enrollment to 3-year follow-up | These 4 items assess limitations and difficulty performing work or other usual activities as a result of one's physical health. Response choices are either Yes (1) or No (2). Item values are summed and then transformed to a 0-100 scale where higher scores indicate better outcomes. (Final scores are normalized to a mean of 50 and standard deviation of 10.) |
| H02: SF-36 Role Physical Subscale | From enrollment to 3-year follow-up | These 4 items assess limitations and difficulty performing work or other usual activities as a result of one's physical health. Response choices are either Yes (1) or No (2). Item values are summed and then transformed to a 0-100 scale where higher scores indicate better outcomes. (Final scores are normalized to a mean of 50 and standard deviation of 10.) |
| H01:SF-36 Role Emotional Subscale | From enrollment to 3-year follow-up | These 3 items assess limitations and difficulty performing work or other usual activities as a result of any emotional problems (such as feeling depressed or anxious). Response choices are either Yes (1) or No (2). Item values are summed and then transformed to a 0-100 scale where higher scores indicate better outcomes. (Final scores are normalized to a mean of 50 and standard deviation of 10.) |
| H02: SF-36 Role Emotional Subscale | From enrollment to 3-year follow-up | These 3 items assess limitations and difficulty performing work or other usual activities as a result of any emotional problems (such as feeling depressed or anxious). Response choices are either Yes (1) or No (2). Item values are summed and then transformed to a 0-100 scale where higher scores indicate better outcomes. (Final scores are normalized to a mean of 50 and standard deviation of 10.) |
| H01:SF-36 Social Functioning Subscale | From enrollment to 3-year follow-up | These 2 items assess the limitations on social activities with others. Response choices range from Extremely or All of the time (1) to Not at all or None of the time (5). Item values are summed and then transformed to a 0-100 scale where higher scores indicate better social functioning. (Final scores are normalized to a mean of 50 and standard deviation of 10.) |
| H02: SF-36 Social Functioning Subscale | From enrollment to 3-year follow-up | These 2 items assess the limitations on social activities with others. Response choices range from Extremely or All of the time (1) to Not at all or None of the time (5). Item values are summed and then transformed to a 0-100 scale where higher scores indicate better social functioning. (Final scores are normalized to a mean of 50 and standard deviation of 10.) |
| H01:SF-36 Vitality Subscale | From enrollment to 3-year follow-up | These 4 items assess energy level and fatigue. Response choices range from All of the time (1) to None of the time (6). Item values are summed and then transformed to a 0-100 scale where higher scores indicate better vitality. (Final scores are normalized to a mean of 50 and standard deviation of 10.) |
| H02: SF-36 Vitality Subscale | From enrollment to 3-year follow-up | These 4 items assess energy level and fatigue. Response choices range from All of the time (1) to None of the time (6). Item values are summed and then transformed to a 0-100 scale where higher scores indicate better vitality. (Final scores are normalized to a mean of 50 and standard deviation of 10.) |
| H01:SF-12 Physical Component Summary (PCS) Scale | From enrollment to 3-year follow-up | Twelve items that reflect both physical and mental health are selected from the SF-36 subscales and combined according to an algebraic formula using published weights and constants: (a) First, the items are coded so that a higher value indicates better health; (b) then indicator variables (1/0) are created for the item response choice categories; (c) next, the 35 indicator variables are weighted using physical regression weights from the general US population and summed to produce the PCS-12 score; and (d) finally, a normalized score (with a mean of 50 and standard deviation of 10) is obtained by adding the physical constant from the scoring table to the sum of the 35 products. |
| H02: SF-12 Physical Component Summary (PCS) Scale | From enrollment to 3-year follow-up | Twelve items that reflect both physical and mental health are selected from the SF-36 subscales and combined according to an algebraic formula using published weights and constants: (a) First, the items are coded so that a higher value indicates better health; (b) then indicator variables (1/0) are created for the item response choice categories; (c) next, the 35 indicator variables are weighted using physical regression weights from the general US population and summed to produce the PCS-12 score; and (d) finally, a normalized score (with a mean of 50 and standard deviation of 10) is obtained by adding the physical constant from the scoring table to the sum of the 35 products. |
| H01: SF-12 Mental Component Summary (MCS) Scale | From enrollment to 3-year follow-up | Twelve items that reflect both physical and mental health are selected from the SF-36 subscales and combined according to an algebraic formula using published weights and constants: (a) First, the items are coded so that a higher value indicates better health; (b) then indicator variables (1/0) are created for the item response choice categories; (c) next, the 35 indicator variables are weighted using mental regression weights from the general US population and summed to produce the MCS-12 score; and (d) finally, a normalized score (with a mean of 50 and standard deviation of 10) is obtained by adding the mental constant from the scoring table to the sum of the 35 products. |
| H02: SF-12 Mental Component Summary (MCS) Scale | From enrollment to 3-year follow-up | Twelve items that reflect both physical and mental health are selected from the SF-36 subscales and combined according to an algebraic formula using published weights and constants: (a) First, the items are coded so that a higher value indicates better health; (b) then indicator variables (1/0) are created for the item response choice categories; (c) next, the 35 indicator variables are weighted using mental regression weights from the general US population and summed to produce the MCS-12 score; and (d) finally, a normalized score (with a mean of 50 and standard deviation of 10) is obtained by adding the mental constant from the scoring table to the sum of the 35 products. |
| H01: KCCQ Physical Limitation Scale | From enrollment to 3-year follow-up | Kansas City Cardiomyopathy Questionnaire (KCCQ)Physical Limitation Scale: These 6 items assess ability to perform various activities of daily living. Response choices range from Extremely limited (1) to Not at all limited (5). Mean scores are transformed to a 0-100 scale with high scores representing better outcomes. . |
| H02: KCCQ Physical Limitation Scale | From enrollment to 3-year follow-up | These 6 items assess ability to perform various activities of daily living. Response choices range from Extremely limited (1) to Not at all limited (5). Mean scores are transformed to a 0-100 scale with high scores representing better outcomes. |
| H01: KCCQ Symptom Stability | From enrollment to 3-year follow-up | This item assesses changes in shortness of breath or fatigue over the past 2 weeks. Response choices range from Much worse (1) to Much better (5). Item score is transformed to a 0-100 scale with a high score representing a better outcome. . |
| H02: KCCQ Symptom Stability | From enrollment to 3-year follow-up | This item assesses changes in shortness of breath or fatigue over the past 2 weeks. Response choices range from Much worse (1) to Much better (5). Item score is transformed to a 0-100 scale with a high score representing a better outcome. |
| H01: KCCQ Symptom Frequency | From enrollment to 3-year follow-up | These 4 items assess how many times the patient has been bothered by shortness of breath, fatigue, and ankle swelling over the past 2 weeks. Response choices vary, but they range from Every morning or Every night or All of the time (1) to Never over the past 2 weeks (either 5 or 7). Mean scores are transformed to a 0-100 scale with high scores representing better outcomes. . |
| H02: KCCQ Symptom Frequency | From enrollment to 3-year follow-up | These 4 items assess how many times the patient has been bothered by shortness of breath, fatigue, and ankle swelling over the past 2 weeks. Response choices vary, but they range from Every morning or Every night or All of the time (1) to Never over the past 2 weeks (either 5 or 7). Mean scores are transformed to a 0-100 scale with high scores representing better outcomes. |
| H01: KCCQ Symptom Burden | From enrollment to 3-year follow-up | These 3 items assess how much the patient has been bothered by shortness of breath, fatigue, and ankle swelling over the past 2 weeks. Response choices range from extremely bothersome (1) to Not at all bothersome (5). Mean scores are transformed to a 0-100 scale with high scores representing better outcomes. |
| H02: KCCQ Symptom Burden | From enrollment to 3-year follow-up | These 3 items assess how much the patient has been bothered by shortness of breath, fatigue, and ankle swelling over the past 2 weeks. Response choices range from extremely bothersome (1) to Not at all bothersome (5). Mean scores are transformed to a 0-100 scale with high scores representing better outcomes. |
| H01: KCCQ Total Symptoms | From enrollment to 3-year follow-up | This score represents the mean of the Symptom Frequency and Symptom Burden scores. Mean scores are transformed to a 0-100 scale with high scores representing better outcomes. . |
| H02: KCCQ Total Symptoms | From enrollment to 3-year follow-up | This score represents the mean of the Symptom Frequency and Symptom Burden scores. Mean scores are transformed to a 0-100 scale with high scores representing better outcomes. |
| H01: KCCQ Quality-of-Life Scale | From enrollment to 3-year follow-up | These 3 items assess the effect of heart failure on the patient's enjoyment of life. Response choices range from 1 (worst state) to 5 (best state). Mean scores are transformed to a 0-100 scale with high scores representing better outcomes. . |
| H02: KCCQ Quality-of-Life Scale | From enrollment to 3-year follow-up | These 3 items assess the effect of heart failure on the patient's enjoyment of life. Response choices range from 1 (worst state) to 5 (best state). Mean scores are transformed to a 0-100 scale with high scores representing better outcomes. |
| H01: KCCQ Social Limitation | From enrollment to 3-year follow-up | These 4 items assess how much heart failure has affected the patient's lifestyle. Response choices range from Severely limited (1) to Did not limit at all (5). Mean scores are transformed to a 0-100 scale with high scores representing better outcomes. . |
| H02: KCCQ Social Limitation | From enrollment to 3-year follow-up | These 4 items assess how much heart failure has affected the patient's lifestyle. Response choices range from Severely limited (1) to Did not limit at all (5). Mean scores are transformed to a 0-100 scale with high scores representing better outcomes. |
| H01: KCCQ Clinical Summary Score | From enrollment to 3-year follow-up | This score represents the mean of the Physical Limitation and Total Symptom scores. Mean scores are transformed to a 0-100 scale with high scores representing better outcomes. . |
| H02: KCCQ Clinical Summary Score | From enrollment to 3-year follow-up | This score represents the mean of the Physical Limitation and Total Symptom scores. Mean scores are transformed to a 0-100 scale with high scores representing better outcomes. |
| H01: KCCQ Overall Summary Score | From enrollment to 3-year follow-up | This score represents the mean of these 4 scores: Physical Limitation, Total Symptom, Quality of Life, and Social Limitation. Mean scores are transformed to a 0-100 scale with high scores representing better outcomes. . |
| H02: KCCQ Overall Summary Score | From enrollment to 3-year follow-up | This score represents the mean of these 4 scores: Physical Limitation, Total Symptom, Quality of Life, and Social Limitation. Mean scores are transformed to a 0-100 scale with high scores representing better outcomes. |
| H01: Seattle Angina Questionnaire (SAQ) Anginal Frequency Subscale | From enrollment to 3-year follow-up | These 2 items assess the frequency of chest pain over the last 4 weeks. Response choices range from 4 or more times a day (1) to None (6). The mean response is transformed to a 0-100 scale where higher scores reflect less frequent angina. . |
| H02: Seattle Angina Questionnaire (SAQ) Anginal Frequency Subscale | From enrollment to 3-year follow-up | These 2 items assess the frequency of chest pain over the last 4 weeks. Response choices range from 4 or more times a day (1) to None (6). The mean response is transformed to a 0-100 scale where higher scores reflect less frequent angina. |
| H01: Seattle Angina Questionnaire (SAQ) Anginal Stability Subscale | From enrollment to 3-year follow-up | This item assesses the change in chest pain over the last 4 weeks. Response choices range from Much more often (1) to None (6). The mean response is transformed to a 0-100 scale where 50 represents no change and a higher score indicates less angina. . |
| H02: Seattle Angina Questionnaire (SAQ) Anginal Stability Subscale | From enrollment to 3-year follow-up | This item assesses the change in chest pain over the last 4 weeks. Response choices range from Much more often (1) to None (6). The mean response is transformed to a 0-100 scale where 50 represents no change and a higher score indicates less angina. |
| H01:Seattle Angina Questionnaire (SAQ) Quality-of-Life Subscale | From enrollment to 3-year follow-up | These 3 items measure the patient's general satisfaction with life. Response choices range from 1 (least enjoyment) to 5 (high satisfaction). The mean score is transformed to a 0-100 scale where higher scores reflect better outcomes. . |
| H02: Seattle Angina Questionnaire (SAQ) Quality-of-Life Subscale | From enrollment to 3-year follow-up | These 3 items measure the patient's general satisfaction with life. Response choices range from 1 (least enjoyment) to 5 (high satisfaction). The mean score is transformed to a 0-100 scale where higher scores reflect better outcomes. |
| H01: EQ-5D Visual Analog Scale | From enrollment to 3-year follow-up | Euro QoL 5 Dimensions Quality of Life Instrument (EQ-5D): This 0-100 scale records the patient's self-rated health on a vertical scale where 0 = worst imaginable health and 100 = perfect health. . |
| H02: EQ-5D Visual Analog Scale | From enrollment to 3-year follow-up | This 0-100 scale records the patient's self-rated health on a vertical scale where 0 = worst imaginable health and 100 = perfect health. |
| H01: EQ-5D Health Status Index Score | From enrollment to 3-year follow-up | This 5-item scale describes a patient's health in terms of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Choices for each dimension are No problems (1), Moderate problems (2), or Extreme problems (3). A scoring algorithm with utility weights is then applied to these 5 items to generate index scores ranging from -0.11 (i.e., 33333) to 1.0 (i.e., 11111) on a scale where 0.0 = death and 1.0 = perfect health. These scores were multiplied by 100 to produce a scale from -11 to 100 that more closely resembles the Visual Analog Scale. . |
| H02: EQ-5D Health Status Index Score | From enrollment to 3-year follow-up | This 5-item scale describes a patient's health in terms of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Choices for each dimension are No problems (1), Moderate problems (2), or Extreme problems (3). A scoring algorithm with utility weights is then applied to these 5 items to generate index scores ranging from -0.11 (i.e., 33333) to 1.0 (i.e., 11111) on a scale where 0.0 = death and 1.0 = perfect health. (These scores can be multiplied by 100 to produce a scale from -11 to 100 that more closely resembles the Visual Analog Scale.) |
| H01: Percentage of Patients With a Score of >= 16 on the Center for Epidemiological Studies Depression (CES-D) Scale | From enrollment to 3-year follow-up | These 20 items assess depressive symptomatology, and responses choices range from Rarely or none of the time (0) to Most or all of the time (3). Scale scores can therefore range from 0 to 60, although scores greater than or equal to 16 are considered high. . |
| H02: Percentage of Patients With a Score of >= 16 on the Center for Epidemiological Studies Depression (CES-D) Scale | From enrollment to 3-year follow-up | These 20 items assess depressive symptomatology, and responses choices range from Rarely or none of the time (0) to Most or all of the time (3). Scale scores can therefore range from 0 to 60, although scores greater than or equal to 16 are considered high. |
| H01: Cardiac Self-Efficacy (CSE) Maintain Functioning Subscale | From enrollment to 3-year follow-up | These 5 items assess patients' ability to maintain their usual social, family, and physical activities. Response choices range from Not at all confident (1) to Completely confident (5). The mean score is transformed to a 0-100 scale where higher scores reflect more confidence. . |
| H02: Cardiac Self-Efficacy (CSE) Maintain Functioning Subscale | From enrollment to 3-year follow-up | These 5 items assess patients' ability to maintain their usual social, family, and physical activities. Response choices range from Not at all confident (1) to Completely confident (5). The mean score is transformed to a 0-100 scale where higher scores reflect more confidence. |
| H01: Cardiac Self-Efficacy (CSE) Control Symptoms Subscale | From enrollment to 3-year follow-up | These 8 items assess patients' ability to control symptoms such as chest pain and breathlessness by taking their medications and adjusting their activity levels. Response choices range from Not at all confident (1) to Completely confident (5). The mean score is transformed to a 0-100 scale where higher scores reflect more confidence. . |
| H02: Cardiac Self-Efficacy (CSE) Control Symptoms Subscale | From enrollment to 3-year follow-up | These 8 items assess patients' ability to control symptoms such as chest pain and breathlessness by taking their medications and adjusting their activity levels. Response choices range from Not at all confident (1) to Completely confident (5). The mean score is transformed to a 0-100 scale where higher scores reflect more confidence. |
| H01: General Health Rating Scale | From enrollment to 3-year follow-up | This single item asks patients to describe their health status over the past month on a scale from 0 to 100, where 0 = death and 100 = excellent health. . |
| H02: General Health Rating Scale | From enrollment to 3-year follow-up | This single item asks patients to describe their health status over the past month on a scale from 0 to 100, where 0 = death and 100 = excellent health. |
| H01: Cost of Care | index hospital admission | Hospital costs and physician fees for US patients |
| H02: Cost of Care | index hospital admission | Hospital costs and physician fees for US patients |
Countries
United States
Participant flow
Recruitment details
Pts were assigned to 1 of 3 strata before randomization. All pts in stratum C and some pts in stratum B were randomly assigned to med therapy + CABG or med therapy + CABG + SVR (Hypothesis 2 component of the trial-HO2). 76 of stratum B pts who were randomized to med therapy + CABG group belong to both H01 and H02.
Pre-assignment details
Stratum A: eligible for med. therapy alone or med therapy + CABG; Stratum C: eligible for med therapy + CABG or med therapy + CABG + SVR; Stratum B: eligible for all 3 treatment options. All pts in stratum A and some of the pts in stratum B were randomized to either med therapy alone or med therapy + CABG (Hypothesis 1 of the STICH trial--H01).
