Coronary Artery Disease
Conditions
Keywords
Hybrid Coronary Revascularization, Coronary Artery Bypass Grafting, Percutaneous Coronary Intervention
Brief summary
The purpose of the study is to learn which treatment option is better for patients who have multi-vessel coronary artery disease (blockages in more than one vessel supplying blood to the heart muscle). The treatment options this study will compare are: (1) Hybrid Coronary Revascularization \[HCR\] (a combination of surgery and catheter procedures to open up clogged heart arteries) and (2) Percutaneous Coronary Intervention \[PCI\] (catheter procedures alone to open up clogged heart arteries). There are no new or experimental procedures being tested in this study: both HCR and PCI are well-established procedures and are regularly performed in patients who have coronary artery disease. But, the FDA has not approved the drug-eluting stents used in PCI for all types of coronary artery disease. We have received an Investigational Device Exemption from the FDA to use the drug-eluting stents in this trial in the same way that they are used in clinical practice. The study being proposed here will use rigorous scientific methods and should result in a very high level of certainty about which procedure is best for patients with coronary artery disease.
Detailed description
The increasing prevalence of coronary artery disease (CAD), advances in coronary artery bypass grafting (CABG), percutaneous coronary intervention (PCI), and concomitant medical therapy, and the costs of revascularization have resulted in rising interest regarding the appropriate indications and alternatives for coronary revascularization. Hybrid coronary revascularization is the intended combination of CABG and PCI. The HCR strategy combines grafting of the left anterior descending artery (LAD) coronary artery using the left internal mammary artery (LIMA) and PCI of non-LAD coronary stenoses. Essentially, stents are substituted for saphenous vein grafts (SVG) for non-LAD lesions, and the surgical LIMA to LAD bypass is performed, ideally through a limited access, minimally traumatic approach. Unfortunately, the published data to date on HCR must be considered limited and hypothesis generating. Clinicians, payers, and patients are interested in the specific benefits of revascularization alternatives. HCR as a scientifically validated approach would have a major healthcare impact. The ability to deliver a new therapy for CAD that provides durability, but without the obligatory trauma and prolonged recovery time characteristic of conventional CABG would be a major advance in the field of cardiovascular medicine. The NHLBI-funded Hybrid Observational Study demonstrated that equipoise exists between the two coronary revascularization paradigms; however, a rigorously designed randomized clinical trial is now needed to provide sufficient evidence to guide clinical decision making for this important patient population. This trial is a prospective, multi-center randomized comparative effectiveness trial of HCR compared to multi-vessel PCI in patients with multi-vessel CAD involving the LAD or left main (LM) territories. The trial is designed as a large, simple trial, and some baseline, procedure-related and short-term outcomes data collection will be extracted from existing registry data (Society of Thoracic Surgeons \[STS\] Data Registry). The overall objective of this trial is to evaluate the effectiveness and safety of Hybrid Coronary Revascularization (HCR) compared to multi-vessel PCI with drug-eluting stents (DES) in patients with multi-vessel coronary artery disease involving the Left Main and/or Left Anterior Descending arteries. The primary objective the trial is to determine whether hybrid coronary revascularization is associated with a reduction in Major Adverse Cardiac and Cerebrovascular Events (MACCE) compared to PCI with DES. The secondary objectives are to determine the impact of HCR compared to PCI on health status and quality of life.
Interventions
PROCEDUREHybrid Coronary Revascularization (isolated LIMA-LAD)
sternal-sparing, off-pump, isolated LIMA-LAD revascularization
DEVICEHybrid Coronary Revascularization (PCI)
percutaneous revascularization of at least one non-LAD target
DEVICEPercutaneous Coronary Intervention
Multi-vessel PCI with metallic drug-eluting stents (DES) including the LAD and or LM. Only FDA approved commercially available metallic drug-eluting stents may be used in this protocol.
Sponsors
National Heart, Lung, and Blood Institute (NHLBI)
Emilia Bagiella
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
The DCC Research Coordinator will be blinded to treatment assignment during follow-up telephone calls and will be blinded to aggregate outcomes data.
