Ischemic Heart Disease
Conditions
Brief summary
Ischemic heart disease is one of the most frequent diagnoses in the VA system. Moreover, 5,819 coronary artery bypass graft (CABG-only) procedures were performed in the VA in Fiscal Year (FY) 1999. Throughout VA and non-VA cardiac surgery programs nationwide, myocardial revascularization is now being performed using two surgical techniques. One technique is performed with cardiopulmonary bypass (CPB) usually with cardioplegic arrest (on-pump) and the other without CPB on a beating heart (off-pump). The overall purpose of this proposed randomized, controlled, clinical trial is to rigorously evaluate the impact of using an on-pump versus off-pump surgical technique for coronary artery bypass graft (CABG-only) procedures (performed with a traditional median sternotomy incision) upon patient clinical outcomes and resource utilization.
Detailed description
Primary Hypotheses: The study has two primary hypotheses to evaluate the impact of using an off-pump versus an on-pump surgical technique for CABG procedures. One is a short term objective to assess the immediate impact of the two surgical techniques while the second assesses the long-term impact of the two techniques: 1) Short-Term Null Hypothesis: For patients having CABG-only procedures performed, there will be no difference in the short-term composite clinical outcome (30 day death or major morbidity) between patients randomized to the on-pump and off-pump procedures, 2) Long-Term Null Hypothesis: For patients undergoing CABG-only procedures, there will be no difference in long-term clinical outcome as measured by one year mortality and/or acute myocardial infarction prior to one year and/or a subsequent revascularization procedure within one year between patients randomized to the on-pump and off-pump procedures. Secondary Hypotheses: Major secondary objectives are to determine if there are differences in patients undergoing CABG-only procedures using the on-pump and off-pump techniques for 1) long-term completeness of revascularization, 2) one year graft patency and stenosis rates as determined by angiography at one year, and 3) short-term completeness of revascularization. Other secondary objectives are to evaluate the two surgical techniques on 1) changes in neuropsychological function, 2) traditional clinical outcomes, 3) general and disease specific quality of life, and 4) use of system resources. Intervention: Patients requiring an elective or urgent CABG-only (no other procedures to be done) surgical procedure will be randomized to either the off-pump procedure or to the on-pump procedure. Primary Outcomes: The short-term primary outcome measure is a composite measure of death, repeat cardiac surgery, new technical support, cardiac arrest, coma, prolonged stroke and/or renal failure requiring dialyses occurring within 30 days of surgery or prior to discharge, whichever is latest. The long-term primary outcome measure is a composite of death, acute myocardial infarction, and/or subsequent revascularization procedure prior to one year post-surgery. Study Abstract: Ischemic heart disease is one of the most frequent diagnoses in the VA system. Moreover, 5,819 coronary artery bypass graft (CABG-only) procedures were performed in the VA in FY 1999. Throughout VA and non-VA cardiac surgery programs nationwide, myocardial revascularization is now being performed using two surgical techniques. One technique is performed with cardiopulmonary bypass (CPB) usually with cardioplegic arrest (on-pump) and the other without CPB on a beating heart (off-pump). The overall purpose of this proposed randomized, controlled, clinical trial is to rigorously evaluate the impact of using an on-pump versus off-pump surgical technique for coronary artery bypass graft (CABG-only) procedures (performed with a traditional median sternotomy incision) upon patient clinical outcomes and resource utilization.
Interventions
PROCEDURECoronary artery bypass - on-pump
CABG procedure performed on heart lung machine
PROCEDURECoronary artery bypass - off-pump
CABG procedure performed without the use of the heart lung machine
Sponsors
US Department of Veterans Affairs
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Elective or Urgent CABG * CABG only procedure to be performed
Exclusion criteria
* Patient's surgeon is not a participant that meets study off-pup criteria * Valve or Valve/CABG procedure * Emergent, hemodynamically unstable, or in cardiogenic shock preoperatively * Moderate, moderate, to severe, or severe valvular disease * Enrolled in another therapeutic or interventional study * Majority of diffusely diseased distal vessels * Clinical Care Team has reservations * History of on-compliance * Patient preference for treatment arm * Inability to provide informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Short-term End Point | 30 day | Short-term end point was a composite of death or major complications (reoperation, new mechanical support, cardiac arrest, coma, stroke, or renal failure requiring dialysis) occuring within 30 days after surgery or before discharge, whichever was later. |
| Long-term Composite | one-year | Long-term composite endpoint was death from any cause within 1 year, nonfatal myocardial infarction between 30 days and 1 year, or repeat revascularization between 30 days and 1 year. |
Countries
United States
Participant flow
Recruitment details
From February 2002 to May 2007, a total of 9663 patients who were scheduled for urgent or elective Coronary Artery Bypass Graft (CABG) were screened for enrollment. Of these, 7460 patients were excluded, mostly because of diffusely diseased or small coronary arteries. Overall,1099 patients were randomized to on-pump and 1104 randomized to off-pump
Participants by arm
| Arm | Count |
|---|---|
| On Pump Coronary artery bypass performed on a non beating heart using a heart-lung machine | 1,099 |
| Off Pump Coronary artery bypass performed on a beating heart with no heart-lung machine | 1,104 |
| Total | 2,203 |
Baseline characteristics
| Characteristic | Off Pump | On Pump | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 433 Participants | 400 Participants | 833 Participants |
| Age, Categorical Between 18 and 65 years | 671 Participants | 699 Participants | 1370 Participants |
| Age, Continuous | 63.0 years STANDARD_DEVIATION 8.5 | 62.5 years STANDARD_DEVIATION 8.5 | 62.74 years STANDARD_DEVIATION 8.49 |
| Region of Enrollment United States | 1104 participants | 1099 participants | 2203 participants |
| Sex: Female, Male Female | 7 Participants | 6 Participants | 13 Participants |
| Sex: Female, Male Male | 1097 Participants | 1093 Participants | 2190 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 1,099 | 0 / 1,104 |
| serious Total, serious adverse events | 201 / 1,099 | 220 / 1,104 |
Outcome results
Primary
Long-term Composite
Long-term composite endpoint was death from any cause within 1 year, nonfatal myocardial infarction between 30 days and 1 year, or repeat revascularization between 30 days and 1 year.
Time frame: one-year
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| On Pump | Long-term Composite | 78 Participants |
| Off Pump | Long-term Composite | 105 Participants |
Primary
Short-term End Point
Short-term end point was a composite of death or major complications (reoperation, new mechanical support, cardiac arrest, coma, stroke, or renal failure requiring dialysis) occuring within 30 days after surgery or before discharge, whichever was later.
Time frame: 30 day
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| On Pump | Short-term End Point | 61 participants |
| Off Pump | Short-term End Point | 77 participants |