Participants by arm
| Arm | Count |
|---|---|
| H01: Medication 50% of H01 patients were randomized to this medical therapy alone arm. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm. | 602 |
| H01: Medication + CABG 50% of H01 patients were randomized to medical therapy plus CABG arm. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm. This group does not include those 76 patients who belong to both H01 and H02. | 534 |
| H01+H02: Medication + CABG This group includes those 76 patients who belong to both H01 and H02. These patients were randomized to medical therapy plus CABG arm. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm. | 76 |
| H02: Medication+CABG 50% of H02 patients were randomized to this medical therapy plus CABG arm. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm. This group does not include those 76 patients who belong to both H01 and H02. | 423 |
| H02: Medication+CABG+SVR 50% of H02 patients were randomized to this medical therapy plus CABG plus SVR arm. In addition to the guideline-recommended medications, both the coronary artery bypass graft (CABG) surgery and the surgical ventricular reconstruction (SVR) were to be performed for patients randomized to this treatment arm. | 501 |
| Total | 2,136 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| 10 Year Follow up | Lost to Follow-up | 12 | 10 | 3 | 0 | 0 |
| 5 Year Follow up | Lost to Follow-up | 2 | 2 | 1 | 7 | 3 |
Baseline characteristics
| Characteristic | H01: Medication | H01: Medication + CABG | H01+H02: Medication + CABG | H02: Medication+CABG | H02: Medication+CABG+SVR | Total |
|---|---|---|---|---|---|---|
| Age, Continuous | 59 years | 60 years | 61 years | 62 years | 62 years | 60 years |
| Sex: Female, Male Female | 75 Participants | 64 Participants | 9 Participants | 69 Participants | 69 Participants | 286 Participants |
| Sex: Female, Male Male | 527 Participants | 470 Participants | 67 Participants | 354 Participants | 432 Participants | 1850 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 84 / 602 | 85 / 534 | 9 / 76 | 31 / 423 | 53 / 501 |
Outcome results
Primary
H01: All Cause Mortality
Time frame: 5 years post randomization
Population: The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| H01: Medication | H01: All Cause Mortality | 244 participants |
| H02: Medication+CABG+SVR | H01: All Cause Mortality | 218 participants |
p-value: 0.1295% CI: [0.72, 1.04]Log Rank
Primary
H01: All Cause Mortality
Time frame: 10 years post randomization
Population: The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| H01: Medication | H01: All Cause Mortality | 398 participants |
| H02: Medication+CABG+SVR | H01: All Cause Mortality | 359 participants |
p-value: 0.0295% CI: [0.73, 0.97]Log Rank
Primary
H02: All-cause Mortality or Cardiovascular Hospitalization
Time frame: 5 years post randomization
Population: The Total H02: Medication + CABG group includes the H02: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| H01: Medication | H02: All-cause Mortality or Cardiovascular Hospitalization | 289 participants |
| H02: Medication+CABG+SVR | H02: All-cause Mortality or Cardiovascular Hospitalization | 292 participants |
p-value: 0.995% CI: [0.84, 1.17]Log Rank
Secondary
H01: 6 Minute Walk Distance
Time frame: From randomization to 24 month follow-up
Population: Only patients with 6-minute walk distance data at baseline, 4 months or 24 months were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| H01: Medication | H01: 6 Minute Walk Distance | Changed from baseline to 4 months | 28.2 meters | Standard Deviation 102.44 |
| H01: Medication | H01: 6 Minute Walk Distance | 4 month | 364.25 meters | Standard Deviation 111.24 |
| H01: Medication | H01: 6 Minute Walk Distance | 24 month | 381.55 meters | Standard Deviation 120.86 |
| H01: Medication | H01: 6 Minute Walk Distance | Change from baseline to 24 Months | 34.11 meters | Standard Deviation 112.9 |
| H01: Medication | H01: 6 Minute Walk Distance | Baseline | 333.97 meters | Standard Deviation 117.76 |
| H02: Medication+CABG+SVR | H01: 6 Minute Walk Distance | Change from baseline to 24 Months | 31.18 meters | Standard Deviation 128.99 |
| H02: Medication+CABG+SVR | H01: 6 Minute Walk Distance | Baseline | 333.04 meters | Standard Deviation 117.06 |
| H02: Medication+CABG+SVR | H01: 6 Minute Walk Distance | 4 month | 376.46 meters | Standard Deviation 118.87 |
| H02: Medication+CABG+SVR | H01: 6 Minute Walk Distance | Changed from baseline to 4 months | 37.76 meters | Standard Deviation 108.93 |
| H02: Medication+CABG+SVR | H01: 6 Minute Walk Distance | 24 month | 377.84 meters | Standard Deviation 122.62 |
Secondary
H01: All-cause Mortality, Heart Transplant or LVAD
LVAD=Left Ventricular Assist Device
Time frame: 5 years post randomization
Population: The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| H01: Medication | H01: All-cause Mortality, Heart Transplant or LVAD | 245 participants |
| H02: Medication+CABG+SVR | H01: All-cause Mortality, Heart Transplant or LVAD | 218 participants |
p-value: 0.10895% CI: [0.72, 1.03]Log Rank
Secondary
H01: All-cause Mortality, Heart Transplant or LVAD
LVAD=Left Ventricular Assist Device
Time frame: 10 years post randomization
Population: The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| H01: Medication | H01: All-cause Mortality, Heart Transplant or LVAD | 400 participants |
| H02: Medication+CABG+SVR | H01: All-cause Mortality, Heart Transplant or LVAD | 361 participants |
p-value: 0.01895% CI: [0.73, 0.97]Log Rank
Secondary
H01: All-cause Mortality or Heart-failure Hospitalization
Time frame: 10 years post randomization
Population: The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| H01: Medication | H01: All-cause Mortality or Heart-failure Hospitalization | 450 participants |
| H02: Medication+CABG+SVR | H01: All-cause Mortality or Heart-failure Hospitalization | 404 participants |
p-value: 0.00295% CI: [0.71, 0.93]Log Rank
Secondary
H01: All-cause Mortality or Heart-failure Hospitalization
Time frame: 5 years post randomization
Population: The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| H01: Medication | H01: All-cause Mortality or Heart-failure Hospitalization | 324 participants |
| H02: Medication+CABG+SVR | H01: All-cause Mortality or Heart-failure Hospitalization | 290 participants |
p-value: 0.0395% CI: [0.71, 0.98]Log Rank
Secondary
H01: All-cause Mortality or Revascularization (CABG or PCI)
CABG = coronary artery bypass grafting. For patients randomized to CABG or CABG +SVR group, this represents the repeat CABG received during follow-up. PCI = Percutaneous Coronary Intervention.
Time frame: 10 years post randomization
Population: The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| H01: Medication | H01: All-cause Mortality or Revascularization (CABG or PCI) | 478 participants |
| H02: Medication+CABG+SVR | H01: All-cause Mortality or Revascularization (CABG or PCI) | 388 participants |
p-value: <0.00195% CI: [0.55, 0.73]Log Rank
Secondary
H01: All-cause Mortality or Revascularization (CABG or PCI)
CABG = coronary artery bypass grafting. For patients randomized to CABG or CABG +SVR group, this represents the repeat CABG received during follow-up. PCI = Percutaneous Coronary Intervention.
Time frame: 5 years post randomization
Population: The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| H01: Medication | H01: All-cause Mortality or Revascularization (CABG or PCI) | 333 participants |
| H02: Medication+CABG+SVR | H01: All-cause Mortality or Revascularization (CABG or PCI) | 237 participants |
p-value: <0.00195% CI: [0.51, 0.71]Log Rank
Secondary
H01: All-cause Mortality Within 30 Days After Randomization
Time frame: 30 days post randomization
Population: The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| H01: Medication | H01: All-cause Mortality Within 30 Days After Randomization | 7 participants |
| H02: Medication+CABG+SVR | H01: All-cause Mortality Within 30 Days After Randomization | 22 participants |
p-value: 0.00895% CI: [1.35, 7.52]Regression, Logistic
Secondary
H01: All-cause (Unplanned and Elective) Hospitalization
Time frame: 5 years post randomization
Population: The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| H01: Medication | H01: All-cause (Unplanned and Elective) Hospitalization | 340 participants |
| H02: Medication+CABG+SVR | H01: All-cause (Unplanned and Elective) Hospitalization | 290 participants |
Secondary
H01: All-cause (Unplanned and Elective) Hospitalization
Time frame: 10 years post randomization
Population: The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| H01: Medication | H01: All-cause (Unplanned and Elective) Hospitalization | 383 participants |
| H02: Medication+CABG+SVR | H01: All-cause (Unplanned and Elective) Hospitalization | 349 participants |
Secondary
H01: B-type Natriuretic Peptide (BNP)
B-type natriuretic peptide (BNP) by Neurohormonal/cytokine/genetic (NCG) core lab during follow-up
Time frame: From randomization to 24 months follow-up
Population: Only patients with BNP data at baseline or 4 months were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| H01: Medication | H01: B-type Natriuretic Peptide (BNP) | Baseline | 497.29 pg/mL | Standard Deviation 627.49 |
| H01: Medication | H01: B-type Natriuretic Peptide (BNP) | 4 month | 408.69 pg/mL | Standard Deviation 413.27 |
| H01: Medication | H01: B-type Natriuretic Peptide (BNP) | Changed from baseline to 4 months | -20.65 pg/mL | Standard Deviation 405.44 |
| H02: Medication+CABG+SVR | H01: B-type Natriuretic Peptide (BNP) | Baseline | 478.73 pg/mL | Standard Deviation 521.11 |
| H02: Medication+CABG+SVR | H01: B-type Natriuretic Peptide (BNP) | 4 month | 484.39 pg/mL | Standard Deviation 554.42 |
| H02: Medication+CABG+SVR | H01: B-type Natriuretic Peptide (BNP) | Changed from baseline to 4 months | 33.37 pg/mL | Standard Deviation 566.62 |
Secondary
H01: Cardiac Procedure: Heart Transplant
Time frame: 10 years post randomization
Population: The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| H01: Medication | H01: Cardiac Procedure: Heart Transplant | 4 participants |
| H02: Medication+CABG+SVR | H01: Cardiac Procedure: Heart Transplant | 1 participants |
Secondary
H01: Cardiac Procedure: Heart Transplant
Time frame: 5 years post randomization
Population: The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| H01: Medication | H01: Cardiac Procedure: Heart Transplant | 3 participants |
| H02: Medication+CABG+SVR | H01: Cardiac Procedure: Heart Transplant | 0 participants |
Secondary
H01: Cardiac Procedure: Implantable Cardioverter Defibrillator (ICD)
Time frame: 10 years post randomization
Population: The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| H01: Medication | H01: Cardiac Procedure: Implantable Cardioverter Defibrillator (ICD) | 118 participants |
| H02: Medication+CABG+SVR | H01: Cardiac Procedure: Implantable Cardioverter Defibrillator (ICD) | 105 participants |
Secondary
H01: Cardiac Procedure: Implantable Cardioverter Defibrillator (ICD)
Time frame: 5 years post randomization
Population: The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| H01: Medication | H01: Cardiac Procedure: Implantable Cardioverter Defibrillator (ICD) | 98 participants |
| H02: Medication+CABG+SVR | H01: Cardiac Procedure: Implantable Cardioverter Defibrillator (ICD) | 76 participants |
Secondary
H01: Cardiac Procedure: Left Ventricular Assist Device (LVAD)
Time frame: 5 years post randomization
Population: The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| H01: Medication | H01: Cardiac Procedure: Left Ventricular Assist Device (LVAD) | 2 participants |
| H02: Medication+CABG+SVR | H01: Cardiac Procedure: Left Ventricular Assist Device (LVAD) | 2 participants |
Secondary
H01: Cardiac Procedure: Left Ventricular Assist Device (LVAD)
Time frame: 10 years post randomization
Population: The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| H01: Medication | H01: Cardiac Procedure: Left Ventricular Assist Device (LVAD) | 2 participants |
| H02: Medication+CABG+SVR | H01: Cardiac Procedure: Left Ventricular Assist Device (LVAD) | 4 participants |
Secondary
H01: Cardiac Self-Efficacy (CSE) Control Symptoms Subscale
These 8 items assess patients' ability to control symptoms such as chest pain and breathlessness by taking their medications and adjusting their activity levels. Response choices range from Not at all confident (1) to Completely confident (5). The mean score is transformed to a 0-100 scale where higher scores reflect more confidence. .
Time frame: From enrollment to 3-year follow-up
Population: Only patients with questionnaire data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| H01: Medication | H01: Cardiac Self-Efficacy (CSE) Control Symptoms Subscale | 4 Months | 69.2 units on a scale | Standard Deviation 20.6 |
| H01: Medication | H01: Cardiac Self-Efficacy (CSE) Control Symptoms Subscale | 24 Months | 68.3 units on a scale | Standard Deviation 20.4 |
| H01: Medication | H01: Cardiac Self-Efficacy (CSE) Control Symptoms Subscale | 12 Months | 68.7 units on a scale | Standard Deviation 20.3 |
| H01: Medication | H01: Cardiac Self-Efficacy (CSE) Control Symptoms Subscale | 36 Months | 69.7 units on a scale | Standard Deviation 21 |
| H01: Medication | H01: Cardiac Self-Efficacy (CSE) Control Symptoms Subscale | Baseline | 62.9 units on a scale | Standard Deviation 22.5 |
| H02: Medication+CABG+SVR | H01: Cardiac Self-Efficacy (CSE) Control Symptoms Subscale | 36 Months | 68.3 units on a scale | Standard Deviation 21.1 |
| H02: Medication+CABG+SVR | H01: Cardiac Self-Efficacy (CSE) Control Symptoms Subscale | Baseline | 64.8 units on a scale | Standard Deviation 21.2 |
| H02: Medication+CABG+SVR | H01: Cardiac Self-Efficacy (CSE) Control Symptoms Subscale | 4 Months | 68.7 units on a scale | Standard Deviation 20.5 |
| H02: Medication+CABG+SVR | H01: Cardiac Self-Efficacy (CSE) Control Symptoms Subscale | 12 Months | 67.4 units on a scale | Standard Deviation 21.8 |
| H02: Medication+CABG+SVR | H01: Cardiac Self-Efficacy (CSE) Control Symptoms Subscale | 24 Months | 66.2 units on a scale | Standard Deviation 21.3 |
p-value: 0.036Chi-squared
p-value: 0.043Chi-squared
p-value: 0.018Chi-squared
p-value: 0.037Chi-squared
Secondary
H01: Cardiac Self-Efficacy (CSE) Maintain Functioning Subscale
These 5 items assess patients' ability to maintain their usual social, family, and physical activities. Response choices range from Not at all confident (1) to Completely confident (5). The mean score is transformed to a 0-100 scale where higher scores reflect more confidence. .
Time frame: From enrollment to 3-year follow-up
Population: Only patients with questionnaire data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| H01: Medication | H01: Cardiac Self-Efficacy (CSE) Maintain Functioning Subscale | 4 Months | 56.0 units on a scale | Standard Deviation 25 |
| H01: Medication | H01: Cardiac Self-Efficacy (CSE) Maintain Functioning Subscale | 24 Months | 55.3 units on a scale | Standard Deviation 25.2 |
| H01: Medication | H01: Cardiac Self-Efficacy (CSE) Maintain Functioning Subscale | 12 Months | 56.7 units on a scale | Standard Deviation 25.9 |
| H01: Medication | H01: Cardiac Self-Efficacy (CSE) Maintain Functioning Subscale | 36 Months | 56.2 units on a scale | Standard Deviation 26 |
| H01: Medication | H01: Cardiac Self-Efficacy (CSE) Maintain Functioning Subscale | Baseline | 46.8 units on a scale | Standard Deviation 24.3 |
| H02: Medication+CABG+SVR | H01: Cardiac Self-Efficacy (CSE) Maintain Functioning Subscale | 36 Months | 54.9 units on a scale | Standard Deviation 26.7 |
| H02: Medication+CABG+SVR | H01: Cardiac Self-Efficacy (CSE) Maintain Functioning Subscale | Baseline | 49.3 units on a scale | Standard Deviation 24.9 |
| H02: Medication+CABG+SVR | H01: Cardiac Self-Efficacy (CSE) Maintain Functioning Subscale | 4 Months | 53.8 units on a scale | Standard Deviation 24.8 |
| H02: Medication+CABG+SVR | H01: Cardiac Self-Efficacy (CSE) Maintain Functioning Subscale | 12 Months | 53.9 units on a scale | Standard Deviation 26.7 |
| H02: Medication+CABG+SVR | H01: Cardiac Self-Efficacy (CSE) Maintain Functioning Subscale | 24 Months | 53.3 units on a scale | Standard Deviation 26.4 |
p-value: 0.002Chi-squared
p-value: 0.007Chi-squared
p-value: 0.049Chi-squared
p-value: 0.038Chi-squared
Secondary
H01: Cardiovascular Mortality (Defined as Sudden Death or Death Attributed to Recurrent MI, HF, a Cardiovascular Procedure, Stroke, or Other Cardiovascular Etiology).
Time frame: 10 years post randomization
Population: The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| H01: Medication | H01: Cardiovascular Mortality (Defined as Sudden Death or Death Attributed to Recurrent MI, HF, a Cardiovascular Procedure, Stroke, or Other Cardiovascular Etiology). | 247 participants |
| H02: Medication+CABG+SVR | H01: Cardiovascular Mortality (Defined as Sudden Death or Death Attributed to Recurrent MI, HF, a Cardiovascular Procedure, Stroke, or Other Cardiovascular Etiology). | 297 participants |
p-value: 0.00695% CI: [0.66, 0.93]Log Rank
Secondary
H01: Cardiovascular Mortality (Defined as Sudden Death or Death Attributed to Recurrent MI, HF, a Cardiovascular Procedure, Stroke, or Other Cardiovascular Etiology).
Time frame: 5 years post randomization
Population: The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| H01: Medication | H01: Cardiovascular Mortality (Defined as Sudden Death or Death Attributed to Recurrent MI, HF, a Cardiovascular Procedure, Stroke, or Other Cardiovascular Etiology). | 168 participants |
| H02: Medication+CABG+SVR | H01: Cardiovascular Mortality (Defined as Sudden Death or Death Attributed to Recurrent MI, HF, a Cardiovascular Procedure, Stroke, or Other Cardiovascular Etiology). | 201 participants |
p-value: 0.0595% CI: [0.66, 1]Log Rank
Secondary
H01: Cost of Care
Hospital costs and physician fees for US patients
Time frame: index hospital admission
Population: US patients with hospital bills
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| H01: Medication | H01: Cost of Care | Hospital Costs | 50,032 2009 US Dollars | — |
| H01: Medication | H01: Cost of Care | Physician Fees | 5,405 2009 US Dollars | — |
| H01: Medication | H01: Cost of Care | Total Index Cost | 55,437 2009 US Dollars | — |
| H02: Medication+CABG+SVR | H01: Cost of Care | Hospital Costs | 8,315 2009 US Dollars | — |
| H02: Medication+CABG+SVR | H01: Cost of Care | Physician Fees | 408 2009 US Dollars | Standard Deviation 819 |
| H02: Medication+CABG+SVR | H01: Cost of Care | Total Index Cost | 8,723 2009 US Dollars | — |
p-value: <0.0001Wilcoxon (Mann-Whitney)
p-value: <0.0001Wilcoxon (Mann-Whitney)
p-value: <0.0001Wilcoxon (Mann-Whitney)
Secondary
H01: EQ-5D Health Status Index Score
This 5-item scale describes a patient's health in terms of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Choices for each dimension are No problems (1), Moderate problems (2), or Extreme problems (3). A scoring algorithm with utility weights is then applied to these 5 items to generate index scores ranging from -0.11 (i.e., 33333) to 1.0 (i.e., 11111) on a scale where 0.0 = death and 1.0 = perfect health. These scores were multiplied by 100 to produce a scale from -11 to 100 that more closely resembles the Visual Analog Scale. .
Time frame: From enrollment to 3-year follow-up
Population: Only patients with questionnaire data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| H01: Medication | H01: EQ-5D Health Status Index Score | 4 Months | 78.9 units on a scale | Standard Deviation 24.5 |
| H01: Medication | H01: EQ-5D Health Status Index Score | 24 Months | 79.6 units on a scale | Standard Deviation 24.6 |
| H01: Medication | H01: EQ-5D Health Status Index Score | 12 Months | 80.5 units on a scale | Standard Deviation 22.3 |
| H01: Medication | H01: EQ-5D Health Status Index Score | 36 Months | 81.4 units on a scale | Standard Deviation 23.4 |
| H01: Medication | H01: EQ-5D Health Status Index Score | Baseline | 69.3 units on a scale | Standard Deviation 25.8 |
| H02: Medication+CABG+SVR | H01: EQ-5D Health Status Index Score | 36 Months | 81.5 units on a scale | Standard Deviation 21.6 |
| H02: Medication+CABG+SVR | H01: EQ-5D Health Status Index Score | Baseline | 72.3 units on a scale | Standard Deviation 24.4 |
| H02: Medication+CABG+SVR | H01: EQ-5D Health Status Index Score | 4 Months | 77.4 units on a scale | Standard Deviation 22.6 |
| H02: Medication+CABG+SVR | H01: EQ-5D Health Status Index Score | 12 Months | 77.6 units on a scale | Standard Deviation 24 |
| H02: Medication+CABG+SVR | H01: EQ-5D Health Status Index Score | 24 Months | 78.1 units on a scale | Standard Deviation 25.9 |
p-value: 0.007Chi-squared
p-value: 0.003Chi-squared
p-value: 0.023Chi-squared
p-value: 0.06Chi-squared
Secondary
H01: EQ-5D Visual Analog Scale
Euro QoL 5 Dimensions Quality of Life Instrument (EQ-5D): This 0-100 scale records the patient's self-rated health on a vertical scale where 0 = worst imaginable health and 100 = perfect health. .