Intervention model description
This trial is a prospective, multi-center randomized comparative effectiveness trial of HCR compared to multi-vessel PCI with metallic DES in patients with multi-vessel CAD involving the LAD or LM territories.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Signed informed consent, inclusive of release of medical information, and Health Insurance Portability and Accountability Act (HIPAA) documentation (US sites) * Age ≥ 18 years * Clinical indication for coronary revascularization * Coronary anatomy requiring revascularization as follows(2) * Multivessel CAD involving the LAD (proximal or mid) and/or LM (ostial, mid-shaft or distal) with at least 1 other epicardial coronary artery requiring treatment (LCX or RCA), OR * Single vessel disease involving the LAD and a major diagonal, with both requiring independent revascularization with at least one stent if randomized to HCR and stents for both the LAD and diagonal if randomized to multivessel PCI Note: If the patient qualifies based only on a LM lesion, then there must be involvement of the distal bifurcation (Medina 1,1,1) intended for treatment with a 2-stent approach (separate stents into the LAD and LCX) if randomized to PCI. However, if the patient also has non-LM disease in the RCA and/or non-ostial LAD and/or non-ostial LCX that requires separate treatment, any LM lesion is a valid criterion for enrollment, whether LM ostial, shaft or distal bifurcation disease, and any strategy of treating the LM may be employed, including not treating the ostial LCX, a provisional approach or a planned 2-stent strategy as appropriate. Similarly, if the patient qualifies based only on LAD-Dg disease, whether a bifurcation lesion or separate lesions in the LAD and Dg, without RCA or LCX disease, then both the LAD and Dg must be true lesions intended for stents (planned 2-stent approach). However, if the patient has LAD-Dg disease and a lesion in the RCA or LCX that also requires treatment, the LAD-Dg disease can then be treated in any fashion (2-stents, a provisional approach, or the Dg not even dilated if it is small), according to operator preference * Suitable candidate for both PCI with metallic DES and HCR as determined by clinical assessment and angiogram review by an interventional cardiologist and a cardiac surgeon at the enrolling clinical site * Ability to tolerate and no plans to interrupt dual anti-platelet therapy for ≥ 6 months if presentation with stable CAD, or ≥ 12 months if presentation with biomarker positive acute coronary syndrome (ACS) * Willing to comply with all protocol required follow-up
Exclusion criteria
* Previous cardiac surgery of any kind, including CABG * Previous thoracic surgery involving the left pleural space * Previous LM or LAD stent (a) with evidence of in-stent restenosis or (b) within 1 cm of a qualifying lesion * Previous PCI of the LM and/or LAD within 12 months prior to randomization * PCI with bare metal stent (BMS) within 12 months prior to randomization * Any complication or unsuccessful revascularization with PCI within 30 days prior to randomization. Note: A patient may be considered eligible for enrollment if PCI with DES in non-LM and non-LAD territory was performed within 30 days prior to randomization, as long as revascularization was successful and uncomplicated, or has been performed more than 30 days prior even if unsuccessful or complicated * Planned treatment with bioresorbable vascular scaffold(s) after randomization * Total occlusion (TIMI 0 or 1 flow) of the LM, LAD or LCX. * Cardiogenic shock at time of screening * STEMI within 72 hours prior to randomization * Need for concomitant vascular or other cardiac surgery during the index hospitalization (including, but not limited to, valve surgery, aortic resection, left ventricular aneurysmectomy, and carotid endarterectomy or stenting) * Indication for chronic oral anticoagulation therapy at the time of randomization * Any prior lung resection * End-Stage Renal Disease (ESRD) on dialysis * Patients who could not be switched from prasugrel or ticagrelor to clopidogrel, should that be needed prior to a CABG, during reverse HCR * Extra-cardiac illness that is expected to limit survival to less than 5 years * Allergy or hypersensitivity to any of the study drugs or devices used in the trial * Therapy with an investigational drug, device or biologic within 1 year prior to randomization, or plan to enroll patient in additional investigational study during participation in this trial * Unable to give informed consent or potential for noncompliance with the study protocol in the judgment of the investigator * Pregnant at time of screening or unwilling to use effective birth control measures while dual antiplatelet therapy is required.