Outcomes Following Myocardial Revascularization: On and Off Cardiopulmonary Bypass

Phase 3

Completed

Conditions: Ischemic Heart Disease

Interventions: Procedure: Coronary artery bypass - off-pump
Procedure: Coronary artery bypass - on-pump

Registration Number: NCT00032630

Lead Sponsor: US Department of Veterans Affairs

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 2203

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 2	Coronary artery bypass - off-pump	Coronary artery bypass - off-pump
Arm 1	Coronary artery bypass - on-pump	Coronary artery bypass - on-pump

Primary Outcome Measures

Name	Time	Method
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.
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.

Secondary Outcome Measures

Name	Time	Method

Trial Locations

Locations (17): VA Medical Center, Asheville
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Asheville, North Carolina, United States
VA North Texas Health Care System, Dallas
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Dallas, Texas, United States
VA Medical Center, San Francisco
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San Francisco, California, United States
VA Eastern Colorado Health Care System, Denver
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Denver, Colorado, United States
James A. Haley Veterans Hospital, Tampa
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Tampa, Florida, United States
VA Medical Center, Durham
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Durham, North Carolina, United States
VA Medical Center, Cleveland
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Cleveland, Ohio, United States
VA Medical Center, Portland
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Portland, Oregon, United States
VA South Texas Health Care System, San Antonio
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San Antonio, Texas, United States
Zablocki VA Medical Center, Milwaukee
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Milwaukee, Wisconsin, United States
VA Palo Alto Health Care System
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Palo Alto, California, United States
VA Medical Center, DC
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Washington, District of Columbia, United States
VA Greater Los Angeles HCS, Sepulveda
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Sepulveda, California, United States
VA Medical Center, Miami
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Miami, Florida, United States
North Florida/South Georgia Veterans Health System
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Gainesville, Florida, United States
New Mexico VA Health Care System, Albuquerque
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Albuquerque, New Mexico, United States
VA Pittsburgh Health Care System
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Pittsburgh, Pennsylvania, United States