Time frame: From enrollment to 3-year follow-up
Population: Only patients with questionnaire data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| H01: Medication | H01: EQ-5D Visual Analog Scale | 4 Months | 68.5 units on a scale | Standard Deviation 18.1 |
| H01: Medication | H01: EQ-5D Visual Analog Scale | 24 Months | 68.6 units on a scale | Standard Deviation 17.8 |
| H01: Medication | H01: EQ-5D Visual Analog Scale | 12 Months | 69.2 units on a scale | Standard Deviation 17.9 |
| H01: Medication | H01: EQ-5D Visual Analog Scale | 36 Months | 69.0 units on a scale | Standard Deviation 17.9 |
| H01: Medication | H01: EQ-5D Visual Analog Scale | Baseline | 56.7 units on a scale | Standard Deviation 19 |
| H02: Medication+CABG+SVR | H01: EQ-5D Visual Analog Scale | 36 Months | 67.1 units on a scale | Standard Deviation 17.4 |
| H02: Medication+CABG+SVR | H01: EQ-5D Visual Analog Scale | Baseline | 59.5 units on a scale | Standard Deviation 18.8 |
| H02: Medication+CABG+SVR | H01: EQ-5D Visual Analog Scale | 4 Months | 65.4 units on a scale | Standard Deviation 17.7 |
| H02: Medication+CABG+SVR | H01: EQ-5D Visual Analog Scale | 12 Months | 65.4 units on a scale | Standard Deviation 18.5 |
| H02: Medication+CABG+SVR | H01: EQ-5D Visual Analog Scale | 24 Months | 65.9 units on a scale | Standard Deviation 18.4 |
p-value: <0.001Chi-squared
p-value: <0.001Chi-squared
p-value: 0.001Chi-squared
p-value: 0.001Chi-squared
Secondary
H01: Exercise Duration
Record the total duration of exercise in minutes and seconds for patients performing the modified Bruce exercise treadmill test
Time frame: From randomization to 24 months follow-up
Population: Only patients with exercise duration data at baseline or 24 months were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| H01: Medication | H01: Exercise Duration | Baseline | 6.85 minutes | Standard Deviation 3.4 |
| H01: Medication | H01: Exercise Duration | 24 month | 7.78 minutes | Standard Deviation 3.32 |
| H01: Medication | H01: Exercise Duration | Change from baseline to 24 Months | 0.71 minutes | Standard Deviation 3.51 |
| H02: Medication+CABG+SVR | H01: Exercise Duration | Baseline | 6.3 minutes | Standard Deviation 3.39 |
| H02: Medication+CABG+SVR | H01: Exercise Duration | 24 month | 7.97 minutes | Standard Deviation 3.32 |
| H02: Medication+CABG+SVR | H01: Exercise Duration | Change from baseline to 24 Months | 0.83 minutes | Standard Deviation 3.26 |
Secondary
H01: General Health Rating Scale
This single item asks patients to describe their health status over the past month on a scale from 0 to 100, where 0 = death and 100 = excellent health. .
Time frame: From enrollment to 3-year follow-up
Population: Only patients with questionnaire data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| H01: Medication | H01: General Health Rating Scale | 4 Months | 67.3 units on a scale | Standard Deviation 19.1 |
| H01: Medication | H01: General Health Rating Scale | 24 Months | 68.1 units on a scale | Standard Deviation 19.2 |
| H01: Medication | H01: General Health Rating Scale | 12 Months | 68.7 units on a scale | Standard Deviation 18.7 |
| H01: Medication | H01: General Health Rating Scale | 36 Months | 69.1 units on a scale | Standard Deviation 31.6 |
| H01: Medication | H01: General Health Rating Scale | Baseline | 56.0 units on a scale | Standard Deviation 19.4 |
| H02: Medication+CABG+SVR | H01: General Health Rating Scale | 36 Months | 67.1 units on a scale | Standard Deviation 33.7 |
| H02: Medication+CABG+SVR | H01: General Health Rating Scale | Baseline | 57.6 units on a scale | Standard Deviation 19 |
| H02: Medication+CABG+SVR | H01: General Health Rating Scale | 4 Months | 64.0 units on a scale | Standard Deviation 18.1 |
| H02: Medication+CABG+SVR | H01: General Health Rating Scale | 12 Months | 63.7 units on a scale | Standard Deviation 19.1 |
| H02: Medication+CABG+SVR | H01: General Health Rating Scale | 24 Months | 65.0 units on a scale | Standard Deviation 19.6 |
p-value: 0.0002Chi-squared
p-value: <0.0001Chi-squared
p-value: 0.009Chi-squared
p-value: 0.32Chi-squared
Secondary
H01: Heart Failure Hospitalization
Time frame: 5 years post randomization
Population: The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| H01: Medication | H01: Heart Failure Hospitalization | 169 participants |
| H02: Medication+CABG+SVR | H01: Heart Failure Hospitalization | 127 participants |
Secondary
H01: Heart Failure Hospitalization
Time frame: 10 years post randomization
Population: The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| H01: Medication | H01: Heart Failure Hospitalization | 201 participants |
| H02: Medication+CABG+SVR | H01: Heart Failure Hospitalization | 157 participants |
Secondary
H01: KCCQ Clinical Summary Score
This score represents the mean of the Physical Limitation and Total Symptom scores. Mean scores are transformed to a 0-100 scale with high scores representing better outcomes. .
Time frame: From enrollment to 3-year follow-up
Population: Only patients with questionnaire data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| H01: Medication | H01: KCCQ Clinical Summary Score | 4 Months | 78.2 units on a scale | Standard Deviation 20 |
| H01: Medication | H01: KCCQ Clinical Summary Score | 24 Months | 80.1 units on a scale | Standard Deviation 19.5 |
| H01: Medication | H01: KCCQ Clinical Summary Score | 12 Months | 80.6 units on a scale | Standard Deviation 20.3 |
| H01: Medication | H01: KCCQ Clinical Summary Score | 36 Months | 79.9 units on a scale | Standard Deviation 20.2 |
| H01: Medication | H01: KCCQ Clinical Summary Score | Baseline | 68.2 units on a scale | Standard Deviation 21.8 |
| H02: Medication+CABG+SVR | H01: KCCQ Clinical Summary Score | 36 Months | 78.0 units on a scale | Standard Deviation 20.5 |
| H02: Medication+CABG+SVR | H01: KCCQ Clinical Summary Score | Baseline | 68.8 units on a scale | Standard Deviation 23.1 |
| H02: Medication+CABG+SVR | H01: KCCQ Clinical Summary Score | 4 Months | 76.4 units on a scale | Standard Deviation 20.4 |
| H02: Medication+CABG+SVR | H01: KCCQ Clinical Summary Score | 12 Months | 76.4 units on a scale | Standard Deviation 21.9 |
| H02: Medication+CABG+SVR | H01: KCCQ Clinical Summary Score | 24 Months | 76.6 units on a scale | Standard Deviation 22.6 |
p-value: 0.033Chi-squared
p-value: 0.002Chi-squared
p-value: 0.015Chi-squared
p-value: 0.051Chi-squared
Secondary
H01: KCCQ Overall Summary Score
This score represents the mean of these 4 scores: Physical Limitation, Total Symptom, Quality of Life, and Social Limitation. Mean scores are transformed to a 0-100 scale with high scores representing better outcomes. .
Time frame: From enrollment to 3-year follow-up
Population: Only patients with questionnaire data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| H01: Medication | H01: KCCQ Overall Summary Score | 4 Months | 74.3 units on a scale | Standard Deviation 21 |
| H01: Medication | H01: KCCQ Overall Summary Score | 24 Months | 76.9 units on a scale | Standard Deviation 20.1 |
| H01: Medication | H01: KCCQ Overall Summary Score | 12 Months | 77.5 units on a scale | Standard Deviation 20.4 |
| H01: Medication | H01: KCCQ Overall Summary Score | 36 Months | 76.6 units on a scale | Standard Deviation 20.9 |
| H01: Medication | H01: KCCQ Overall Summary Score | Baseline | 60.3 units on a scale | Standard Deviation 22.3 |
| H02: Medication+CABG+SVR | H01: KCCQ Overall Summary Score | 36 Months | 74.5 units on a scale | Standard Deviation 21.4 |
| H02: Medication+CABG+SVR | H01: KCCQ Overall Summary Score | Baseline | 61.3 units on a scale | Standard Deviation 23.2 |
| H02: Medication+CABG+SVR | H01: KCCQ Overall Summary Score | 4 Months | 71.2 units on a scale | Standard Deviation 21.3 |
| H02: Medication+CABG+SVR | H01: KCCQ Overall Summary Score | 12 Months | 72.2 units on a scale | Standard Deviation 22.7 |
| H02: Medication+CABG+SVR | H01: KCCQ Overall Summary Score | 24 Months | 72.9 units on a scale | Standard Deviation 23.4 |
p-value: <0.001Chi-squared
p-value: <0.001Chi-squared
p-value: 0.006Chi-squared
p-value: 0.037Chi-squared
Secondary
H01: KCCQ Physical Limitation Scale
Kansas City Cardiomyopathy Questionnaire (KCCQ)Physical Limitation Scale: These 6 items assess ability to perform various activities of daily living. Response choices range from Extremely limited (1) to Not at all limited (5). Mean scores are transformed to a 0-100 scale with high scores representing better outcomes. .
Time frame: From enrollment to 3-year follow-up
Population: Only patients with questionnaire data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| H01: Medication | H01: KCCQ Physical Limitation Scale | 4 Months | 75.2 units on a scale | Standard Deviation 23.6 |
| H01: Medication | H01: KCCQ Physical Limitation Scale | 24 Months | 76.6 units on a scale | Standard Deviation 23.1 |
| H01: Medication | H01: KCCQ Physical Limitation Scale | 12 Months | 77.8 units on a scale | Standard Deviation 23 |
| H01: Medication | H01: KCCQ Physical Limitation Scale | 36 Months | 76.8 units on a scale | Standard Deviation 22 |
| H01: Medication | H01: KCCQ Physical Limitation Scale | Baseline | 64.2 units on a scale | Standard Deviation 24.7 |
| H02: Medication+CABG+SVR | H01: KCCQ Physical Limitation Scale | 36 Months | 74.9 units on a scale | Standard Deviation 22.4 |
| H02: Medication+CABG+SVR | H01: KCCQ Physical Limitation Scale | Baseline | 64.7 units on a scale | Standard Deviation 26.1 |
| H02: Medication+CABG+SVR | H01: KCCQ Physical Limitation Scale | 4 Months | 73.1 units on a scale | Standard Deviation 23.6 |
| H02: Medication+CABG+SVR | H01: KCCQ Physical Limitation Scale | 12 Months | 73.4 units on a scale | Standard Deviation 24.3 |
| H02: Medication+CABG+SVR | H01: KCCQ Physical Limitation Scale | 24 Months | 73.1 units on a scale | Standard Deviation 25.4 |
p-value: 0.05Chi-squared
p-value: 0.003Chi-squared
p-value: 0.049Chi-squared
p-value: 0.097Chi-squared
Secondary
H01: KCCQ Quality-of-Life Scale
These 3 items assess the effect of heart failure on the patient's enjoyment of life. Response choices range from 1 (worst state) to 5 (best state). Mean scores are transformed to a 0-100 scale with high scores representing better outcomes. .
Time frame: From enrollment to 3-year follow-up
Population: Only patients with questionnaire data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| H01: Medication | H01: KCCQ Quality-of-Life Scale | 4 Months | 68.7 units on a scale | Standard Deviation 24.5 |
| H01: Medication | H01: KCCQ Quality-of-Life Scale | 24 Months | 71.9 units on a scale | Standard Deviation 22.6 |
| H01: Medication | H01: KCCQ Quality-of-Life Scale | 12 Months | 72.9 units on a scale | Standard Deviation 23.5 |
| H01: Medication | H01: KCCQ Quality-of-Life Scale | 36 Months | 71.2 units on a scale | Standard Deviation 23.3 |
| H01: Medication | H01: KCCQ Quality-of-Life Scale | Baseline | 47.9 units on a scale | Standard Deviation 25 |
| H02: Medication+CABG+SVR | H01: KCCQ Quality-of-Life Scale | 36 Months | 69.1 units on a scale | Standard Deviation 24.8 |
| H02: Medication+CABG+SVR | H01: KCCQ Quality-of-Life Scale | Baseline | 50.1 units on a scale | Standard Deviation 27 |
| H02: Medication+CABG+SVR | H01: KCCQ Quality-of-Life Scale | 4 Months | 63.3 units on a scale | Standard Deviation 25.6 |
| H02: Medication+CABG+SVR | H01: KCCQ Quality-of-Life Scale | 12 Months | 65.6 units on a scale | Standard Deviation 25.8 |
| H02: Medication+CABG+SVR | H01: KCCQ Quality-of-Life Scale | 24 Months | 66.9 units on a scale | Standard Deviation 26 |
p-value: <0.001Chi-squared
p-value: <0.001Chi-squared
p-value: <0.001Chi-squared
p-value: 0.018Chi-squared
Secondary
H01: KCCQ Social Limitation
These 4 items assess how much heart failure has affected the patient's lifestyle. Response choices range from Severely limited (1) to Did not limit at all (5). Mean scores are transformed to a 0-100 scale with high scores representing better outcomes. .
Time frame: From enrollment to 3-year follow-up
Population: Only patients with questionnaire data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| H01: Medication | H01: KCCQ Social Limitation | 4 Months | 72.3 units on a scale | Standard Deviation 27.4 |
| H01: Medication | H01: KCCQ Social Limitation | 24 Months | 75.4 units on a scale | Standard Deviation 25.9 |
| H01: Medication | H01: KCCQ Social Limitation | 12 Months | 76.4 units on a scale | Standard Deviation 26 |
| H01: Medication | H01: KCCQ Social Limitation | 36 Months | 75.4 units on a scale | Standard Deviation 27 |
| H01: Medication | H01: KCCQ Social Limitation | Baseline | 56.4 units on a scale | Standard Deviation 29.9 |
| H02: Medication+CABG+SVR | H01: KCCQ Social Limitation | 36 Months | 72.8 units on a scale | Standard Deviation 26.8 |
| H02: Medication+CABG+SVR | H01: KCCQ Social Limitation | Baseline | 57.3 units on a scale | Standard Deviation 29.7 |
| H02: Medication+CABG+SVR | H01: KCCQ Social Limitation | 4 Months | 69.0 units on a scale | Standard Deviation 27 |
| H02: Medication+CABG+SVR | H01: KCCQ Social Limitation | 12 Months | 69.5 units on a scale | Standard Deviation 28.4 |
| H02: Medication+CABG+SVR | H01: KCCQ Social Limitation | 24 Months | 71.0 units on a scale | Standard Deviation 28.8 |
p-value: 0.023Chi-squared
p-value: 0.001Chi-squared
p-value: 0.077Chi-squared
p-value: 0.17Chi-squared
Secondary
H01: KCCQ Symptom Burden
These 3 items assess how much the patient has been bothered by shortness of breath, fatigue, and ankle swelling over the past 2 weeks. Response choices range from extremely bothersome (1) to Not at all bothersome (5). Mean scores are transformed to a 0-100 scale with high scores representing better outcomes.
Time frame: From enrollment to 3-year follow-up
Population: Only patients with questionnaire data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| H01: Medication | H01: KCCQ Symptom Burden | 4 Months | 81.4 units on a scale | Standard Deviation 20.4 |
| H01: Medication | H01: KCCQ Symptom Burden | 24 Months | 83.3 units on a scale | Standard Deviation 20.2 |
| H01: Medication | H01: KCCQ Symptom Burden | 12 Months | 83.7 units on a scale | Standard Deviation 20.6 |
| H01: Medication | H01: KCCQ Symptom Burden | 36 Months | 83.1 units on a scale | Standard Deviation 21.2 |
| H01: Medication | H01: KCCQ Symptom Burden | Baseline | 72.6 units on a scale | Standard Deviation 22.5 |
| H02: Medication+CABG+SVR | H01: KCCQ Symptom Burden | 36 Months | 80.7 units on a scale | Standard Deviation 22.4 |
| H02: Medication+CABG+SVR | H01: KCCQ Symptom Burden | Baseline | 73.4 units on a scale | Standard Deviation 24.4 |
| H02: Medication+CABG+SVR | H01: KCCQ Symptom Burden | 4 Months | 79.6 units on a scale | Standard Deviation 21 |
| H02: Medication+CABG+SVR | H01: KCCQ Symptom Burden | 12 Months | 79.8 units on a scale | Standard Deviation 22.5 |
| H02: Medication+CABG+SVR | H01: KCCQ Symptom Burden | 24 Months | 80.0 units on a scale | Standard Deviation 23.1 |
p-value: 0.05Chi-squared
p-value: 0.006Chi-squared
p-value: 0.039Chi-squared
p-value: 0.074Chi-squared
Secondary
H01: KCCQ Symptom Frequency
These 4 items assess how many times the patient has been bothered by shortness of breath, fatigue, and ankle swelling over the past 2 weeks. Response choices vary, but they range from Every morning or Every night or All of the time (1) to Never over the past 2 weeks (either 5 or 7). Mean scores are transformed to a 0-100 scale with high scores representing better outcomes. .
Time frame: From enrollment to 3-year follow-up
Population: Only patients with questionnaire data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| H01: Medication | H01: KCCQ Symptom Frequency | 4 Months | 79.8 units on a scale | Standard Deviation 21.6 |
| H01: Medication | H01: KCCQ Symptom Frequency | 24 Months | 82.2 units on a scale | Standard Deviation 20.9 |
| H01: Medication | H01: KCCQ Symptom Frequency | 12 Months | 82.4 units on a scale | Standard Deviation 22.2 |
| H01: Medication | H01: KCCQ Symptom Frequency | 36 Months | 81.7 units on a scale | Standard Deviation 22.7 |
| H01: Medication | H01: KCCQ Symptom Frequency | Baseline | 70.5 units on a scale | Standard Deviation 24.6 |
| H02: Medication+CABG+SVR | H01: KCCQ Symptom Frequency | 36 Months | 80.4 units on a scale | Standard Deviation 22.4 |
| H02: Medication+CABG+SVR | H01: KCCQ Symptom Frequency | Baseline | 71.5 units on a scale | Standard Deviation 25.7 |
| H02: Medication+CABG+SVR | H01: KCCQ Symptom Frequency | 4 Months | 79.1 units on a scale | Standard Deviation 21.8 |
| H02: Medication+CABG+SVR | H01: KCCQ Symptom Frequency | 12 Months | 79.2 units on a scale | Standard Deviation 23.5 |
| H02: Medication+CABG+SVR | H01: KCCQ Symptom Frequency | 24 Months | 79.3 units on a scale | Standard Deviation 23.3 |
p-value: 0.205Chi-squared
p-value: 0.017Chi-squared
p-value: 0.028Chi-squared
p-value: 0.123Chi-squared
Secondary
H01: KCCQ Symptom Stability
This item assesses changes in shortness of breath or fatigue over the past 2 weeks. Response choices range from Much worse (1) to Much better (5). Item score is transformed to a 0-100 scale with a high score representing a better outcome. .
Time frame: From enrollment to 3-year follow-up
Population: Only patients with questionnaire data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| H01: Medication | H01: KCCQ Symptom Stability | 4 Months | 58.6 units on a scale | Standard Deviation 20.5 |
| H01: Medication | H01: KCCQ Symptom Stability | 24 Months | 51.7 units on a scale | Standard Deviation 14.5 |
| H01: Medication | H01: KCCQ Symptom Stability | 12 Months | 52.8 units on a scale | Standard Deviation 15.7 |
| H01: Medication | H01: KCCQ Symptom Stability | 36 Months | 50.7 units on a scale | Standard Deviation 14.4 |
| H01: Medication | H01: KCCQ Symptom Stability | Baseline | 53.3 units on a scale | Standard Deviation 23.3 |
| H02: Medication+CABG+SVR | H01: KCCQ Symptom Stability | 36 Months | 50.8 units on a scale | Standard Deviation 14.2 |
| H02: Medication+CABG+SVR | H01: KCCQ Symptom Stability | Baseline | 55.5 units on a scale | Standard Deviation 23.8 |
| H02: Medication+CABG+SVR | H01: KCCQ Symptom Stability | 4 Months | 55.7 units on a scale | Standard Deviation 19.1 |
| H02: Medication+CABG+SVR | H01: KCCQ Symptom Stability | 12 Months | 51.1 units on a scale | Standard Deviation 17.4 |
| H02: Medication+CABG+SVR | H01: KCCQ Symptom Stability | 24 Months | 49.3 units on a scale | Standard Deviation 15.5 |
p-value: 0.005Wilcoxon (Mann-Whitney)
p-value: 0.023Wilcoxon (Mann-Whitney)
p-value: 0.009Wilcoxon (Mann-Whitney)
p-value: 0.26Wilcoxon (Mann-Whitney)
Secondary
H01: KCCQ Total Symptoms
This score represents the mean of the Symptom Frequency and Symptom Burden scores. Mean scores are transformed to a 0-100 scale with high scores representing better outcomes. .