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Major Adverse Coronary and Cerebrovascular Events (MACCE) | Up to 24 months | The current sample size of 200 patients will not provide sufficient power to test the original null hypothesis of the trial. However, it will allow for an estimate of the MACCE rate in the two groups. A 2-year follow-up will be used to capture and understand the difference in MACCE between the two procedures. This reasoning is based on the NHLBI-funded Hybrid Revascularization Observational Study (ClinicalTrials.gov Identifier NCT01121263), which enrolled 200 HCR and 98 multi-vessel PCI with drug-eluting stent (DES) patients, and demonstrated similar risk-adjusted MACCE rates over the first 12 months following the intervention but divergence by approximately 18 months of followup. Therefore, it is important to continue the follow-up of the 200 randomized patients to at least 24 months. Of note, some patients who were enrolled early in the trial will have up to 3 years of follow-up data collected by the time the final patient randomized completes the 2-year time point. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Creatinine Levels | Up to 90 days post-randomization | For HCR patients, lab values are pre- and post-CABG. For PCI patients, lab values are pre- and post- the last PCI. |
| CK-MB Levels (ng/dL) | Up to 90 days post-randomization | For HCR patients, lab values are pre- and post-CABG. For PCI patients, lab values are pre- and post- the last PCI. |
| CK-MB Levels (IU/L) | Up to 90 days post-randomization | For HCR patients, lab values are pre- and post-CABG. For PCI patients, lab values are pre- and post- the last PCI. |
| Troponin Levels | Up to 90 days post-randomization | For HCR patients, lab values are pre- and post-CABG. For PCI patients, lab values are pre- and post- the last PCI. |
| Number of Participants Requiring Medications | 24 Hours Prior to, During, and Within 24 Hours of the Procedure | For HCR patients, medications are prior/during/after CABG. For PCI patients, medications are prior/during/after the last PCI. Number of participants requiring medications at any time 24 Hours Prior to, During, and Within 24 Hours of the Procedure. Procedures can occur up to 90 days after randomization. |
| Hemoglobin Levels | Up to 90 days post-randomization | For HCR patients, lab values are pre- and post-CABG. For PCI patients, lab values are pre- and post- the last PCI. |
| Length of Stay | Up to 90 days post-randomization | Length of stay for all study procedures combined, beginning at date of procedure |
| Discharge Disposition | Up to 90 days post-randomization | Discharge disposition is for the last study procedure |
| Cost-Effectiveness | Up to 24 months | Health Status as measured by cost-effectiveness. Cost-effectiveness will be evaluated using a micro-simulation model, which will predict the accrued health care costs and quality-adjusted life expectancy for each subject at the end of the trial follow-up period and in addition over a lifetime horizon. |
| Feasibility of Incorporating Registry Data in a Randomized Clinical Trial | Up to 24 months | For the HCR group, partial data will be extracted and transferred from the STS registry. Thus, this study will also allow evaluation of the process of data transfer, assessment of the data quality, and eventually determination of the feasibility to conduct a clinical trial with data linked to a registry. |
| Number of Participants Requiring Transfusion | Up to 90 days post-randomization | Number of participants requiring transfusion during procedure and after procedure |
Countries
Canada, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Hybrid Coronary Revascularization Group HCR is defined, for the purposes of this trial, as a planned off-pump minimally invasive (sternal-sparing), isolated LIMA-LAD revascularization, combined with percutaneous revascularization of at least one non-LAD target.
Hybrid Coronary Revascularization (isolated LIMA-LAD): sternal-sparing, off-pump, isolated LIMA-LAD revascularization
Hybrid Coronary Revascularization (PCI): percutaneous revascularization of at least one non-LAD target | 88 |
| Percutaneous Coronary Intervention PCI will be performed using standard techniques at the discretion of the operator. Only Food and Drug Administration (FDA) and Health Canada approved commercially available metallic drug-eluting stents may be used in this protocol.
