A Phase 3 interventional study of Coronary artery bypass - on-pump and Coronary artery bypass - off-pump in Ischemic Heart Disease, sponsored by US Department of Veterans Affairs. Completed at 17 sites in United States. Per ClinicalTrials.gov, last updated 2014-05-05.
Sponsored by US Department of Veterans Affairs · Phase 3, Interventional, and Treatment
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.
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.
3,639 studies on the registry are indexed under Heart Diseases; 461 are open to participants now.
This study's enrollment of 2,203 is above the median of 100 across 1,778 interventional studies indexed under Heart Diseases.
Browse Heart Diseases studies →US Department of Veterans Affairs is the lead sponsor of 658 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Coronary artery bypass - on-pump
Procedure: Coronary artery bypass - on-pump
Coronary artery bypass - off-pump
Procedure: Coronary artery bypass - off-pump
CABG procedure performed on heart lung machine
CABG procedure performed without the use of the heart lung machine
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
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
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
| Milestone | On Pump | Off Pump |
|---|---|---|
| Started | 1099 | 1104 |
| Completed | 1050 | 1061 |
| Not completed | 49 | 43 |
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.
| participants | On Pump | Off Pump |
|---|---|---|
| Short-term End Point | 61 (0.1 to 4.9) | 77 (0.1 to 4.9) |
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.
| Participants | On Pump | Off Pump |
|---|---|---|
| Long-term Composite | 78 | 105 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| On Pump | — | 201/1,099 (18.3%) | 0/1,099 (0%) |
| Off Pump | — | 220/1,104 (19.9%) | 0/1,104 (0%) |
| Event | On Pump | Off Pump |
|---|---|---|
| Chest PainCardiac disorders | 64/1099 | 69/1104 |
| Myocardial InfarctionCardiac disorders | 18/1099 | 36/1104 |
| Congestive Heart FailureCardiac disorders | 33/1099 | 30/1104 |
| Pleural EffusionRespiratory, thoracic and mediastinal disorders | 32/1099 | 30/1104 |
| Atrial FibrillationCardiac disorders | 15/1099 | 22/1104 |
| Wound InfectionInfections and infestations | 20/1099 | 14/1104 |
| CVANervous system disorders | 19/1099 | 19/1104 |
| Age, Categorical(Participants) | On Pump | Off Pump | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 699 | 671 | 1370 |
| >=65 years | 400 | 433 | 833 |
| Age, Continuous(years) | On Pump | Off Pump | Total |
|---|---|---|---|
| Mean | 62.5 ± 8.5 | 63.0 ± 8.5 | 62.74 ± 8.49 |
| Sex: Female, Male(Participants) | On Pump | Off Pump | Total |
|---|---|---|---|
| Female | 6 | 7 | 13 |
| Male | 1093 | 1097 | 2190 |
| Region of Enrollment(participants) | On Pump | Off Pump | Total |
|---|---|---|---|
| United States | 1099 | 1104 | 2203 |
This study is completed, as verified in Apr 2014. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
US Department of Veterans Affairs