Time frame: From enrollment to 3-year follow-up
Population: Only patients with questionnaire data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| H01: Medication | H01: KCCQ Total Symptoms | 4 Months | 80.8 units on a scale | Standard Deviation 20 |
| H01: Medication | H01: KCCQ Total Symptoms | 24 Months | 82.9 units on a scale | Standard Deviation 19.8 |
| H01: Medication | H01: KCCQ Total Symptoms | 12 Months | 83.2 units on a scale | Standard Deviation 20.5 |
| H01: Medication | H01: KCCQ Total Symptoms | 36 Months | 82.5 units on a scale | Standard Deviation 21.3 |
| H01: Medication | H01: KCCQ Total Symptoms | Baseline | 71.7 units on a scale | Standard Deviation 22.5 |
| H02: Medication+CABG+SVR | H01: KCCQ Total Symptoms | 36 Months | 80.7 units on a scale | Standard Deviation 21.7 |
| H02: Medication+CABG+SVR | H01: KCCQ Total Symptoms | Baseline | 72.6 units on a scale | Standard Deviation 24.2 |
| H02: Medication+CABG+SVR | H01: KCCQ Total Symptoms | 4 Months | 79.5 units on a scale | Standard Deviation 20.5 |
| H02: Medication+CABG+SVR | H01: KCCQ Total Symptoms | 12 Months | 79.6 units on a scale | Standard Deviation 22.1 |
| H02: Medication+CABG+SVR | H01: KCCQ Total Symptoms | 24 Months | 79.8 units on a scale | Standard Deviation 22.6 |
p-value: 0.085Chi-squared
p-value: 0.007Chi-squared
p-value: 0.026Chi-squared
p-value: 0.085Chi-squared
Secondary
H01: LVEF by CMR Core Lab During Follow-up
Left ventricular ejection fraction (LVEF) measured by cardiovascular magnetic resonance (CMR) core lab.
Time frame: From randomization to 24 months follow-up
Population: Only patients with CMR LVEF data at baseline, 4 months or 24 months were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| H01: Medication | H01: LVEF by CMR Core Lab During Follow-up | 4 month | 28.6 Percent ejection fraction | Standard Deviation 11.11 |
| H01: Medication | H01: LVEF by CMR Core Lab During Follow-up | 24 month | 32.72 Percent ejection fraction | Standard Deviation 14.7 |
| H01: Medication | H01: LVEF by CMR Core Lab During Follow-up | Changed from baseline to 4 months | 0.07 Percent ejection fraction | Standard Deviation 8.82 |
| H01: Medication | H01: LVEF by CMR Core Lab During Follow-up | Change from baseline to 24 Months | -1.09 Percent ejection fraction | Standard Deviation 10.63 |
| H01: Medication | H01: LVEF by CMR Core Lab During Follow-up | Baseline | 29.51 Percent ejection fraction | Standard Deviation 11.02 |
| H02: Medication+CABG+SVR | H01: LVEF by CMR Core Lab During Follow-up | Change from baseline to 24 Months | 2.13 Percent ejection fraction | Standard Deviation 13.27 |
| H02: Medication+CABG+SVR | H01: LVEF by CMR Core Lab During Follow-up | Baseline | 23.35 Percent ejection fraction | Standard Deviation 9.49 |
| H02: Medication+CABG+SVR | H01: LVEF by CMR Core Lab During Follow-up | 4 month | 28.63 Percent ejection fraction | Standard Deviation 13.16 |
| H02: Medication+CABG+SVR | H01: LVEF by CMR Core Lab During Follow-up | Changed from baseline to 4 months | 2.85 Percent ejection fraction | Standard Deviation 12.87 |
| H02: Medication+CABG+SVR | H01: LVEF by CMR Core Lab During Follow-up | 24 month | 31.47 Percent ejection fraction | Standard Deviation 9.06 |
Secondary
H01: LVEF by ECHO Core Lab During Follow-up
Left ventricular ejection fraction (LVEF) measured by Echocardiography (ECHO) core lab
Time frame: From randomization to 24 months follow-up
Population: Only patients with ECHO LVEF data at baseline, 4 months or 24 months were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| H01: Medication | H01: LVEF by ECHO Core Lab During Follow-up | 4 month | 30.83 Percent ejection fraction | Standard Deviation 9.41 |
| H01: Medication | H01: LVEF by ECHO Core Lab During Follow-up | 24 month | 31.39 Percent ejection fraction | Standard Deviation 10.75 |
| H01: Medication | H01: LVEF by ECHO Core Lab During Follow-up | Changed from baseline to 4 months | 2.21 Percent ejection fraction | Standard Deviation 8.8 |
| H01: Medication | H01: LVEF by ECHO Core Lab During Follow-up | Change from baseline to 24 Months | 2.2 Percent ejection fraction | Standard Deviation 11.31 |
| H01: Medication | H01: LVEF by ECHO Core Lab During Follow-up | Baseline | 28.69 Percent ejection fraction | Standard Deviation 8.33 |
| H02: Medication+CABG+SVR | H01: LVEF by ECHO Core Lab During Follow-up | Change from baseline to 24 Months | 2.22 Percent ejection fraction | Standard Deviation 10.67 |
| H02: Medication+CABG+SVR | H01: LVEF by ECHO Core Lab During Follow-up | Baseline | 28.43 Percent ejection fraction | Standard Deviation 8.24 |
| H02: Medication+CABG+SVR | H01: LVEF by ECHO Core Lab During Follow-up | 4 month | 30.66 Percent ejection fraction | Standard Deviation 10.73 |
| H02: Medication+CABG+SVR | H01: LVEF by ECHO Core Lab During Follow-up | Changed from baseline to 4 months | 2.06 Percent ejection fraction | Standard Deviation 10.06 |
| H02: Medication+CABG+SVR | H01: LVEF by ECHO Core Lab During Follow-up | 24 month | 31.15 Percent ejection fraction | Standard Deviation 11.14 |
Secondary
H01: LVEF by RN Core Lab During Follow-up
Left ventricular ejection fraction (LVEF) measured by radionuclide (RN) core lab.
Time frame: From randomization to 24 months follow-up
Population: Only patients with RN LVEF data at Baseline, 4-months or 24-months were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| H01: Medication | H01: LVEF by RN Core Lab During Follow-up | 4 month | 27.2 Percent ejection fraction | Standard Deviation 9.5 |
| H01: Medication | H01: LVEF by RN Core Lab During Follow-up | 24 month | 30.65 Percent ejection fraction | Standard Deviation 10.74 |
| H01: Medication | H01: LVEF by RN Core Lab During Follow-up | Changed from baseline to 4 months | 0.99 Percent ejection fraction | Standard Deviation 5.88 |
| H01: Medication | H01: LVEF by RN Core Lab During Follow-up | Change from baseline to 24 Months | 3.99 Percent ejection fraction | Standard Deviation 8.24 |
| H01: Medication | H01: LVEF by RN Core Lab During Follow-up | Baseline | 26.83 Percent ejection fraction | Standard Deviation 8.66 |
| H02: Medication+CABG+SVR | H01: LVEF by RN Core Lab During Follow-up | Change from baseline to 24 Months | 1.77 Percent ejection fraction | Standard Deviation 5.63 |
| H02: Medication+CABG+SVR | H01: LVEF by RN Core Lab During Follow-up | Baseline | 26.66 Percent ejection fraction | Standard Deviation 8.41 |
| H02: Medication+CABG+SVR | H01: LVEF by RN Core Lab During Follow-up | 4 month | 27.81 Percent ejection fraction | Standard Deviation 9.73 |
| H02: Medication+CABG+SVR | H01: LVEF by RN Core Lab During Follow-up | Changed from baseline to 4 months | 2.65 Percent ejection fraction | Standard Deviation 6.36 |
| H02: Medication+CABG+SVR | H01: LVEF by RN Core Lab During Follow-up | 24 month | 27.79 Percent ejection fraction | Standard Deviation 9.05 |
Secondary
H01: Mortality or Cardiovascular Hospitalization
Time frame: up to 5 years post randomization
Population: The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| H01: Medication | H01: Mortality or Cardiovascular Hospitalization | 411 participants |
| H02: Medication+CABG+SVR | H01: Mortality or Cardiovascular Hospitalization | 351 participants |
p-value: <0.00195% CI: [0.64, 0.85]Log Rank
Secondary
H01: Mortality or Cardiovascular Hospitalization
Time frame: up to 10 years post randomization
Population: The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| H01: Medication | H01: Mortality or Cardiovascular Hospitalization | 524 participants |
| H02: Medication+CABG+SVR | H01: Mortality or Cardiovascular Hospitalization | 467 participants |
p-value: <0.00195% CI: [0.64, 0.82]Log Rank
Secondary
H01: Percentage of Patients With a Score of >= 16 on the Center for Epidemiological Studies Depression (CES-D) Scale
These 20 items assess depressive symptomatology, and responses choices range from Rarely or none of the time (0) to Most or all of the time (3). Scale scores can therefore range from 0 to 60, although scores greater than or equal to 16 are considered high. .
Time frame: From enrollment to 3-year follow-up
Population: Only patients with questionnaire data were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| H01: Medication | H01: Percentage of Patients With a Score of >= 16 on the Center for Epidemiological Studies Depression (CES-D) Scale | 4 Months | 26.6 percentage of participants |
| H01: Medication | H01: Percentage of Patients With a Score of >= 16 on the Center for Epidemiological Studies Depression (CES-D) Scale | 24 Months | 24.1 percentage of participants |
| H01: Medication | H01: Percentage of Patients With a Score of >= 16 on the Center for Epidemiological Studies Depression (CES-D) Scale | 12 Months | 25.0 percentage of participants |
| H01: Medication | H01: Percentage of Patients With a Score of >= 16 on the Center for Epidemiological Studies Depression (CES-D) Scale | 36 Months | 22.4 percentage of participants |
| H01: Medication | H01: Percentage of Patients With a Score of >= 16 on the Center for Epidemiological Studies Depression (CES-D) Scale | Baseline | 42.9 percentage of participants |
| H02: Medication+CABG+SVR | H01: Percentage of Patients With a Score of >= 16 on the Center for Epidemiological Studies Depression (CES-D) Scale | 36 Months | 29.5 percentage of participants |
| H02: Medication+CABG+SVR | H01: Percentage of Patients With a Score of >= 16 on the Center for Epidemiological Studies Depression (CES-D) Scale | Baseline | 43.4 percentage of participants |
| H02: Medication+CABG+SVR | H01: Percentage of Patients With a Score of >= 16 on the Center for Epidemiological Studies Depression (CES-D) Scale | 4 Months | 27.5 percentage of participants |
| H02: Medication+CABG+SVR | H01: Percentage of Patients With a Score of >= 16 on the Center for Epidemiological Studies Depression (CES-D) Scale | 12 Months | 26.9 percentage of participants |
| H02: Medication+CABG+SVR | H01: Percentage of Patients With a Score of >= 16 on the Center for Epidemiological Studies Depression (CES-D) Scale | 24 Months | 31.1 percentage of participants |
p-value: 0.86Chi-squared
p-value: 0.78Chi-squared
p-value: 0.55Chi-squared
p-value: 0.027Chi-squared
p-value: 0.031Chi-squared
Secondary
H01: Seattle Angina Questionnaire (SAQ) Anginal Frequency Subscale
These 2 items assess the frequency of chest pain over the last 4 weeks. Response choices range from 4 or more times a day (1) to None (6). The mean response is transformed to a 0-100 scale where higher scores reflect less frequent angina. .
Time frame: From enrollment to 3-year follow-up
Population: Only patients with questionnaire data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| H01: Medication | H01: Seattle Angina Questionnaire (SAQ) Anginal Frequency Subscale | 4 Months | 90.5 units on a scale | Standard Deviation 16.9 |
| H01: Medication | H01: Seattle Angina Questionnaire (SAQ) Anginal Frequency Subscale | 24 Months | 90.5 units on a scale | Standard Deviation 17.2 |
| H01: Medication | H01: Seattle Angina Questionnaire (SAQ) Anginal Frequency Subscale | 12 Months | 90.6 units on a scale | Standard Deviation 16.5 |
| H01: Medication | H01: Seattle Angina Questionnaire (SAQ) Anginal Frequency Subscale | 36 Months | 89.8 units on a scale | Standard Deviation 17.5 |
| H01: Medication | H01: Seattle Angina Questionnaire (SAQ) Anginal Frequency Subscale | Baseline | 74.3 units on a scale | Standard Deviation 26.7 |
| H02: Medication+CABG+SVR | H01: Seattle Angina Questionnaire (SAQ) Anginal Frequency Subscale | 36 Months | 88.5 units on a scale | Standard Deviation 19 |
| H02: Medication+CABG+SVR | H01: Seattle Angina Questionnaire (SAQ) Anginal Frequency Subscale | Baseline | 77.0 units on a scale | Standard Deviation 26.2 |
| H02: Medication+CABG+SVR | H01: Seattle Angina Questionnaire (SAQ) Anginal Frequency Subscale | 4 Months | 84.0 units on a scale | Standard Deviation 23.2 |
| H02: Medication+CABG+SVR | H01: Seattle Angina Questionnaire (SAQ) Anginal Frequency Subscale | 12 Months | 84.0 units on a scale | Standard Deviation 22.4 |
| H02: Medication+CABG+SVR | H01: Seattle Angina Questionnaire (SAQ) Anginal Frequency Subscale | 24 Months | 86.5 units on a scale | Standard Deviation 19.7 |
p-value: <0.001Chi-squared
p-value: <0.001Chi-squared
p-value: <0.001Chi-squared
p-value: 0.01Chi-squared
Secondary
H01: Seattle Angina Questionnaire (SAQ) Anginal Stability Subscale
This item assesses the change in chest pain over the last 4 weeks. Response choices range from Much more often (1) to None (6). The mean response is transformed to a 0-100 scale where 50 represents no change and a higher score indicates less angina. .
Time frame: From enrollment to 3-year follow-up
Population: Only patients with questionnaire data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| H01: Medication | H01: Seattle Angina Questionnaire (SAQ) Anginal Stability Subscale | 4 Months | 58.3 units on a scale | Standard Deviation 20.3 |
| H01: Medication | H01: Seattle Angina Questionnaire (SAQ) Anginal Stability Subscale | 24 Months | 52.9 units on a scale | Standard Deviation 14.9 |
| H01: Medication | H01: Seattle Angina Questionnaire (SAQ) Anginal Stability Subscale | 12 Months | 55.4 units on a scale | Standard Deviation 17.3 |
| H01: Medication | H01: Seattle Angina Questionnaire (SAQ) Anginal Stability Subscale | 36 Months | 53.9 units on a scale | Standard Deviation 16.9 |
| H01: Medication | H01: Seattle Angina Questionnaire (SAQ) Anginal Stability Subscale | Baseline | 56.0 units on a scale | Standard Deviation 27.1 |
| H02: Medication+CABG+SVR | H01: Seattle Angina Questionnaire (SAQ) Anginal Stability Subscale | 36 Months | 53.6 units on a scale | Standard Deviation 15.5 |
| H02: Medication+CABG+SVR | H01: Seattle Angina Questionnaire (SAQ) Anginal Stability Subscale | Baseline | 57.8 units on a scale | Standard Deviation 25 |
| H02: Medication+CABG+SVR | H01: Seattle Angina Questionnaire (SAQ) Anginal Stability Subscale | 4 Months | 55.8 units on a scale | Standard Deviation 20.6 |
| H02: Medication+CABG+SVR | H01: Seattle Angina Questionnaire (SAQ) Anginal Stability Subscale | 12 Months | 53.3 units on a scale | Standard Deviation 17.6 |
| H02: Medication+CABG+SVR | H01: Seattle Angina Questionnaire (SAQ) Anginal Stability Subscale | 24 Months | 52.9 units on a scale | Standard Deviation 17.4 |
p-value: 0.029Chi-squared
p-value: 0.042Chi-squared
p-value: 0.3Chi-squared
p-value: 0.2Chi-squared
Secondary
H01:Seattle Angina Questionnaire (SAQ) Quality-of-Life Subscale
These 3 items measure the patient's general satisfaction with life. Response choices range from 1 (least enjoyment) to 5 (high satisfaction). The mean score is transformed to a 0-100 scale where higher scores reflect better outcomes. .
Time frame: From enrollment to 3-year follow-up
Population: Only patients with questionnaire data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| H01: Medication | H01:Seattle Angina Questionnaire (SAQ) Quality-of-Life Subscale | 4 Months | 74.5 units on a scale | Standard Deviation 22.1 |
| H01: Medication | H01:Seattle Angina Questionnaire (SAQ) Quality-of-Life Subscale | 24 Months | 75.5 units on a scale | Standard Deviation 21.5 |
| H01: Medication | H01:Seattle Angina Questionnaire (SAQ) Quality-of-Life Subscale | 12 Months | 75.8 units on a scale | Standard Deviation 21.2 |
| H01: Medication | H01:Seattle Angina Questionnaire (SAQ) Quality-of-Life Subscale | 36 Months | 75.3 units on a scale | Standard Deviation 22.1 |
| H01: Medication | H01:Seattle Angina Questionnaire (SAQ) Quality-of-Life Subscale | Baseline | 53.6 units on a scale | Standard Deviation 25.9 |
| H02: Medication+CABG+SVR | H01:Seattle Angina Questionnaire (SAQ) Quality-of-Life Subscale | 36 Months | 72.9 units on a scale | Standard Deviation 22.2 |
| H02: Medication+CABG+SVR | H01:Seattle Angina Questionnaire (SAQ) Quality-of-Life Subscale | Baseline | 57.6 units on a scale | Standard Deviation 26.6 |
| H02: Medication+CABG+SVR | H01:Seattle Angina Questionnaire (SAQ) Quality-of-Life Subscale | 4 Months | 67.5 units on a scale | Standard Deviation 24.4 |
| H02: Medication+CABG+SVR | H01:Seattle Angina Questionnaire (SAQ) Quality-of-Life Subscale | 12 Months | 69.1 units on a scale | Standard Deviation 24 |
| H02: Medication+CABG+SVR | H01:Seattle Angina Questionnaire (SAQ) Quality-of-Life Subscale | 24 Months | 68.7 units on a scale | Standard Deviation 24.9 |
p-value: <0.001Chi-squared
p-value: <0.001Chi-squared
p-value: <0.001Chi-squared
p-value: 0.001Chi-squared
Secondary
H01: SF-12 Mental Component Summary (MCS) Scale
Twelve items that reflect both physical and mental health are selected from the SF-36 subscales and combined according to an algebraic formula using published weights and constants: (a) First, the items are coded so that a higher value indicates better health; (b) then indicator variables (1/0) are created for the item response choice categories; (c) next, the 35 indicator variables are weighted using mental regression weights from the general US population and summed to produce the MCS-12 score; and (d) finally, a normalized score (with a mean of 50 and standard deviation of 10) is obtained by adding the mental constant from the scoring table to the sum of the 35 products.