Percutaneous Coronary Intervention: Multi-vessel PCI with metallic drug-eluting stents (DES) including the LAD and or LM. Only FDA approved commercially available metallic drug-eluting stents may be used in this protocol. | 112 |
| Total | 200 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 4 | 9 |
| Overall Study | Lost to Follow-up | 21 | 30 |
| Overall Study | Withdrawal by Subject | 2 | 2 |
Baseline characteristics
| Characteristic | Percutaneous Coronary Intervention | Total | Hybrid Coronary Revascularization Group |
|---|---|---|---|
| Age, Continuous | 66.8 years STANDARD_DEVIATION 9.2 | 65.3 years STANDARD_DEVIATION 9.2 | 63.3 years STANDARD_DEVIATION 8.8 |
| Angina Class - CCSC Grade I | 17 Participants | 28 Participants | 11 Participants |
| Angina Class - CCSC Grade II | 22 Participants | 41 Participants | 19 Participants |
| Angina Class - CCSC Grade III | 30 Participants | 57 Participants | 27 Participants |
| Angina Class - CCSC Grade IV | 16 Participants | 21 Participants | 5 Participants |
| Angina Class - CCSC No Angina | 27 Participants | 53 Participants | 26 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 22 Participants | 44 Participants | 22 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 84 Participants | 150 Participants | 66 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 6 Participants | 6 Participants | 0 Participants |
| Euroqol Health Rating | 75.0 units on a scale | 75.0 units on a scale | 75.0 units on a scale |
| New York Heart Association (NYHA) Classification Class I | 23 Participants | 41 Participants | 18 Participants |
| New York Heart Association (NYHA) Classification Class II | 28 Participants | 48 Participants | 20 Participants |
| New York Heart Association (NYHA) Classification Class III | 13 Participants | 18 Participants | 5 Participants |
| New York Heart Association (NYHA) Classification Class IV | 5 Participants | 10 Participants | 5 Participants |
| New York Heart Association (NYHA) Classification No Heart Failure | 41 Participants | 79 Participants | 38 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 6 Participants | 10 Participants | 4 Participants |
| Race (NIH/OMB) Black or African American | 15 Participants | 27 Participants | 12 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 12 Participants | 17 Participants | 5 Participants |
| Race (NIH/OMB) White | 78 Participants | 145 Participants | 67 Participants |
| Risk Factors Arrhythmia | 6 Participants | 13 Participants | 7 Participants |
| Risk Factors Cerebrovascular Disease | 5 Participants | 16 Participants | 11 Participants |
| Risk Factors Diabetes | 54 Participants | 104 Participants | 50 Participants |
| Risk Factors Dialysis | 2 Participants | 3 Participants | 1 Participants |
| Risk Factors Dyslipidemia | 88 Participants | 165 Participants | 77 Participants |
| Risk Factors Heart Failure | 25 Participants | 35 Participants | 10 Participants |
| Risk Factors Hypertension | 99 Participants | 171 Participants | 72 Participants |
| Risk Factors Immunocompromise Present | 3 Participants | 8 Participants | 5 Participants |
| Risk Factors Liver Disease | 2 Participants | 7 Participants | 5 Participants |
| Risk Factors Lung Disease | 12 Participants | 25 Participants | 13 Participants |
| Risk Factors Peripheral Artery Disease | 5 Participants | 9 Participants | 4 Participants |
| Risk Factors Previous MI | 42 Participants | 76 Participants | 34 Participants |
| Risk Factors Previous PCI | 44 Participants | 81 Participants | 37 Participants |
| Risk Factors Tobacco Use | 10 Participants | 29 Participants | 19 Participants |
| Sex: Female, Male Female | 36 Participants | 61 Participants | 25 Participants |
| Sex: Female, Male Male | 76 Participants | 139 Participants | 63 Participants |
| SF-12 Score Mental Health Composite Score | 54.0 units on a scale | 53.9 units on a scale | 53.6 units on a scale |
| SF-12 Score Physical Health Composite Score | 42.4 units on a scale | 41.7 units on a scale | 41.5 units on a scale |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 4 / 88 | 9 / 112 |
| other Total, other adverse events | 18 / 88 | 9 / 112 |
| serious Total, serious adverse events | 20 / 88 | 11 / 112 |
Outcome results
Primary
Major Adverse Coronary and Cerebrovascular Events (MACCE)
The current sample size of 200 patients will not provide sufficient power to test the original null hypothesis of the trial. However, it will allow for an estimate of the MACCE rate in the two groups. A 2-year follow-up will be used to capture and understand the difference in MACCE between the two procedures. This reasoning is based on the NHLBI-funded Hybrid Revascularization Observational Study (ClinicalTrials.gov Identifier NCT01121263), which enrolled 200 HCR and 98 multi-vessel PCI with drug-eluting stent (DES) patients, and demonstrated similar risk-adjusted MACCE rates over the first 12 months following the intervention but divergence by approximately 18 months of followup. Therefore, it is important to continue the follow-up of the 200 randomized patients to at least 24 months. Of note, some patients who were enrolled early in the trial will have up to 3 years of follow-up data collected by the time the final patient randomized completes the 2-year time point.