Time frame: From enrollment to 3-year follow-up
Population: Only patients with questionnaire data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| H01: Medication | H01: SF-12 Mental Component Summary (MCS) Scale | 4 Months | 50.5 units on a scale | Standard Deviation 11.8 |
| H01: Medication | H01: SF-12 Mental Component Summary (MCS) Scale | 24 Months | 51.6 units on a scale | Standard Deviation 11.1 |
| H01: Medication | H01: SF-12 Mental Component Summary (MCS) Scale | 12 Months | 51.8 units on a scale | Standard Deviation 12.1 |
| H01: Medication | H01: SF-12 Mental Component Summary (MCS) Scale | 36 Months | 51.6 units on a scale | Standard Deviation 11.4 |
| H01: Medication | H01: SF-12 Mental Component Summary (MCS) Scale | Baseline | 44.6 units on a scale | Standard Deviation 12.6 |
| H02: Medication+CABG+SVR | H01: SF-12 Mental Component Summary (MCS) Scale | 36 Months | 50.9 units on a scale | Standard Deviation 11.9 |
| H02: Medication+CABG+SVR | H01: SF-12 Mental Component Summary (MCS) Scale | Baseline | 45.5 units on a scale | Standard Deviation 13 |
| H02: Medication+CABG+SVR | H01: SF-12 Mental Component Summary (MCS) Scale | 4 Months | 49.2 units on a scale | Standard Deviation 12.3 |
| H02: Medication+CABG+SVR | H01: SF-12 Mental Component Summary (MCS) Scale | 12 Months | 50.3 units on a scale | Standard Deviation 12.6 |
| H02: Medication+CABG+SVR | H01: SF-12 Mental Component Summary (MCS) Scale | 24 Months | 49.7 units on a scale | Standard Deviation 12.6 |
p-value: 0.004Chi-squared
p-value: 0.011Chi-squared
p-value: 0.007Chi-squared
p-value: 0.044Chi-squared
Secondary
H01:SF-12 Physical Component Summary (PCS) Scale
Twelve items that reflect both physical and mental health are selected from the SF-36 subscales and combined according to an algebraic formula using published weights and constants: (a) First, the items are coded so that a higher value indicates better health; (b) then indicator variables (1/0) are created for the item response choice categories; (c) next, the 35 indicator variables are weighted using physical regression weights from the general US population and summed to produce the PCS-12 score; and (d) finally, a normalized score (with a mean of 50 and standard deviation of 10) is obtained by adding the physical constant from the scoring table to the sum of the 35 products.
Time frame: From enrollment to 3-year follow-up
Population: Only patients with questionnaire data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| H01: Medication | H01:SF-12 Physical Component Summary (PCS) Scale | 4 Months | 40.2 units on a scale | Standard Deviation 5.9 |
| H01: Medication | H01:SF-12 Physical Component Summary (PCS) Scale | 24 Months | 41.3 units on a scale | Standard Deviation 5.7 |
| H01: Medication | H01:SF-12 Physical Component Summary (PCS) Scale | 12 Months | 41.0 units on a scale | Standard Deviation 5.3 |
| H01: Medication | H01:SF-12 Physical Component Summary (PCS) Scale | 36 Months | 40.8 units on a scale | Standard Deviation 5.5 |
| H01: Medication | H01:SF-12 Physical Component Summary (PCS) Scale | Baseline | 37.8 units on a scale | Standard Deviation 6.1 |
| H02: Medication+CABG+SVR | H01:SF-12 Physical Component Summary (PCS) Scale | 36 Months | 41.3 units on a scale | Standard Deviation 5.8 |
| H02: Medication+CABG+SVR | H01:SF-12 Physical Component Summary (PCS) Scale | Baseline | 38.4 units on a scale | Standard Deviation 5.7 |
| H02: Medication+CABG+SVR | H01:SF-12 Physical Component Summary (PCS) Scale | 4 Months | 39.9 units on a scale | Standard Deviation 5.8 |
| H02: Medication+CABG+SVR | H01:SF-12 Physical Component Summary (PCS) Scale | 12 Months | 40.0 units on a scale | Standard Deviation 6 |
| H02: Medication+CABG+SVR | H01:SF-12 Physical Component Summary (PCS) Scale | 24 Months | 40.9 units on a scale | Standard Deviation 5.8 |
p-value: 0.051Chi-squared
p-value: 0.003Chi-squared
p-value: 0.065Chi-squared
p-value: 0.83Chi-squared
Secondary
H01: SF-36 Mental Health Subscale
Short Form 36 Health Status Questionnaire (SF-36) Mental Health Subscale: These 5 items assess anxiety, depression, emotional control, and psychological well-being. Response choices range from All of the time (1) to None of the time (6). Item values are summed and then transformed to a 0-100 scale where higher scores indicate better mental health. (Final scores are normalized to a mean of 50 and standard deviation of 10.)
Time frame: From enrollment to 3-year follow-up
Population: Only patients with questionnaire data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| H01: Medication | H01: SF-36 Mental Health Subscale | 4 Months | 48.2 units on a scale | Standard Deviation 10.2 |
| H01: Medication | H01: SF-36 Mental Health Subscale | 24 Months | 48.6 units on a scale | Standard Deviation 10.5 |
| H01: Medication | H01: SF-36 Mental Health Subscale | Baseline | 43.7 units on a scale | Standard Deviation 11.8 |
| H01: Medication | H01: SF-36 Mental Health Subscale | 36 Months | 48.5 units on a scale | Standard Deviation 11.1 |
| H01: Medication | H01: SF-36 Mental Health Subscale | 12 Months | 48.8 units on a scale | Standard Deviation 11.1 |
| H02: Medication+CABG+SVR | H01: SF-36 Mental Health Subscale | 36 Months | 48.2 units on a scale | Standard Deviation 10.8 |
| H02: Medication+CABG+SVR | H01: SF-36 Mental Health Subscale | 4 Months | 47.2 units on a scale | Standard Deviation 11.2 |
| H02: Medication+CABG+SVR | H01: SF-36 Mental Health Subscale | 12 Months | 47.0 units on a scale | Standard Deviation 11.8 |
| H02: Medication+CABG+SVR | H01: SF-36 Mental Health Subscale | 24 Months | 46.8 units on a scale | Standard Deviation 11.8 |
| H02: Medication+CABG+SVR | H01: SF-36 Mental Health Subscale | Baseline | 44.4 units on a scale | Standard Deviation 11.8 |
p-value: 0.015Chi-squared
p-value: 0.002Chi-squared
p-value: 0.011Chi-squared
p-value: 0.44Chi-squared
Secondary
H01:SF-36 Role Emotional Subscale
These 3 items assess limitations and difficulty performing work or other usual activities as a result of any emotional problems (such as feeling depressed or anxious). Response choices are either Yes (1) or No (2). Item values are summed and then transformed to a 0-100 scale where higher scores indicate better outcomes. (Final scores are normalized to a mean of 50 and standard deviation of 10.)
Time frame: From enrollment to 3-year follow-up
Population: Only patients with questionnaire data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| H01: Medication | H01:SF-36 Role Emotional Subscale | 4 Months | 45.3 units on a scale | Standard Deviation 13.2 |
| H01: Medication | H01:SF-36 Role Emotional Subscale | 24 Months | 47.5 units on a scale | Standard Deviation 12.1 |
| H01: Medication | H01:SF-36 Role Emotional Subscale | 12 Months | 46.4 units on a scale | Standard Deviation 12.8 |
| H01: Medication | H01:SF-36 Role Emotional Subscale | 36 Months | 48.0 units on a scale | Standard Deviation 11.8 |
| H01: Medication | H01:SF-36 Role Emotional Subscale | Baseline | 39.0 units on a scale | Standard Deviation 14.2 |
| H02: Medication+CABG+SVR | H01:SF-36 Role Emotional Subscale | 36 Months | 47.0 units on a scale | Standard Deviation 12.4 |
| H02: Medication+CABG+SVR | H01:SF-36 Role Emotional Subscale | Baseline | 40.0 units on a scale | Standard Deviation 14.4 |
| H02: Medication+CABG+SVR | H01:SF-36 Role Emotional Subscale | 4 Months | 44.6 units on a scale | Standard Deviation 13.4 |
| H02: Medication+CABG+SVR | H01:SF-36 Role Emotional Subscale | 12 Months | 45.9 units on a scale | Standard Deviation 13.3 |
| H02: Medication+CABG+SVR | H01:SF-36 Role Emotional Subscale | 24 Months | 46.8 units on a scale | Standard Deviation 12.8 |
p-value: 0.063Chi-squared
p-value: 0.187Chi-squared
p-value: 0.168Chi-squared
p-value: 0.05Chi-squared
Secondary
H01:SF-36 Role Physical Subscale
These 4 items assess limitations and difficulty performing work or other usual activities as a result of one's physical health. Response choices are either Yes (1) or No (2). Item values are summed and then transformed to a 0-100 scale where higher scores indicate better outcomes. (Final scores are normalized to a mean of 50 and standard deviation of 10.)
Time frame: From enrollment to 3-year follow-up
Population: Only patients with questionnaire data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| H01: Medication | H01:SF-36 Role Physical Subscale | 4 Months | 43.0 units on a scale | Standard Deviation 11.8 |
| H01: Medication | H01:SF-36 Role Physical Subscale | 24 Months | 46.6 units on a scale | Standard Deviation 11.4 |
| H01: Medication | H01:SF-36 Role Physical Subscale | 12 Months | 45.7 units on a scale | Standard Deviation 11.4 |
| H01: Medication | H01:SF-36 Role Physical Subscale | 36 Months | 46.0 units on a scale | Standard Deviation 11.2 |
| H01: Medication | H01:SF-36 Role Physical Subscale | Baseline | 36.1 units on a scale | Standard Deviation 10.9 |
| H02: Medication+CABG+SVR | H01:SF-36 Role Physical Subscale | 36 Months | 44.8 units on a scale | Standard Deviation 11.6 |
| H02: Medication+CABG+SVR | H01:SF-36 Role Physical Subscale | Baseline | 36.6 units on a scale | Standard Deviation 11.2 |
| H02: Medication+CABG+SVR | H01:SF-36 Role Physical Subscale | 4 Months | 42.6 units on a scale | Standard Deviation 11.8 |
| H02: Medication+CABG+SVR | H01:SF-36 Role Physical Subscale | 12 Months | 43.1 units on a scale | Standard Deviation 12.2 |
| H02: Medication+CABG+SVR | H01:SF-36 Role Physical Subscale | 24 Months | 44.7 units on a scale | Standard Deviation 12.2 |
p-value: 0.31Chi-squared
p-value: 0.002Chi-squared
p-value: 0.028Chi-squared
p-value: 0.079Chi-squared
Secondary
H01:SF-36 Social Functioning Subscale
These 2 items assess the limitations on social activities with others. Response choices range from Extremely or All of the time (1) to Not at all or None of the time (5). Item values are summed and then transformed to a 0-100 scale where higher scores indicate better social functioning. (Final scores are normalized to a mean of 50 and standard deviation of 10.)
Time frame: From enrollment to 3-year follow-up
Population: Only patients with questionnaire data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| H01: Medication | H01:SF-36 Social Functioning Subscale | 4 Months | 47.0 units on a scale | Standard Deviation 11.1 |
| H01: Medication | H01:SF-36 Social Functioning Subscale | 24 Months | 48.3 units on a scale | Standard Deviation 9.9 |
| H01: Medication | H01:SF-36 Social Functioning Subscale | 12 Months | 48.7 units on a scale | Standard Deviation 10.4 |
| H01: Medication | H01:SF-36 Social Functioning Subscale | 36 Months | 47.8 units on a scale | Standard Deviation 10.3 |
| H01: Medication | H01:SF-36 Social Functioning Subscale | Baseline | 41.8 units on a scale | Standard Deviation 12 |
| H02: Medication+CABG+SVR | H01:SF-36 Social Functioning Subscale | 36 Months | 47.1 units on a scale | Standard Deviation 10.2 |
| H02: Medication+CABG+SVR | H01:SF-36 Social Functioning Subscale | Baseline | 42.1 units on a scale | Standard Deviation 12 |
| H02: Medication+CABG+SVR | H01:SF-36 Social Functioning Subscale | 4 Months | 45.8 units on a scale | Standard Deviation 11.3 |
| H02: Medication+CABG+SVR | H01:SF-36 Social Functioning Subscale | 12 Months | 46.1 units on a scale | Standard Deviation 11.7 |
| H02: Medication+CABG+SVR | H01:SF-36 Social Functioning Subscale | 24 Months | 46.1 units on a scale | Standard Deviation 11.1 |
p-value: 0.039Chi-squared
p-value: 0.002Chi-squared
p-value: 0.008Chi-squared
p-value: 0.31Chi-squared
Secondary
H01:SF-36 Vitality Subscale
These 4 items assess energy level and fatigue. Response choices range from All of the time (1) to None of the time (6). Item values are summed and then transformed to a 0-100 scale where higher scores indicate better vitality. (Final scores are normalized to a mean of 50 and standard deviation of 10.)
Time frame: From enrollment to 3-year follow-up
Population: Only patients with questionnaire data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| H01: Medication | H01:SF-36 Vitality Subscale | 4 Months | 51.6 units on a scale | Standard Deviation 9.8 |
| H01: Medication | H01:SF-36 Vitality Subscale | 24 Months | 51.9 units on a scale | Standard Deviation 9.9 |
| H01: Medication | H01:SF-36 Vitality Subscale | 12 Months | 52.2 units on a scale | Standard Deviation 10.1 |
| H01: Medication | H01:SF-36 Vitality Subscale | 36 Months | 51.4 units on a scale | Standard Deviation 10 |
| H01: Medication | H01:SF-36 Vitality Subscale | Baseline | 46.4 units on a scale | Standard Deviation 10.3 |
| H02: Medication+CABG+SVR | H01:SF-36 Vitality Subscale | 36 Months | 50.6 units on a scale | Standard Deviation 10.4 |
| H02: Medication+CABG+SVR | H01:SF-36 Vitality Subscale | Baseline | 47.5 units on a scale | Standard Deviation 10.9 |
| H02: Medication+CABG+SVR | H01:SF-36 Vitality Subscale | 4 Months | 50.5 units on a scale | Standard Deviation 10.5 |
| H02: Medication+CABG+SVR | H01:SF-36 Vitality Subscale | 12 Months | 49.9 units on a scale | Standard Deviation 10.9 |
| H02: Medication+CABG+SVR | H01:SF-36 Vitality Subscale | 24 Months | 49.4 units on a scale | Standard Deviation 10.5 |
p-value: <0.001Chi-squared
p-value: <0.001Chi-squared
p-value: <0.001Chi-squared
p-value: <0.024Chi-squared
Secondary
H01: Stroke
Time frame: 5 years post randomization
Population: The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| H01: Medication | H01: Stroke | 34 participants |
| H02: Medication+CABG+SVR | H01: Stroke | 41 participants |
Secondary
H01: Stroke
Time frame: 10 years post randomization
Population: The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| H01: Medication | H01: Stroke | 41 participants |
| H02: Medication+CABG+SVR | H01: Stroke | 47 participants |
Secondary
H02: 6 Minute Walk Distance
Time frame: From randomization to 24 month follow-up
Population: Only patients with 6-minute walk distance data at baseline, 4 months or 24 months were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| H01: Medication | H02: 6 Minute Walk Distance | 4 month | 385.89 meters | Standard Deviation 123.49 |
| H01: Medication | H02: 6 Minute Walk Distance | 24 month | 400.66 meters | Standard Deviation 121.67 |
| H01: Medication | H02: 6 Minute Walk Distance | Changed from baseline to 4 months | 44.42 meters | Standard Deviation 122.64 |
| H01: Medication | H02: 6 Minute Walk Distance | Change from baseline to 24 Months | 51.51 meters | Standard Deviation 125.65 |
| H01: Medication | H02: 6 Minute Walk Distance | Baseline | 339.38 meters | Standard Deviation 126.11 |
| H02: Medication+CABG+SVR | H02: 6 Minute Walk Distance | Change from baseline to 24 Months | 55.6 meters | Standard Deviation 112.66 |
| H02: Medication+CABG+SVR | H02: 6 Minute Walk Distance | Baseline | 357.23 meters | Standard Deviation 116.91 |
| H02: Medication+CABG+SVR | H02: 6 Minute Walk Distance | 4 month | 407.03 meters | Standard Deviation 121.38 |
| H02: Medication+CABG+SVR | H02: 6 Minute Walk Distance | Changed from baseline to 4 months | 46.09 meters | Standard Deviation 113.67 |
| H02: Medication+CABG+SVR | H02: 6 Minute Walk Distance | 24 month | 425.18 meters | Standard Deviation 121.46 |
Secondary
H02: All-cause Mortality
Time frame: up to 5 years
Population: The Total H02: Medication + CABG group includes the H02: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| H01: Medication | H02: All-cause Mortality | 141 participants |
| H02: Medication+CABG+SVR | H02: All-cause Mortality | 138 participants |
p-value: 0.9895% CI: [0.79, 1.26]Log Rank
Secondary
H02: All-cause Mortality, Heart Transplant or LVAD
Time frame: 5 years post randomization
Population: The Total H02: Medication + CABG group includes the H02: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| H01: Medication | H02: All-cause Mortality, Heart Transplant or LVAD | 148 participants |
| H02: Medication+CABG+SVR | H02: All-cause Mortality, Heart Transplant or LVAD | 145 participants |
p-value: 0.71795% CI: [0.83, 1.32]Log Rank
Secondary
H02: All-cause Mortality or Heart-failure Hospitalization
Time frame: 5 years post randomization
Population: The Total H02: Medication + CABG group includes the H02: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| H01: Medication | H02: All-cause Mortality or Heart-failure Hospitalization | 211 participants |
| H02: Medication+CABG+SVR | H02: All-cause Mortality or Heart-failure Hospitalization | 214 participants |
p-value: 0.40195% CI: [0.89, 1.31]Log Rank
Secondary
H02: All-cause Mortality or Revascularization (CABG or PCI)
CABG = coronary artery bypass grafting. For patients randomized to CABG or CABG +SVR group, this represents the repeat CABG received during follow-up. PCI = Percutaneous Coronary Intervention.
Time frame: 5 years post randomization
Population: The Total H02: Medication + CABG group includes the H02: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| H01: Medication | H02: All-cause Mortality or Revascularization (CABG or PCI) | 174 participants |
| H02: Medication+CABG+SVR | H02: All-cause Mortality or Revascularization (CABG or PCI) | 152 participants |
p-value: 0.41495% CI: [0.73, 1.13]Log Rank
Secondary
H02: All-cause Mortality Within 30 Days After Randomization
Time frame: 30 days post randomization
Population: The Total H02: Medication + CABG group includes the H02: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| H01: Medication | H02: All-cause Mortality Within 30 Days After Randomization | 22 participants |
| H02: Medication+CABG+SVR | H02: All-cause Mortality Within 30 Days After Randomization | 30 participants |
p-value: 0.27595% CI: [0.78, 2.41]Regression, Logistic
Secondary
H02: All-cause (Unplanned and Elective) Hospitalization
Time frame: 5 years post randomization
Population: The Total H02: Medication + CABG group includes the H02: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| H01: Medication | H02: All-cause (Unplanned and Elective) Hospitalization | 272 participants |
| H02: Medication+CABG+SVR | H02: All-cause (Unplanned and Elective) Hospitalization | 268 participants |
Secondary
H02: B-type Natriuretic Peptide (BNP)
B-type natriuretic peptide (BNP) by Neurohormonal/cytokine/genetic (NCG) core lab during follow-up
Time frame: From randomization to 24 months follow-up
Population: Only patients with BNP data at baseline or 4 months were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| H01: Medication | H02: B-type Natriuretic Peptide (BNP) | Baseline | 453.73 pg/mL | Standard Deviation 563.1 |
| H01: Medication | H02: B-type Natriuretic Peptide (BNP) | 4 month | 460.14 pg/mL | Standard Deviation 508.35 |
| H01: Medication | H02: B-type Natriuretic Peptide (BNP) | Changed from baseline to 4 months | 19.75 pg/mL | Standard Deviation 600.26 |
| H02: Medication+CABG+SVR | H02: B-type Natriuretic Peptide (BNP) | Baseline | 452.45 pg/mL | Standard Deviation 665.06 |
| H02: Medication+CABG+SVR | H02: B-type Natriuretic Peptide (BNP) | 4 month | 467.83 pg/mL | Standard Deviation 579.42 |
| H02: Medication+CABG+SVR | H02: B-type Natriuretic Peptide (BNP) | Changed from baseline to 4 months | 72.23 pg/mL | Standard Deviation 554.2 |
Secondary
H02: Cardiac Procedure: Heart Transplant
Time frame: 5 years post randomization
Population: The Total H02: Medication + CABG group includes the H02: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| H01: Medication | H02: Cardiac Procedure: Heart Transplant | 2 participants |
| H02: Medication+CABG+SVR | H02: Cardiac Procedure: Heart Transplant | 7 participants |
Secondary
H02: Cardiac Procedure: Implantable Cardioverter Defibrillator (ICD)
Time frame: 5 years post randomization
Population: The Total H02: Medication + CABG group includes the H02: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| H01: Medication | H02: Cardiac Procedure: Implantable Cardioverter Defibrillator (ICD) | 100 participants |
| H02: Medication+CABG+SVR | H02: Cardiac Procedure: Implantable Cardioverter Defibrillator (ICD) | 86 participants |
Secondary
H02: Cardiac Procedure: Left Ventricular Assist Device (LVAD)
Time frame: 5 years post randomization
Population: The Total H02: Medication + CABG group includes the H02: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| H01: Medication | H02: Cardiac Procedure: Left Ventricular Assist Device (LVAD) | 2 participants |
| H02: Medication+CABG+SVR | H02: Cardiac Procedure: Left Ventricular Assist Device (LVAD) | 2 participants |
Secondary
H02: Cardiac Self-Efficacy (CSE) Control Symptoms Subscale
These 8 items assess patients' ability to control symptoms such as chest pain and breathlessness by taking their medications and adjusting their activity levels. Response choices range from Not at all confident (1) to Completely confident (5). The mean score is transformed to a 0-100 scale where higher scores reflect more confidence.
Time frame: From enrollment to 3-year follow-up
Population: Only patients with questionnaire data were analyzed.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| H01: Medication | H02: Cardiac Self-Efficacy (CSE) Control Symptoms Subscale | 4 Months | 75 units on a scale |
| H01: Medication | H02: Cardiac Self-Efficacy (CSE) Control Symptoms Subscale | 24 Months | 75 units on a scale |
| H01: Medication | H02: Cardiac Self-Efficacy (CSE) Control Symptoms Subscale | 12 Months | 75 units on a scale |
| H01: Medication | H02: Cardiac Self-Efficacy (CSE) Control Symptoms Subscale | 36 Months | 75 units on a scale |
| H01: Medication | H02: Cardiac Self-Efficacy (CSE) Control Symptoms Subscale | Baseline | 63 units on a scale |
| H02: Medication+CABG+SVR | H02: Cardiac Self-Efficacy (CSE) Control Symptoms Subscale | 36 Months | 75 units on a scale |
| H02: Medication+CABG+SVR | H02: Cardiac Self-Efficacy (CSE) Control Symptoms Subscale | Baseline | 63 units on a scale |
| H02: Medication+CABG+SVR | H02: Cardiac Self-Efficacy (CSE) Control Symptoms Subscale | 4 Months | 75 units on a scale |
| H02: Medication+CABG+SVR | H02: Cardiac Self-Efficacy (CSE) Control Symptoms Subscale | 12 Months | 75 units on a scale |
| H02: Medication+CABG+SVR | H02: Cardiac Self-Efficacy (CSE) Control Symptoms Subscale | 24 Months | 75 units on a scale |
p-value: 0.75Wilcoxon (Mann-Whitney)
p-value: 0.72Wilcoxon (Mann-Whitney)
p-value: 0.77Wilcoxon (Mann-Whitney)
p-value: 0.52Wilcoxon (Mann-Whitney)
p-value: 0.12Wilcoxon (Mann-Whitney)
Secondary
H02: Cardiac Self-Efficacy (CSE) Maintain Functioning Subscale
These 5 items assess patients' ability to maintain their usual social, family, and physical activities. Response choices range from Not at all confident (1) to Completely confident (5). The mean score is transformed to a 0-100 scale where higher scores reflect more confidence.
Time frame: From enrollment to 3-year follow-up
Population: Only patients with questionnaire data were analyzed.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| H01: Medication | H02: Cardiac Self-Efficacy (CSE) Maintain Functioning Subscale | 4 Months | 61 units on a scale |
| H01: Medication | H02: Cardiac Self-Efficacy (CSE) Maintain Functioning Subscale | 24 Months | 63 units on a scale |
| H01: Medication | H02: Cardiac Self-Efficacy (CSE) Maintain Functioning Subscale | 12 Months | 65 units on a scale |
| H01: Medication | H02: Cardiac Self-Efficacy (CSE) Maintain Functioning Subscale | 36 Months | 58 units on a scale |
| H01: Medication | H02: Cardiac Self-Efficacy (CSE) Maintain Functioning Subscale | Baseline | 45 units on a scale |
| H02: Medication+CABG+SVR | H02: Cardiac Self-Efficacy (CSE) Maintain Functioning Subscale | 36 Months | 63 units on a scale |
| H02: Medication+CABG+SVR | H02: Cardiac Self-Efficacy (CSE) Maintain Functioning Subscale | Baseline | 45 units on a scale |
| H02: Medication+CABG+SVR | H02: Cardiac Self-Efficacy (CSE) Maintain Functioning Subscale | 4 Months | 63 units on a scale |
| H02: Medication+CABG+SVR | H02: Cardiac Self-Efficacy (CSE) Maintain Functioning Subscale | 12 Months | 64 units on a scale |
| H02: Medication+CABG+SVR | H02: Cardiac Self-Efficacy (CSE) Maintain Functioning Subscale | 24 Months | 65 units on a scale |
p-value: 0.4Wilcoxon (Mann-Whitney)
p-value: 0.37Wilcoxon (Mann-Whitney)
p-value: 0.98Wilcoxon (Mann-Whitney)
p-value: 0.15Wilcoxon (Mann-Whitney)
p-value: 0.04Wilcoxon (Mann-Whitney)
Secondary
H02: Cost of Care
Hospital costs and physician fees for US patients
Time frame: index hospital admission
Population: US patients with hospital bills
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| H01: Medication | H02: Cost of Care | Hospital Costs | 50,939 2008 US Dollars |
| H01: Medication | H02: Cost of Care | Physician Fees | 5,183 2008 US Dollars |
| H01: Medication | H02: Cost of Care | Total Index Cost | 56,122 2008 US Dollars |
| H02: Medication+CABG+SVR | H02: Cost of Care | Hospital Costs | 64,202 2008 US Dollars |
| H02: Medication+CABG+SVR | H02: Cost of Care | Physician Fees | 6,515 2008 US Dollars |
| H02: Medication+CABG+SVR | H02: Cost of Care | Total Index Cost | 70,717 2008 US Dollars |
p-value: 0.006Wilcoxon (Mann-Whitney)
p-value: <0.0001Wilcoxon (Mann-Whitney)
p-value: 0.004Wilcoxon (Mann-Whitney)
Secondary
H02: EQ-5D Health Status Index Score
This 5-item scale describes a patient's health in terms of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Choices for each dimension are No problems (1), Moderate problems (2), or Extreme problems (3). A scoring algorithm with utility weights is then applied to these 5 items to generate index scores ranging from -0.11 (i.e., 33333) to 1.0 (i.e., 11111) on a scale where 0.0 = death and 1.0 = perfect health. (These scores can be multiplied by 100 to produce a scale from -11 to 100 that more closely resembles the Visual Analog Scale.)
Time frame: From enrollment to 3-year follow-up
Population: Only patients with questionnaire data were analyzed.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| H01: Medication | H02: EQ-5D Health Status Index Score | 4 Months | 85 units on a scale |
| H01: Medication | H02: EQ-5D Health Status Index Score | 24 Months | 85 units on a scale |
| H01: Medication | H02: EQ-5D Health Status Index Score | 12 Months | 85 units on a scale |
| H01: Medication | H02: EQ-5D Health Status Index Score | 36 Months | 85 units on a scale |
| H01: Medication | H02: EQ-5D Health Status Index Score | Baseline | 69 units on a scale |
| H02: Medication+CABG+SVR | H02: EQ-5D Health Status Index Score | 36 Months | 85 units on a scale |
| H02: Medication+CABG+SVR | H02: EQ-5D Health Status Index Score | Baseline | 69 units on a scale |
| H02: Medication+CABG+SVR | H02: EQ-5D Health Status Index Score | 4 Months | 85 units on a scale |
| H02: Medication+CABG+SVR | H02: EQ-5D Health Status Index Score | 12 Months | 85 units on a scale |
| H02: Medication+CABG+SVR | H02: EQ-5D Health Status Index Score | 24 Months | 85 units on a scale |
p-value: 0.31Wilcoxon (Mann-Whitney)
p-value: 0.43Wilcoxon (Mann-Whitney)
p-value: 0.57Wilcoxon (Mann-Whitney)
p-value: 0.95Wilcoxon (Mann-Whitney)
p-value: 0.38Wilcoxon (Mann-Whitney)
Secondary
H02: EQ-5D Visual Analog Scale
This 0-100 scale records the patient's self-rated health on a vertical scale where 0 = worst imaginable health and 100 = perfect health.
Time frame: From enrollment to 3-year follow-up
Population: Only patients with questionnaire data were analyzed.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| H01: Medication | H02: EQ-5D Visual Analog Scale | 4 Months | 70 units on a scale |
| H01: Medication | H02: EQ-5D Visual Analog Scale | 24 Months | 70 units on a scale |
| H01: Medication | H02: EQ-5D Visual Analog Scale | 12 Months | 72 units on a scale |
| H01: Medication | H02: EQ-5D Visual Analog Scale | 36 Months | 70 units on a scale |
| H01: Medication | H02: EQ-5D Visual Analog Scale | Baseline | 50 units on a scale |
| H02: Medication+CABG+SVR | H02: EQ-5D Visual Analog Scale | 36 Months | 70 units on a scale |
| H02: Medication+CABG+SVR | H02: EQ-5D Visual Analog Scale | Baseline | 50 units on a scale |
| H02: Medication+CABG+SVR | H02: EQ-5D Visual Analog Scale | 4 Months | 70 units on a scale |
| H02: Medication+CABG+SVR | H02: EQ-5D Visual Analog Scale | 12 Months | 70 units on a scale |
| H02: Medication+CABG+SVR | H02: EQ-5D Visual Analog Scale | 24 Months | 70 units on a scale |
p-value: 0.96Wilcoxon (Mann-Whitney)
p-value: 0.53Wilcoxon (Mann-Whitney)
p-value: 0.37Wilcoxon (Mann-Whitney)
p-value: 0.78Wilcoxon (Mann-Whitney)
p-value: 0.21Wilcoxon (Mann-Whitney)
Secondary
H02: Exercise Duration
Record the total duration of exercise in minutes and seconds for patients performing the modified Bruce exercise treadmill test
Time frame: From randomization to 24 months follow-up
Population: Only patients with exercise duration data at baseline or 24 months were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| H01: Medication | H02: Exercise Duration | Baseline | 6.19 meters | Standard Deviation 3.42 |
| H01: Medication | H02: Exercise Duration | 24 month | 7.67 meters | Standard Deviation 3.3 |
| H01: Medication | H02: Exercise Duration | Change from baseline to 24 Months | 1.15 meters | Standard Deviation 3.01 |
| H02: Medication+CABG+SVR | H02: Exercise Duration | Baseline | 7.16 meters | Standard Deviation 3.47 |
| H02: Medication+CABG+SVR | H02: Exercise Duration | 24 month | 8.41 meters | Standard Deviation 3.41 |
| H02: Medication+CABG+SVR | H02: Exercise Duration | Change from baseline to 24 Months | 0.47 meters | Standard Deviation 3.42 |
Secondary
H02: General Health Rating Scale
This single item asks patients to describe their health status over the past month on a scale from 0 to 100, where 0 = death and 100 = excellent health.
Time frame: From enrollment to 3-year follow-up
Population: Only patients with questionnaire data were analyzed.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| H01: Medication | H02: General Health Rating Scale | Baseline | 50 units on a scale |
| H01: Medication | H02: General Health Rating Scale | 24 Months | 70 units on a scale |
| H01: Medication | H02: General Health Rating Scale | 4 Months | 70 units on a scale |
| H01: Medication | H02: General Health Rating Scale | 36 Months | 70 units on a scale |
| H01: Medication | H02: General Health Rating Scale | 12 Months | 70 units on a scale |
| H02: Medication+CABG+SVR | H02: General Health Rating Scale | 36 Months | 70 units on a scale |
| H02: Medication+CABG+SVR | H02: General Health Rating Scale | 12 Months | 70 units on a scale |
| H02: Medication+CABG+SVR | H02: General Health Rating Scale | 24 Months | 70 units on a scale |
| H02: Medication+CABG+SVR | H02: General Health Rating Scale | Baseline | 50 units on a scale |
| H02: Medication+CABG+SVR | H02: General Health Rating Scale | 4 Months | 70 units on a scale |
p-value: 0.6Wilcoxon (Mann-Whitney)
p-value: 0.14Wilcoxon (Mann-Whitney)
p-value: 0.57Wilcoxon (Mann-Whitney)
p-value: 0.15Wilcoxon (Mann-Whitney)
p-value: 0.84Wilcoxon (Mann-Whitney)
Secondary
H02: Heart Failure Hospitalization
Time frame: 5 years post randomization
Population: The Total H02: Medication + CABG group includes the H02: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| H01: Medication | H02: Heart Failure Hospitalization | 95 participants |
| H02: Medication+CABG+SVR | H02: Heart Failure Hospitalization | 99 participants |
Secondary
H02: KCCQ Clinical Summary Score
This score represents the mean of the Physical Limitation and Total Symptom scores. Mean scores are transformed to a 0-100 scale with high scores representing better outcomes.
Time frame: From enrollment to 3-year follow-up
Population: Only patients with questionnaire data were analyzed.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| H01: Medication | H02: KCCQ Clinical Summary Score | 4 Months | 84 units on a scale |
| H01: Medication | H02: KCCQ Clinical Summary Score | 24 Months | 88 units on a scale |
| H01: Medication | H02: KCCQ Clinical Summary Score | 12 Months | 88 units on a scale |
| H01: Medication | H02: KCCQ Clinical Summary Score | 36 Months | 88 units on a scale |
| H01: Medication | H02: KCCQ Clinical Summary Score | Baseline | 65 units on a scale |
| H02: Medication+CABG+SVR | H02: KCCQ Clinical Summary Score | 36 Months | 88 units on a scale |
| H02: Medication+CABG+SVR | H02: KCCQ Clinical Summary Score | Baseline | 68 units on a scale |
| H02: Medication+CABG+SVR | H02: KCCQ Clinical Summary Score | 4 Months | 84 units on a scale |
| H02: Medication+CABG+SVR | H02: KCCQ Clinical Summary Score | 12 Months | 86 units on a scale |
| H02: Medication+CABG+SVR | H02: KCCQ Clinical Summary Score | 24 Months | 87 units on a scale |
p-value: 0.26Wilcoxon (Mann-Whitney)
p-value: 0.23Wilcoxon (Mann-Whitney)
p-value: 0.66Wilcoxon (Mann-Whitney)
p-value: 0.98Wilcoxon (Mann-Whitney)
p-value: 0.86Wilcoxon (Mann-Whitney)
Secondary
H02: KCCQ Overall Summary Score
This score represents the mean of these 4 scores: Physical Limitation, Total Symptom, Quality of Life, and Social Limitation. Mean scores are transformed to a 0-100 scale with high scores representing better outcomes.
Time frame: From enrollment to 3-year follow-up
Population: Only patients with questionnaire data were analyzed.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| H01: Medication | H02: KCCQ Overall Summary Score | 4 Months | 79 units on a scale |
| H01: Medication | H02: KCCQ Overall Summary Score | 24 Months | 84 units on a scale |
| H01: Medication | H02: KCCQ Overall Summary Score | 12 Months | 84 units on a scale |
| H01: Medication | H02: KCCQ Overall Summary Score | 36 Months | 85 units on a scale |
| H01: Medication | H02: KCCQ Overall Summary Score | Baseline | 53 units on a scale |
| H02: Medication+CABG+SVR | H02: KCCQ Overall Summary Score | 36 Months | 84 units on a scale |
| H02: Medication+CABG+SVR | H02: KCCQ Overall Summary Score | Baseline | 54 units on a scale |
| H02: Medication+CABG+SVR | H02: KCCQ Overall Summary Score | 4 Months | 79 units on a scale |
| H02: Medication+CABG+SVR | H02: KCCQ Overall Summary Score | 12 Months | 82 units on a scale |
| H02: Medication+CABG+SVR | H02: KCCQ Overall Summary Score | 24 Months | 84 units on a scale |
p-value: 0.53Wilcoxon (Mann-Whitney)
p-value: 0.26Wilcoxon (Mann-Whitney)
p-value: 0.76Wilcoxon (Mann-Whitney)
p-value: 0.89Wilcoxon (Mann-Whitney)
p-value: 0.89Wilcoxon (Mann-Whitney)
Secondary
H02: KCCQ Physical Limitation Scale
These 6 items assess ability to perform various activities of daily living. Response choices range from Extremely limited (1) to Not at all limited (5). Mean scores are transformed to a 0-100 scale with high scores representing better outcomes.
Time frame: From enrollment to 3-year follow-up
Population: Only patients with questionnaire data were analyzed.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| H01: Medication | H02: KCCQ Physical Limitation Scale | 4 Months | 83 units on a scale |
| H01: Medication | H02: KCCQ Physical Limitation Scale | 24 Months | 88 units on a scale |
| H01: Medication | H02: KCCQ Physical Limitation Scale | 12 Months | 84 units on a scale |
| H01: Medication | H02: KCCQ Physical Limitation Scale | 36 Months | 88 units on a scale |
| H01: Medication | H02: KCCQ Physical Limitation Scale | Baseline | 63 units on a scale |
| H02: Medication+CABG+SVR | H02: KCCQ Physical Limitation Scale | 36 Months | 88 units on a scale |
| H02: Medication+CABG+SVR | H02: KCCQ Physical Limitation Scale | Baseline | 63 units on a scale |
| H02: Medication+CABG+SVR | H02: KCCQ Physical Limitation Scale | 4 Months | 83 units on a scale |
| H02: Medication+CABG+SVR | H02: KCCQ Physical Limitation Scale | 12 Months | 88 units on a scale |
| H02: Medication+CABG+SVR | H02: KCCQ Physical Limitation Scale | 24 Months | 85 units on a scale |
p-value: 0.4Wilcoxon (Mann-Whitney)
p-value: 0.13Wilcoxon (Mann-Whitney)
p-value: 0.86Wilcoxon (Mann-Whitney)
p-value: 0.89Wilcoxon (Mann-Whitney)
p-value: 0.87Wilcoxon (Mann-Whitney)
Secondary
H02: KCCQ Quality-of-Life Scale
These 3 items assess the effect of heart failure on the patient's enjoyment of life. Response choices range from 1 (worst state) to 5 (best state). Mean scores are transformed to a 0-100 scale with high scores representing better outcomes.