Time frame: Up to 24 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Hybrid Coronary Revascularization Group | Major Adverse Coronary and Cerebrovascular Events (MACCE) | 0.130 MACCE Event Rate per Person-Year |
| Percutaneous Coronary Intervention | Major Adverse Coronary and Cerebrovascular Events (MACCE) | 0.111 MACCE Event Rate per Person-Year |
Secondary
CK-MB Levels (IU/L)
For HCR patients, lab values are pre- and post-CABG. For PCI patients, lab values are pre- and post- the last PCI.
Time frame: Up to 90 days post-randomization
Population: The overall analysis population represents the number of patients who contributed to at least one of the pre/post measurements. Patients randomized to the HCR arm and received PCI only OR patients randomized to the PCI arm and received CABG are not included. Most patients switched interventions due to their preference. Patients who did not receive any procedures are also excluded. Patients received no interventions due to physician decision or early termination (withdrawal or lost to follow-up).
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Hybrid Coronary Revascularization Group | CK-MB Levels (IU/L) | Pre-Procedure | 72.00 IU/L |
| Hybrid Coronary Revascularization Group | CK-MB Levels (IU/L) | Post-Procedure | 311.00 IU/L |
| Percutaneous Coronary Intervention | CK-MB Levels (IU/L) | Pre-Procedure | 62.00 IU/L |
| Percutaneous Coronary Intervention | CK-MB Levels (IU/L) | Post-Procedure | 77.00 IU/L |
Secondary
CK-MB Levels (ng/dL)
For HCR patients, lab values are pre- and post-CABG. For PCI patients, lab values are pre- and post- the last PCI.
Time frame: Up to 90 days post-randomization
Population: The overall analysis population represents the number of patients who contributed to at least one of the pre/post measurements. Patients randomized to the HCR arm and received PCI only OR patients randomized to the PCI arm and received CABG are not included. Most patients switched interventions due to their preference. Patients who did not receive any procedures are also excluded. Patients received no interventions due to physician decision or early termination (withdrawal or lost to follow-up).
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Hybrid Coronary Revascularization Group | CK-MB Levels (ng/dL) | Pre-Procedure | 0.90 ng/dL |
| Hybrid Coronary Revascularization Group | CK-MB Levels (ng/dL) | Post-Procedure | 2.79 ng/dL |
| Percutaneous Coronary Intervention | CK-MB Levels (ng/dL) | Pre-Procedure | 1.80 ng/dL |
| Percutaneous Coronary Intervention | CK-MB Levels (ng/dL) | Post-Procedure | 3.75 ng/dL |
Secondary
Cost-Effectiveness
Health Status as measured by cost-effectiveness. Cost-effectiveness will be evaluated using a micro-simulation model, which will predict the accrued health care costs and quality-adjusted life expectancy for each subject at the end of the trial follow-up period and in addition over a lifetime horizon.
Time frame: Up to 24 months
Population: While quality of life data was collected, they are not usable in a cost-effectiveness analysis due to the reduced sample size and reduced follow-up. In addition, since the trial was halted prematurely, cost data was not collected. Therefore, a cost-effectiveness analysis is not feasible.
Secondary
Creatinine Levels
For HCR patients, lab values are pre- and post-CABG. For PCI patients, lab values are pre- and post- the last PCI.
Time frame: Up to 90 days post-randomization
Population: The overall analysis population represents the number of patients who contributed to at least one of the pre/post measurements. Patients randomized to the HCR arm and received PCI only OR patients randomized to the PCI arm and received CABG are not included. Most patients switched interventions due to their preference. Patients who did not receive any procedures are also excluded. Patients received no interventions due to physician decision or early termination (withdrawal or lost to follow-up).