Time frame: From enrollment to 3-year follow-up
Population: Only patients with questionnaire data were analyzed.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| H01: Medication | H02: KCCQ Quality-of-Life Scale | 4 Months | 75 units on a scale |
| H01: Medication | H02: KCCQ Quality-of-Life Scale | 24 Months | 75 units on a scale |
| H01: Medication | H02: KCCQ Quality-of-Life Scale | 12 Months | 75 units on a scale |
| H01: Medication | H02: KCCQ Quality-of-Life Scale | 36 Months | 75 units on a scale |
| H01: Medication | H02: KCCQ Quality-of-Life Scale | Baseline | 42 units on a scale |
| H02: Medication+CABG+SVR | H02: KCCQ Quality-of-Life Scale | 36 Months | 83 units on a scale |
| H02: Medication+CABG+SVR | H02: KCCQ Quality-of-Life Scale | Baseline | 33 units on a scale |
| H02: Medication+CABG+SVR | H02: KCCQ Quality-of-Life Scale | 4 Months | 75 units on a scale |
| H02: Medication+CABG+SVR | H02: KCCQ Quality-of-Life Scale | 12 Months | 75 units on a scale |
| H02: Medication+CABG+SVR | H02: KCCQ Quality-of-Life Scale | 24 Months | 75 units on a scale |
p-value: 0.7Wilcoxon (Mann-Whitney)
p-value: 0.47Wilcoxon (Mann-Whitney)
p-value: 0.87Wilcoxon (Mann-Whitney)
p-value: 0.84Wilcoxon (Mann-Whitney)
p-value: 0.82Wilcoxon (Mann-Whitney)
Secondary
H02: KCCQ Social Limitation
These 4 items assess how much heart failure has affected the patient's lifestyle. Response choices range from Severely limited (1) to Did not limit at all (5). Mean scores are transformed to a 0-100 scale with high scores representing better outcomes.
Time frame: From enrollment to 3-year follow-up
Population: Only patients with questionnaire data were analyzed.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| H01: Medication | H02: KCCQ Social Limitation | 4 Months | 75 units on a scale |
| H01: Medication | H02: KCCQ Social Limitation | 24 Months | 81 units on a scale |
| H01: Medication | H02: KCCQ Social Limitation | 12 Months | 81 units on a scale |
| H01: Medication | H02: KCCQ Social Limitation | 36 Months | 83 units on a scale |
| H01: Medication | H02: KCCQ Social Limitation | Baseline | 44 units on a scale |
| H02: Medication+CABG+SVR | H02: KCCQ Social Limitation | 36 Months | 83 units on a scale |
| H02: Medication+CABG+SVR | H02: KCCQ Social Limitation | Baseline | 44 units on a scale |
| H02: Medication+CABG+SVR | H02: KCCQ Social Limitation | 4 Months | 75 units on a scale |
| H02: Medication+CABG+SVR | H02: KCCQ Social Limitation | 12 Months | 83 units on a scale |
| H02: Medication+CABG+SVR | H02: KCCQ Social Limitation | 24 Months | 86 units on a scale |
p-value: 0.63Wilcoxon (Mann-Whitney)
p-value: 0.29Wilcoxon (Mann-Whitney)
p-value: 0.68Wilcoxon (Mann-Whitney)
p-value: 0.25Wilcoxon (Mann-Whitney)
p-value: 0.68Wilcoxon (Mann-Whitney)
Secondary
H02: KCCQ Symptom Burden
These 3 items assess how much the patient has been bothered by shortness of breath, fatigue, and ankle swelling over the past 2 weeks. Response choices range from extremely bothersome (1) to Not at all bothersome (5). Mean scores are transformed to a 0-100 scale with high scores representing better outcomes.
Time frame: From enrollment to 3-year follow-up
Population: Only patients with questionnaire data were analyzed.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| H01: Medication | H02: KCCQ Symptom Burden | 4 Months | 83 units on a scale |
| H01: Medication | H02: KCCQ Symptom Burden | 24 Months | 92 units on a scale |
| H01: Medication | H02: KCCQ Symptom Burden | 12 Months | 92 units on a scale |
| H01: Medication | H02: KCCQ Symptom Burden | 36 Months | 92 units on a scale |
| H01: Medication | H02: KCCQ Symptom Burden | Baseline | 67 units on a scale |
| H02: Medication+CABG+SVR | H02: KCCQ Symptom Burden | 36 Months | 92 units on a scale |
| H02: Medication+CABG+SVR | H02: KCCQ Symptom Burden | Baseline | 75 units on a scale |
| H02: Medication+CABG+SVR | H02: KCCQ Symptom Burden | 4 Months | 83 units on a scale |
| H02: Medication+CABG+SVR | H02: KCCQ Symptom Burden | 12 Months | 92 units on a scale |
| H02: Medication+CABG+SVR | H02: KCCQ Symptom Burden | 24 Months | 92 units on a scale |
p-value: 0.23Wilcoxon (Mann-Whitney)
p-value: 0.43Wilcoxon (Mann-Whitney)
p-value: 0.35Wilcoxon (Mann-Whitney)
p-value: 0.9Wilcoxon (Mann-Whitney)
p-value: 0.48Wilcoxon (Mann-Whitney)
Secondary
H02: KCCQ Symptom Frequency
These 4 items assess how many times the patient has been bothered by shortness of breath, fatigue, and ankle swelling over the past 2 weeks. Response choices vary, but they range from Every morning or Every night or All of the time (1) to Never over the past 2 weeks (either 5 or 7). Mean scores are transformed to a 0-100 scale with high scores representing better outcomes.
Time frame: From enrollment to 3-year follow-up
Population: Only patients with questionnaire data were analyzed.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| H01: Medication | H02: KCCQ Symptom Frequency | 4 Months | 83 units on a scale |
| H01: Medication | H02: KCCQ Symptom Frequency | 24 Months | 92 units on a scale |
| H01: Medication | H02: KCCQ Symptom Frequency | 12 Months | 90 units on a scale |
| H01: Medication | H02: KCCQ Symptom Frequency | 36 Months | 92 units on a scale |
| H01: Medication | H02: KCCQ Symptom Frequency | Baseline | 67 units on a scale |
| H02: Medication+CABG+SVR | H02: KCCQ Symptom Frequency | 36 Months | 92 units on a scale |
| H02: Medication+CABG+SVR | H02: KCCQ Symptom Frequency | Baseline | 71 units on a scale |
| H02: Medication+CABG+SVR | H02: KCCQ Symptom Frequency | 4 Months | 88 units on a scale |
| H02: Medication+CABG+SVR | H02: KCCQ Symptom Frequency | 12 Months | 90 units on a scale |
| H02: Medication+CABG+SVR | H02: KCCQ Symptom Frequency | 24 Months | 92 units on a scale |
p-value: 0.19Wilcoxon (Mann-Whitney)
p-value: 0.07Wilcoxon (Mann-Whitney)
p-value: 0.94Wilcoxon (Mann-Whitney)
p-value: 0.67Wilcoxon (Mann-Whitney)
p-value: 0.44Wilcoxon (Mann-Whitney)
Secondary
H02: KCCQ Symptom Stability
This item assesses changes in shortness of breath or fatigue over the past 2 weeks. Response choices range from Much worse (1) to Much better (5). Item score is transformed to a 0-100 scale with a high score representing a better outcome.
Time frame: From enrollment to 3-year follow-up
Population: Only patients with questionnaire data were analyzed.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| H01: Medication | H02: KCCQ Symptom Stability | 4 Months | 50 units on a scale |
| H01: Medication | H02: KCCQ Symptom Stability | 24 Months | 50 units on a scale |
| H01: Medication | H02: KCCQ Symptom Stability | 12 Months | 50 units on a scale |
| H01: Medication | H02: KCCQ Symptom Stability | 36 Months | 50 units on a scale |
| H01: Medication | H02: KCCQ Symptom Stability | Baseline | 50 units on a scale |
| H02: Medication+CABG+SVR | H02: KCCQ Symptom Stability | 36 Months | 50 units on a scale |
| H02: Medication+CABG+SVR | H02: KCCQ Symptom Stability | Baseline | 50 units on a scale |
| H02: Medication+CABG+SVR | H02: KCCQ Symptom Stability | 4 Months | 50 units on a scale |
| H02: Medication+CABG+SVR | H02: KCCQ Symptom Stability | 12 Months | 50 units on a scale |
| H02: Medication+CABG+SVR | H02: KCCQ Symptom Stability | 24 Months | 50 units on a scale |
p-value: 0.38Wilcoxon (Mann-Whitney)
p-value: 0.45Wilcoxon (Mann-Whitney)
p-value: 0.62Wilcoxon (Mann-Whitney)
p-value: 0.82Wilcoxon (Mann-Whitney)
p-value: 0.94Wilcoxon (Mann-Whitney)
Secondary
H02: KCCQ Total Symptoms
This score represents the mean of the Symptom Frequency and Symptom Burden scores. Mean scores are transformed to a 0-100 scale with high scores representing better outcomes.
Time frame: From enrollment to 3-year follow-up
Population: Only patients with questionnaire data were analyzed.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| H01: Medication | H02: KCCQ Total Symptoms | 12 Months | 90 units on a scale |
| H01: Medication | H02: KCCQ Total Symptoms | 4 Months | 84 units on a scale |
| H01: Medication | H02: KCCQ Total Symptoms | 24 Months | 90 units on a scale |
| H01: Medication | H02: KCCQ Total Symptoms | 36 Months | 90 units on a scale |
| H01: Medication | H02: KCCQ Total Symptoms | Baseline | 68 units on a scale |
| H02: Medication+CABG+SVR | H02: KCCQ Total Symptoms | 36 Months | 92 units on a scale |
| H02: Medication+CABG+SVR | H02: KCCQ Total Symptoms | Baseline | 71 units on a scale |
| H02: Medication+CABG+SVR | H02: KCCQ Total Symptoms | 4 Months | 88 units on a scale |
| H02: Medication+CABG+SVR | H02: KCCQ Total Symptoms | 12 Months | 88 units on a scale |
| H02: Medication+CABG+SVR | H02: KCCQ Total Symptoms | 24 Months | 90 units on a scale |
p-value: 0.18Wilcoxon (Mann-Whitney)
p-value: 0.17Wilcoxon (Mann-Whitney)
p-value: 0.59Wilcoxon (Mann-Whitney)
p-value: 0.78Wilcoxon (Mann-Whitney)
p-value: 0.48Wilcoxon (Mann-Whitney)
Secondary
H02: LVEF by CMR Core Lab During Follow-up
Left ventricular ejection fraction (LVEF) measured by cardiovascular magnetic resonance (CMR) core lab.
Time frame: From randomization to 24 months follow-up
Population: Only patients with CMR LVEF data at baseline, 4 months or 24 months were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| H01: Medication | H02: LVEF by CMR Core Lab During Follow-up | Change from baseline to 24 Months | -0.51 Percent ejection fraction | Standard Deviation 14.61 |
| H01: Medication | H02: LVEF by CMR Core Lab During Follow-up | Baseline | 27.82 Percent ejection fraction | Standard Deviation 10.26 |
| H01: Medication | H02: LVEF by CMR Core Lab During Follow-up | 4 month | 31.65 Percent ejection fraction | Standard Deviation 13.53 |
| H01: Medication | H02: LVEF by CMR Core Lab During Follow-up | Changed from baseline to 4 months | 2.84 Percent ejection fraction | Standard Deviation 11.86 |
| H01: Medication | H02: LVEF by CMR Core Lab During Follow-up | 24 month | 28.46 Percent ejection fraction | Standard Deviation 10.57 |
| H02: Medication+CABG+SVR | H02: LVEF by CMR Core Lab During Follow-up | 24 month | 33.1 Percent ejection fraction | Standard Deviation 13.79 |
| H02: Medication+CABG+SVR | H02: LVEF by CMR Core Lab During Follow-up | Changed from baseline to 4 months | 7.1 Percent ejection fraction | Standard Deviation 11.86 |
| H02: Medication+CABG+SVR | H02: LVEF by CMR Core Lab During Follow-up | Baseline | 27.25 Percent ejection fraction | Standard Deviation 11.47 |
| H02: Medication+CABG+SVR | H02: LVEF by CMR Core Lab During Follow-up | Change from baseline to 24 Months | 5.39 Percent ejection fraction | Standard Deviation 13.23 |
| H02: Medication+CABG+SVR | H02: LVEF by CMR Core Lab During Follow-up | 4 month | 34.37 Percent ejection fraction | Standard Deviation 13.41 |
Secondary
H02: LVEF by ECHO Core Lab During Follow-up
Left ventricular ejection fraction (LVEF) measured by Echocardiography (ECHO) core lab
Time frame: From randomization to 24 months follow-up
Population: Only patients with ECHO LVEF data at baseline, 4 months or 24 months were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| H01: Medication | H02: LVEF by ECHO Core Lab During Follow-up | 4 month | 31.47 Percent ejection fraction | Standard Deviation 10.4 |
| H01: Medication | H02: LVEF by ECHO Core Lab During Follow-up | 24 month | 31.89 Percent ejection fraction | Standard Deviation 11.38 |
| H01: Medication | H02: LVEF by ECHO Core Lab During Follow-up | Changed from baseline to 4 months | 2.16 Percent ejection fraction | Standard Deviation 10.23 |
| H01: Medication | H02: LVEF by ECHO Core Lab During Follow-up | Change from baseline to 24 Months | 2.24 Percent ejection fraction | Standard Deviation 11.11 |
| H01: Medication | H02: LVEF by ECHO Core Lab During Follow-up | Baseline | 29.13 Percent ejection fraction | Standard Deviation 7.74 |
| H02: Medication+CABG+SVR | H02: LVEF by ECHO Core Lab During Follow-up | Change from baseline to 24 Months | 2.93 Percent ejection fraction | Standard Deviation 10.95 |
| H02: Medication+CABG+SVR | H02: LVEF by ECHO Core Lab During Follow-up | Baseline | 29.49 Percent ejection fraction | Standard Deviation 8.23 |
| H02: Medication+CABG+SVR | H02: LVEF by ECHO Core Lab During Follow-up | 4 month | 33.35 Percent ejection fraction | Standard Deviation 9.79 |
| H02: Medication+CABG+SVR | H02: LVEF by ECHO Core Lab During Follow-up | Changed from baseline to 4 months | 3.04 Percent ejection fraction | Standard Deviation 9.7 |
| H02: Medication+CABG+SVR | H02: LVEF by ECHO Core Lab During Follow-up | 24 month | 33.55 Percent ejection fraction | Standard Deviation 10.91 |
Secondary
H02: LVEF by RN Core Lab During Follow-up
Left ventricular ejection fraction (LVEF) measured by radionuclide (RN) core lab.
Time frame: From randomization to 24 months follow-up
Population: Only patients with RN LVEF data at Baseline, 4-months or 24-months were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| H01: Medication | H02: LVEF by RN Core Lab During Follow-up | 4 month | 30.65 Percent ejection fraction | Standard Deviation 10.41 |
| H01: Medication | H02: LVEF by RN Core Lab During Follow-up | 24 month | 29.95 Percent ejection fraction | Standard Deviation 10.97 |
| H01: Medication | H02: LVEF by RN Core Lab During Follow-up | Changed from baseline to 4 months | 2.23 Percent ejection fraction | Standard Deviation 7.11 |
| H01: Medication | H02: LVEF by RN Core Lab During Follow-up | Change from baseline to 24 Months | 2.01 Percent ejection fraction | Standard Deviation 9.58 |
| H01: Medication | H02: LVEF by RN Core Lab During Follow-up | Baseline | 27.14 Percent ejection fraction | Standard Deviation 8.18 |
| H02: Medication+CABG+SVR | H02: LVEF by RN Core Lab During Follow-up | Change from baseline to 24 Months | 6.79 Percent ejection fraction | Standard Deviation 9.12 |
| H02: Medication+CABG+SVR | H02: LVEF by RN Core Lab During Follow-up | Baseline | 26.55 Percent ejection fraction | Standard Deviation 7.83 |
| H02: Medication+CABG+SVR | H02: LVEF by RN Core Lab During Follow-up | 4 month | 33.5 Percent ejection fraction | Standard Deviation 9.42 |
| H02: Medication+CABG+SVR | H02: LVEF by RN Core Lab During Follow-up | Changed from baseline to 4 months | 6.49 Percent ejection fraction | Standard Deviation 7.91 |
| H02: Medication+CABG+SVR | H02: LVEF by RN Core Lab During Follow-up | 24 month | 34.2 Percent ejection fraction | Standard Deviation 10.3 |
Secondary
H02: Percentage of Patients With a Score of >= 16 on the Center for Epidemiological Studies Depression (CES-D) Scale
These 20 items assess depressive symptomatology, and responses choices range from Rarely or none of the time (0) to Most or all of the time (3). Scale scores can therefore range from 0 to 60, although scores greater than or equal to 16 are considered high.
Time frame: From enrollment to 3-year follow-up
Population: Only patients with questionnaire data were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| H01: Medication | H02: Percentage of Patients With a Score of >= 16 on the Center for Epidemiological Studies Depression (CES-D) Scale | 4 Months | 29.6 percentage of participants |
| H01: Medication | H02: Percentage of Patients With a Score of >= 16 on the Center for Epidemiological Studies Depression (CES-D) Scale | 24 Months | 28.1 percentage of participants |
| H01: Medication | H02: Percentage of Patients With a Score of >= 16 on the Center for Epidemiological Studies Depression (CES-D) Scale | 12 Months | 24.4 percentage of participants |
| H01: Medication | H02: Percentage of Patients With a Score of >= 16 on the Center for Epidemiological Studies Depression (CES-D) Scale | 36 Months | 20.8 percentage of participants |
| H01: Medication | H02: Percentage of Patients With a Score of >= 16 on the Center for Epidemiological Studies Depression (CES-D) Scale | Baseline | 50.5 percentage of participants |
| H02: Medication+CABG+SVR | H02: Percentage of Patients With a Score of >= 16 on the Center for Epidemiological Studies Depression (CES-D) Scale | 36 Months | 24.8 percentage of participants |
| H02: Medication+CABG+SVR | H02: Percentage of Patients With a Score of >= 16 on the Center for Epidemiological Studies Depression (CES-D) Scale | Baseline | 53.2 percentage of participants |
| H02: Medication+CABG+SVR | H02: Percentage of Patients With a Score of >= 16 on the Center for Epidemiological Studies Depression (CES-D) Scale | 4 Months | 27.0 percentage of participants |
| H02: Medication+CABG+SVR | H02: Percentage of Patients With a Score of >= 16 on the Center for Epidemiological Studies Depression (CES-D) Scale | 12 Months | 27.0 percentage of participants |
| H02: Medication+CABG+SVR | H02: Percentage of Patients With a Score of >= 16 on the Center for Epidemiological Studies Depression (CES-D) Scale | 24 Months | 24.3 percentage of participants |
p-value: 0.4Chi-squared
p-value: 0.42Chi-squared
p-value: 0.41Chi-squared
p-value: 0.25Chi-squared
p-value: 0.25Chi-squared
Secondary
H02: Seattle Angina Questionnaire (SAQ) Anginal Frequency Subscale
These 2 items assess the frequency of chest pain over the last 4 weeks. Response choices range from 4 or more times a day (1) to None (6). The mean response is transformed to a 0-100 scale where higher scores reflect less frequent angina.