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Hybrid Coronary Revascularization Group | Creatinine Levels | Pre-Procedure | 0.95 mg/dL |
| Hybrid Coronary Revascularization Group | Creatinine Levels | Post-Procedure | 1.03 mg/dL |
| Percutaneous Coronary Intervention | Creatinine Levels | Pre-Procedure | 0.95 mg/dL |
| Percutaneous Coronary Intervention | Creatinine Levels | Post-Procedure | 0.93 mg/dL |
Secondary
Discharge Disposition
Discharge disposition is for the last study procedure
Time frame: Up to 90 days post-randomization
Population: Patients with at least one post-randomization procedure are included. Additional patients are missing data on discharge disposition.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Hybrid Coronary Revascularization Group | Discharge Disposition | Home | 76 Participants |
| Hybrid Coronary Revascularization Group | Discharge Disposition | Nursing Home | 1 Participants |
| Hybrid Coronary Revascularization Group | Discharge Disposition | Extended Care/Transitional Care Unit/Rehab | 5 Participants |
| Hybrid Coronary Revascularization Group | Discharge Disposition | Other | 1 Participants |
| Hybrid Coronary Revascularization Group | Discharge Disposition | Other Acute Care Hospital | 0 Participants |
| Percutaneous Coronary Intervention | Discharge Disposition | Other | 0 Participants |
| Percutaneous Coronary Intervention | Discharge Disposition | Other Acute Care Hospital | 1 Participants |
| Percutaneous Coronary Intervention | Discharge Disposition | Home | 105 Participants |
| Percutaneous Coronary Intervention | Discharge Disposition | Extended Care/Transitional Care Unit/Rehab | 3 Participants |
| Percutaneous Coronary Intervention | Discharge Disposition | Nursing Home | 0 Participants |
Secondary
Feasibility of Incorporating Registry Data in a Randomized Clinical Trial
For the HCR group, partial data will be extracted and transferred from the STS registry. Thus, this study will also allow evaluation of the process of data transfer, assessment of the data quality, and eventually determination of the feasibility to conduct a clinical trial with data linked to a registry.
Time frame: Up to 24 months
Population: HCR: Obtaining data from the STS registry was not straightforward and was related to difficulty in obtaining the data and linking all clinical trial patients with their STS data. In general, more work needs to be done before registry data can be incorporated into clinical trials.~PCI: Researchers were unable to obtain data from CATH-PCI registry. At the time of trial start-up, the registry was being restructured and moved to a different platform. Linkage to clinical trial data was not possible.
Secondary
Hemoglobin Levels
For HCR patients, lab values are pre- and post-CABG. For PCI patients, lab values are pre- and post- the last PCI.
Time frame: Up to 90 days post-randomization
Population: The overall analysis population represents the number of patients who contributed to at least one of the pre/post measurements. Patients randomized to the HCR arm and received PCI only OR patients randomized to the PCI arm and received CABG are not included. Most patients switched interventions due to their preference. Patients who did not receive any procedures are also excluded. Patients received no interventions due to physician decision or early termination (withdrawal or lost to follow-up).
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Hybrid Coronary Revascularization Group | Hemoglobin Levels | Pre-Procedure | 13.95 g/dL |
| Hybrid Coronary Revascularization Group | Hemoglobin Levels | Post-Procedure | 10.95 g/dL |
| Percutaneous Coronary Intervention | Hemoglobin Levels | Pre-Procedure | 13.40 g/dL |
| Percutaneous Coronary Intervention | Hemoglobin Levels | Post-Procedure | 12.90 g/dL |
Secondary
Length of Stay
Length of stay for all study procedures combined, beginning at date of procedure
Time frame: Up to 90 days post-randomization
Population: Patients with at least one post-randomization procedure are included. Additional patients are missing data on length of stay.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Hybrid Coronary Revascularization Group | Length of Stay | 7.00 days |
| Percutaneous Coronary Intervention | Length of Stay | 2.00 days |
Secondary
Number of Participants Requiring Medications
For HCR patients, medications are prior/during/after CABG. For PCI patients, medications are prior/during/after the last PCI. Number of participants requiring medications at any time 24 Hours Prior to, During, and Within 24 Hours of the Procedure. Procedures can occur up to 90 days after randomization.