Time frame: From enrollment to 3-year follow-up
Population: Only patients with questionnaire data were analyzed.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| H01: Medication | H02: Seattle Angina Questionnaire (SAQ) Anginal Frequency Subscale | 4 Months | 100 units on a scale |
| H01: Medication | H02: Seattle Angina Questionnaire (SAQ) Anginal Frequency Subscale | 24 Months | 100 units on a scale |
| H01: Medication | H02: Seattle Angina Questionnaire (SAQ) Anginal Frequency Subscale | 12 Months | 100 units on a scale |
| H01: Medication | H02: Seattle Angina Questionnaire (SAQ) Anginal Frequency Subscale | 36 Months | 100 units on a scale |
| H01: Medication | H02: Seattle Angina Questionnaire (SAQ) Anginal Frequency Subscale | Baseline | 70 units on a scale |
| H02: Medication+CABG+SVR | H02: Seattle Angina Questionnaire (SAQ) Anginal Frequency Subscale | 36 Months | 100 units on a scale |
| H02: Medication+CABG+SVR | H02: Seattle Angina Questionnaire (SAQ) Anginal Frequency Subscale | Baseline | 80 units on a scale |
| H02: Medication+CABG+SVR | H02: Seattle Angina Questionnaire (SAQ) Anginal Frequency Subscale | 4 Months | 100 units on a scale |
| H02: Medication+CABG+SVR | H02: Seattle Angina Questionnaire (SAQ) Anginal Frequency Subscale | 12 Months | 100 units on a scale |
| H02: Medication+CABG+SVR | H02: Seattle Angina Questionnaire (SAQ) Anginal Frequency Subscale | 24 Months | 100 units on a scale |
p-value: 0.01Wilcoxon (Mann-Whitney)
p-value: 0.74Wilcoxon (Mann-Whitney)
p-value: 0.77Wilcoxon (Mann-Whitney)
p-value: 0.46Wilcoxon (Mann-Whitney)
p-value: 0.27Wilcoxon (Mann-Whitney)
Secondary
H02: Seattle Angina Questionnaire (SAQ) Anginal Stability Subscale
This item assesses the change in chest pain over the last 4 weeks. Response choices range from Much more often (1) to None (6). The mean response is transformed to a 0-100 scale where 50 represents no change and a higher score indicates less angina.
Time frame: From enrollment to 3-year follow-up
Population: Only patients with questionnaire data were analyzed.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| H01: Medication | H02: Seattle Angina Questionnaire (SAQ) Anginal Stability Subscale | 4 Months | 50 units on a scale |
| H01: Medication | H02: Seattle Angina Questionnaire (SAQ) Anginal Stability Subscale | 24 Months | 50 units on a scale |
| H01: Medication | H02: Seattle Angina Questionnaire (SAQ) Anginal Stability Subscale | 12 Months | 50 units on a scale |
| H01: Medication | H02: Seattle Angina Questionnaire (SAQ) Anginal Stability Subscale | 36 Months | 50 units on a scale |
| H01: Medication | H02: Seattle Angina Questionnaire (SAQ) Anginal Stability Subscale | Baseline | 50 units on a scale |
| H02: Medication+CABG+SVR | H02: Seattle Angina Questionnaire (SAQ) Anginal Stability Subscale | 36 Months | 50 units on a scale |
| H02: Medication+CABG+SVR | H02: Seattle Angina Questionnaire (SAQ) Anginal Stability Subscale | Baseline | 50 units on a scale |
| H02: Medication+CABG+SVR | H02: Seattle Angina Questionnaire (SAQ) Anginal Stability Subscale | 4 Months | 50 units on a scale |
| H02: Medication+CABG+SVR | H02: Seattle Angina Questionnaire (SAQ) Anginal Stability Subscale | 12 Months | 50 units on a scale |
| H02: Medication+CABG+SVR | H02: Seattle Angina Questionnaire (SAQ) Anginal Stability Subscale | 24 Months | 50 units on a scale |
p-value: 0.98Wilcoxon (Mann-Whitney)
p-value: 0.16Wilcoxon (Mann-Whitney)
p-value: 0.88Wilcoxon (Mann-Whitney)
p-value: 0.95Wilcoxon (Mann-Whitney)
p-value: 0.48Wilcoxon (Mann-Whitney)
Secondary
H02: Seattle Angina Questionnaire (SAQ) Quality-of-Life Subscale
These 3 items measure the patient's general satisfaction with life. Response choices range from 1 (least enjoyment) to 5 (high satisfaction). The mean score is transformed to a 0-100 scale where higher scores reflect better outcomes.
Time frame: From enrollment to 3-year follow-up
Population: Only patients with questionnaire data were analyzed.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| H01: Medication | H02: Seattle Angina Questionnaire (SAQ) Quality-of-Life Subscale | 4 Months | 83 units on a scale |
| H01: Medication | H02: Seattle Angina Questionnaire (SAQ) Quality-of-Life Subscale | 24 Months | 83 units on a scale |
| H01: Medication | H02: Seattle Angina Questionnaire (SAQ) Quality-of-Life Subscale | 12 Months | 83 units on a scale |
| H01: Medication | H02: Seattle Angina Questionnaire (SAQ) Quality-of-Life Subscale | 36 Months | 83 units on a scale |
| H01: Medication | H02: Seattle Angina Questionnaire (SAQ) Quality-of-Life Subscale | Baseline | 42 units on a scale |
| H02: Medication+CABG+SVR | H02: Seattle Angina Questionnaire (SAQ) Quality-of-Life Subscale | 36 Months | 83 units on a scale |
| H02: Medication+CABG+SVR | H02: Seattle Angina Questionnaire (SAQ) Quality-of-Life Subscale | Baseline | 42 units on a scale |
| H02: Medication+CABG+SVR | H02: Seattle Angina Questionnaire (SAQ) Quality-of-Life Subscale | 4 Months | 83 units on a scale |
| H02: Medication+CABG+SVR | H02: Seattle Angina Questionnaire (SAQ) Quality-of-Life Subscale | 12 Months | 83 units on a scale |
| H02: Medication+CABG+SVR | H02: Seattle Angina Questionnaire (SAQ) Quality-of-Life Subscale | 24 Months | 83 units on a scale |
p-value: 0.86Wilcoxon (Mann-Whitney)
p-value: 0.39Wilcoxon (Mann-Whitney)
p-value: 0.65Wilcoxon (Mann-Whitney)
p-value: 0.15Wilcoxon (Mann-Whitney)
p-value: 0.68Wilcoxon (Mann-Whitney)
Secondary
H02: SF-12 Mental Component Summary (MCS) Scale
Twelve items that reflect both physical and mental health are selected from the SF-36 subscales and combined according to an algebraic formula using published weights and constants: (a) First, the items are coded so that a higher value indicates better health; (b) then indicator variables (1/0) are created for the item response choice categories; (c) next, the 35 indicator variables are weighted using mental regression weights from the general US population and summed to produce the MCS-12 score; and (d) finally, a normalized score (with a mean of 50 and standard deviation of 10) is obtained by adding the mental constant from the scoring table to the sum of the 35 products.
Time frame: From enrollment to 3-year follow-up
Population: Only patients with questionnaire data were analyzed.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| H01: Medication | H02: SF-12 Mental Component Summary (MCS) Scale | 4 Months | 54 units on a scale |
| H01: Medication | H02: SF-12 Mental Component Summary (MCS) Scale | 24 Months | 56 units on a scale |
| H01: Medication | H02: SF-12 Mental Component Summary (MCS) Scale | 12 Months | 57 units on a scale |
| H01: Medication | H02: SF-12 Mental Component Summary (MCS) Scale | 36 Months | 56 units on a scale |
| H01: Medication | H02: SF-12 Mental Component Summary (MCS) Scale | Baseline | 42 units on a scale |
| H02: Medication+CABG+SVR | H02: SF-12 Mental Component Summary (MCS) Scale | 36 Months | 56 units on a scale |
| H02: Medication+CABG+SVR | H02: SF-12 Mental Component Summary (MCS) Scale | Baseline | 41 units on a scale |
| H02: Medication+CABG+SVR | H02: SF-12 Mental Component Summary (MCS) Scale | 4 Months | 55 units on a scale |
| H02: Medication+CABG+SVR | H02: SF-12 Mental Component Summary (MCS) Scale | 12 Months | 54 units on a scale |
| H02: Medication+CABG+SVR | H02: SF-12 Mental Component Summary (MCS) Scale | 24 Months | 55 units on a scale |
p-value: 0.74Wilcoxon (Mann-Whitney)
p-value: 0.87Wilcoxon (Mann-Whitney)
p-value: 0.03Wilcoxon (Mann-Whitney)
p-value: 0.6Wilcoxon (Mann-Whitney)
p-value: 0.87Wilcoxon (Mann-Whitney)
Secondary
H02: SF-12 Physical Component Summary (PCS) Scale
Twelve items that reflect both physical and mental health are selected from the SF-36 subscales and combined according to an algebraic formula using published weights and constants: (a) First, the items are coded so that a higher value indicates better health; (b) then indicator variables (1/0) are created for the item response choice categories; (c) next, the 35 indicator variables are weighted using physical regression weights from the general US population and summed to produce the PCS-12 score; and (d) finally, a normalized score (with a mean of 50 and standard deviation of 10) is obtained by adding the physical constant from the scoring table to the sum of the 35 products.
Time frame: From enrollment to 3-year follow-up
Population: Only patients with questionnaire data were analyzed.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| H01: Medication | H02: SF-12 Physical Component Summary (PCS) Scale | 4 Months | 40 units on a scale |
| H01: Medication | H02: SF-12 Physical Component Summary (PCS) Scale | 24 Months | 41 units on a scale |
| H01: Medication | H02: SF-12 Physical Component Summary (PCS) Scale | 12 Months | 41 units on a scale |
| H01: Medication | H02: SF-12 Physical Component Summary (PCS) Scale | 36 Months | 40 units on a scale |
| H01: Medication | H02: SF-12 Physical Component Summary (PCS) Scale | Baseline | 37 units on a scale |
| H02: Medication+CABG+SVR | H02: SF-12 Physical Component Summary (PCS) Scale | 36 Months | 41 units on a scale |
| H02: Medication+CABG+SVR | H02: SF-12 Physical Component Summary (PCS) Scale | Baseline | 37 units on a scale |
| H02: Medication+CABG+SVR | H02: SF-12 Physical Component Summary (PCS) Scale | 4 Months | 40 units on a scale |
| H02: Medication+CABG+SVR | H02: SF-12 Physical Component Summary (PCS) Scale | 12 Months | 41 units on a scale |
| H02: Medication+CABG+SVR | H02: SF-12 Physical Component Summary (PCS) Scale | 24 Months | 41 units on a scale |
p-value: 0.71Wilcoxon (Mann-Whitney)
p-value: 0.57Wilcoxon (Mann-Whitney)
p-value: 0.15Wilcoxon (Mann-Whitney)
p-value: 0.64Wilcoxon (Mann-Whitney)
p-value: 0.07Wilcoxon (Mann-Whitney)
Secondary
H02: SF-36 Mental Health Subscale
These 5 items assess anxiety, depression, emotional control, and psychological well-being. Response choices range from All of the time (1) to None of the time (6). Item values are summed and then transformed to a 0-100 scale where higher scores indicate better mental health. (Final scores are normalized to a mean of 50 and standard deviation of 10.)
Time frame: From enrollment to 3-year follow-up
Population: Only patients with questionnaire data were analyzed.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| H01: Medication | H02: SF-36 Mental Health Subscale | 4 Months | 50 units on a scale |
| H01: Medication | H02: SF-36 Mental Health Subscale | 24 Months | 50 units on a scale |
| H01: Medication | H02: SF-36 Mental Health Subscale | 12 Months | 53 units on a scale |
| H01: Medication | H02: SF-36 Mental Health Subscale | 36 Months | 50 units on a scale |
| H01: Medication | H02: SF-36 Mental Health Subscale | Baseline | 41 units on a scale |
| H02: Medication+CABG+SVR | H02: SF-36 Mental Health Subscale | 36 Months | 50 units on a scale |
| H02: Medication+CABG+SVR | H02: SF-36 Mental Health Subscale | Baseline | 41 units on a scale |
| H02: Medication+CABG+SVR | H02: SF-36 Mental Health Subscale | 4 Months | 50 units on a scale |
| H02: Medication+CABG+SVR | H02: SF-36 Mental Health Subscale | 12 Months | 50 units on a scale |
| H02: Medication+CABG+SVR | H02: SF-36 Mental Health Subscale | 24 Months | 50 units on a scale |
p-value: 0.91Wilcoxon (Mann-Whitney)
p-value: 0.62Wilcoxon (Mann-Whitney)
p-value: 0.04Wilcoxon (Mann-Whitney)
p-value: 0.96Wilcoxon (Mann-Whitney)
p-value: 0.78Wilcoxon (Mann-Whitney)
Secondary
H02: SF-36 Role Emotional Subscale
These 3 items assess limitations and difficulty performing work or other usual activities as a result of any emotional problems (such as feeling depressed or anxious). Response choices are either Yes (1) or No (2). Item values are summed and then transformed to a 0-100 scale where higher scores indicate better outcomes. (Final scores are normalized to a mean of 50 and standard deviation of 10.)
Time frame: From enrollment to 3-year follow-up
Population: Only patients with questionnaire data were analyzed.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| H01: Medication | H02: SF-36 Role Emotional Subscale | 4 Months | 55 units on a scale |
| H01: Medication | H02: SF-36 Role Emotional Subscale | 24 Months | 55 units on a scale |
| H01: Medication | H02: SF-36 Role Emotional Subscale | 12 Months | 55 units on a scale |
| H01: Medication | H02: SF-36 Role Emotional Subscale | 36 Months | 55 units on a scale |
| H01: Medication | H02: SF-36 Role Emotional Subscale | Baseline | 34 units on a scale |
| H02: Medication+CABG+SVR | H02: SF-36 Role Emotional Subscale | 36 Months | 55 units on a scale |
| H02: Medication+CABG+SVR | H02: SF-36 Role Emotional Subscale | Baseline | 34 units on a scale |
| H02: Medication+CABG+SVR | H02: SF-36 Role Emotional Subscale | 4 Months | 55 units on a scale |
| H02: Medication+CABG+SVR | H02: SF-36 Role Emotional Subscale | 12 Months | 55 units on a scale |
| H02: Medication+CABG+SVR | H02: SF-36 Role Emotional Subscale | 24 Months | 55 units on a scale |
p-value: 0.82Wilcoxon (Mann-Whitney)
p-value: 0.48Wilcoxon (Mann-Whitney)
p-value: 0.69Wilcoxon (Mann-Whitney)
p-value: 0.63Wilcoxon (Mann-Whitney)
p-value: 0.9Wilcoxon (Mann-Whitney)
Secondary
H02: SF-36 Role Physical Subscale
These 4 items assess limitations and difficulty performing work or other usual activities as a result of one's physical health. Response choices are either Yes (1) or No (2). Item values are summed and then transformed to a 0-100 scale where higher scores indicate better outcomes. (Final scores are normalized to a mean of 50 and standard deviation of 10.)
Time frame: From enrollment to 3-year follow-up
Population: Only patients with questionnaire data were analyzed.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| H01: Medication | H02: SF-36 Role Physical Subscale | 4 Months | 42 units on a scale |
| H01: Medication | H02: SF-36 Role Physical Subscale | 24 Months | 49 units on a scale |
| H01: Medication | H02: SF-36 Role Physical Subscale | 12 Months | 49 units on a scale |
| H01: Medication | H02: SF-36 Role Physical Subscale | 36 Months | 49 units on a scale |
| H01: Medication | H02: SF-36 Role Physical Subscale | Baseline | 28 units on a scale |
| H02: Medication+CABG+SVR | H02: SF-36 Role Physical Subscale | 36 Months | 56 units on a scale |
| H02: Medication+CABG+SVR | H02: SF-36 Role Physical Subscale | Baseline | 28 units on a scale |
| H02: Medication+CABG+SVR | H02: SF-36 Role Physical Subscale | 4 Months | 42 units on a scale |
| H02: Medication+CABG+SVR | H02: SF-36 Role Physical Subscale | 12 Months | 49 units on a scale |
| H02: Medication+CABG+SVR | H02: SF-36 Role Physical Subscale | 24 Months | 49 units on a scale |
p-value: 0.74Wilcoxon (Mann-Whitney)
p-value: 0.61Wilcoxon (Mann-Whitney)
p-value: 0.78Wilcoxon (Mann-Whitney)
p-value: 0.94Wilcoxon (Mann-Whitney)
p-value: 0.29Wilcoxon (Mann-Whitney)
Secondary
H02: SF-36 Social Functioning Subscale
These 2 items assess the limitations on social activities with others. Response choices range from Extremely or All of the time (1) to Not at all or None of the time (5). Item values are summed and then transformed to a 0-100 scale where higher scores indicate better social functioning. (Final scores are normalized to a mean of 50 and standard deviation of 10.)
Time frame: From enrollment to 3-year follow-up
Population: Only patients with questionnaire data were analyzed.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| H01: Medication | H02: SF-36 Social Functioning Subscale | 4 Months | 52 units on a scale |
| H01: Medication | H02: SF-36 Social Functioning Subscale | 24 Months | 52 units on a scale |
| H01: Medication | H02: SF-36 Social Functioning Subscale | 12 Months | 52 units on a scale |
| H01: Medication | H02: SF-36 Social Functioning Subscale | 36 Months | 52 units on a scale |
| H01: Medication | H02: SF-36 Social Functioning Subscale | Baseline | 41 units on a scale |
| H02: Medication+CABG+SVR | H02: SF-36 Social Functioning Subscale | 36 Months | 52 units on a scale |
| H02: Medication+CABG+SVR | H02: SF-36 Social Functioning Subscale | Baseline | 35 units on a scale |
| H02: Medication+CABG+SVR | H02: SF-36 Social Functioning Subscale | 4 Months | 52 units on a scale |
| H02: Medication+CABG+SVR | H02: SF-36 Social Functioning Subscale | 12 Months | 52 units on a scale |
| H02: Medication+CABG+SVR | H02: SF-36 Social Functioning Subscale | 24 Months | 52 units on a scale |
p-value: 0.36Wilcoxon (Mann-Whitney)
p-value: 0.87Wilcoxon (Mann-Whitney)
p-value: 0.17Wilcoxon (Mann-Whitney)
p-value: 0.12Wilcoxon (Mann-Whitney)
p-value: 0.79Wilcoxon (Mann-Whitney)
Secondary
H02: SF-36 Vitality Subscale
These 4 items assess energy level and fatigue. Response choices range from All of the time (1) to None of the time (6). Item values are summed and then transformed to a 0-100 scale where higher scores indicate better vitality. (Final scores are normalized to a mean of 50 and standard deviation of 10.)
Time frame: From enrollment to 3-year follow-up
Population: Only patients with questionnaire data were analyzed.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| H01: Medication | H02: SF-36 Vitality Subscale | 4 Months | 51 units on a scale |
| H01: Medication | H02: SF-36 Vitality Subscale | 24 Months | 51 units on a scale |
| H01: Medication | H02: SF-36 Vitality Subscale | 12 Months | 53 units on a scale |
| H01: Medication | H02: SF-36 Vitality Subscale | 36 Months | 51 units on a scale |
| H01: Medication | H02: SF-36 Vitality Subscale | Baseline | 44 units on a scale |
| H02: Medication+CABG+SVR | H02: SF-36 Vitality Subscale | 36 Months | 51 units on a scale |
| H02: Medication+CABG+SVR | H02: SF-36 Vitality Subscale | Baseline | 44 units on a scale |
| H02: Medication+CABG+SVR | H02: SF-36 Vitality Subscale | 4 Months | 51 units on a scale |
| H02: Medication+CABG+SVR | H02: SF-36 Vitality Subscale | 12 Months | 51 units on a scale |
| H02: Medication+CABG+SVR | H02: SF-36 Vitality Subscale | 24 Months | 51 units on a scale |
p-value: 0.31Wilcoxon (Mann-Whitney)
p-value: 0.42Wilcoxon (Mann-Whitney)
p-value: 0.66Wilcoxon (Mann-Whitney)
p-value: 0.32Wilcoxon (Mann-Whitney)
p-value: 0.43Wilcoxon (Mann-Whitney)
Secondary
H02: Stroke
Time frame: 5 years post randomization
Population: The Total H02: Medication + CABG group includes the H02: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| H01: Medication | H02: Stroke | 31 participants |
| H02: Medication+CABG+SVR | H02: Stroke | 23 participants |