Time frame: 24 Hours Prior to, During, and Within 24 Hours of the Procedure
Population: The overall analysis population represents the number of patients who contributed to at least one of the pre/post measurements. Patients randomized to the HCR arm and received PCI only OR patients randomized to the PCI arm and received CABG are not included. Most patients switched interventions due to their preference. Patients who did not receive any procedures are also excluded. Patients received no interventions due to physician decision or early termination (withdrawal or lost to follow-up).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Hybrid Coronary Revascularization Group | Number of Participants Requiring Medications | Antiplatelets | 74 Participants |
| Hybrid Coronary Revascularization Group | Number of Participants Requiring Medications | Anticoagulants | 53 Participants |
| Hybrid Coronary Revascularization Group | Number of Participants Requiring Medications | Beta Blockers | 73 Participants |
| Hybrid Coronary Revascularization Group | Number of Participants Requiring Medications | ACE Inhibitors or ARBs | 22 Participants |
| Hybrid Coronary Revascularization Group | Number of Participants Requiring Medications | Diuretics | 25 Participants |
| Hybrid Coronary Revascularization Group | Number of Participants Requiring Medications | Statins | 71 Participants |
| Percutaneous Coronary Intervention | Number of Participants Requiring Medications | Diuretics | 18 Participants |
| Percutaneous Coronary Intervention | Number of Participants Requiring Medications | Antiplatelets | 101 Participants |
| Percutaneous Coronary Intervention | Number of Participants Requiring Medications | ACE Inhibitors or ARBs | 37 Participants |
| Percutaneous Coronary Intervention | Number of Participants Requiring Medications | Anticoagulants | 66 Participants |
| Percutaneous Coronary Intervention | Number of Participants Requiring Medications | Statins | 79 Participants |
| Percutaneous Coronary Intervention | Number of Participants Requiring Medications | Beta Blockers | 65 Participants |
Secondary
Number of Participants Requiring Transfusion
Number of participants requiring transfusion during procedure and after procedure
Time frame: Up to 90 days post-randomization
Population: The overall analysis population represents the number of patients who contributed to at least one of the intra/post measurements. Patients with at least one post-randomization procedure are included. Additional patients are missing data on transfusions.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Hybrid Coronary Revascularization Group | Number of Participants Requiring Transfusion | Transfusion Intra-Procedure | 3 Participants |
| Hybrid Coronary Revascularization Group | Number of Participants Requiring Transfusion | Transfusion Post-Procedure | 6 Participants |
| Percutaneous Coronary Intervention | Number of Participants Requiring Transfusion | Transfusion Intra-Procedure | 1 Participants |
| Percutaneous Coronary Intervention | Number of Participants Requiring Transfusion | Transfusion Post-Procedure | 1 Participants |
Secondary
Troponin Levels
For HCR patients, lab values are pre- and post-CABG. For PCI patients, lab values are pre- and post- the last PCI.
Time frame: Up to 90 days post-randomization
Population: The overall analysis population represents the number of patients who contributed to at least one of the pre/post measurements. Patients randomized to the HCR arm and received PCI only OR patients randomized to the PCI arm and received CABG are not included. Most patients switched interventions due to their preference. Patients who did not receive any procedures are also excluded. Patients received no interventions due to physician decision or early termination (withdrawal or lost to follow-up).
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Hybrid Coronary Revascularization Group | Troponin Levels | Pre-Procedure Troponin I | 0.03 ng/mL |
| Hybrid Coronary Revascularization Group | Troponin Levels | Post-Procedure Troponin I | 0.30 ng/mL |
| Hybrid Coronary Revascularization Group | Troponin Levels | Pre-Procedure Troponin T | 0.03 ng/mL |
| Hybrid Coronary Revascularization Group | Troponin Levels | Post-Procedure Troponin T | 0.05 ng/mL |
| Percutaneous Coronary Intervention | Troponin Levels | Post-Procedure Troponin T | 0.01 ng/mL |
| Percutaneous Coronary Intervention | Troponin Levels | Pre-Procedure Troponin I | 0.03 ng/mL |
| Percutaneous Coronary Intervention | Troponin Levels | Pre-Procedure Troponin T | 0.01 ng/mL |
| Percutaneous Coronary Intervention | Troponin Levels | Post-Procedure Troponin I | 0.17 ng/mL |