Angina with Extremely Serious Operative Mortality Evaluation - AWESOME

Description:

Percutaneous Coronary Intervention vs. Coronary Artery Bypass Graft Surgery for Patients With Medically Refractory Myocardial Ischemia and Risk Factors for Adverse Outcomes With Bypass: A Multicenter, Randomized Trial.

Hypothesis:

Randomized trials comparing percutaneous coronary interventions (PCI) with coronary artery bypass graft surgery (CABG) have traditionally excluded high-risk patients. The objective of this study was to compare PCI with CABG in high-risk patients with medically refractory myocardial ischemia.

Study Design

Study Design:

Patients Screened: 22662
Patients Enrolled: 554

Patient Populations:

1) evidence of myocardial ischemia; 2) medically refractory ischemia; 3) presence of one or more of 5 high-risk clinical characteristics for CABG including prior open heart surgery, age >70 years, left ventricular ejection fraction <35% and myocardial infarction within 7 days or intra-aortic balloon pump requirement.

Primary Endpoints:

Survival.

Secondary Endpoints:

Unstable agina, repeat hospitalization, repeat catheterization, and repeat revascularization with CABG or PCI.

Drug/Procedures Used:

Between February 1995 and March 2000, 22,662 patients were screened in 16 Veteran Affairs Medical Centers. Eligibility criteria for enrollment in the trial were: 1) evidence of myocardial ischemia; 2) medically refractory ischemia; 3) presence of one or more of 5 high-risk clinical characteristics for CABG including prior open heart surgery, age >70 years, left ventricular ejection fraction <35% and myocardial infarction within 7 days or intra-aortic balloon pump requirement. 2431 patients met the eligibility criteria, and of these, 554 patients were randomized (232 patients to CABG and 222 patients to PCI). The primary end point was survival. Secondary end points included unstable angina, repeat hospitalization, repeat catheterization and repeat revascularization with CABG or PCI.

Principal Findings:

Over the 5-year study period progressive changes in CABG and PCI practices were observed. The use of Left Internal Mammary Artery increased from 57% in 1995 to 78% in 2000 (average 70%). The use of coronary stents increased from 26% in 1995 to 88% in 2000 (average 54%), while the use of IIb/IIIa receptor blockers increased from 1% to 52% (average 11%). The in-hospital and 30-day survival rates were 96% and 95%, respectively, for CABG and 99% and 97% for PCI. There was no difference in survival at 6-month follow-up (90% for CABG and 94% for PCI) or at 3-year follow-up(79% for CABG and 80% for PCI, p

Interpretation:

This study confirms the results of subset analysis from other randomized clinical trials. Its limitations are related to the rapid changes in PCI and CABG practice that have occurred during the study period and that render these results less applicable to current practice. In addition, follow-up data were up to 3 years, while late graft failure tends to occur beyond 3 years. Finally, although the stroke rates were the same, we do not have data on cognitive function in the two groups. Nonetheless, this study is still the most contemporary and the only randomized trial of PCI vs. CABG in high-risk patients. It is hoped that long-term follow-up will continue and that additional analysis will be made available.

References:

1. Morrison DA, Sethi G, Sacks J, et al. for the Investigators of the Department of Veterans Administration Affairs Cooperative Study #385, the Angina with Extremely Serious Operative Mortality Evaluation (AWESOME). J Am Coll Cardiol 2001;38:143-9.

Clinical Topics: Anticoagulation Management, Cardiac Surgery, Invasive Cardiovascular Angiography and Intervention, Aortic Surgery

Keywords: Myocardial Infarction, Stroke, Cognition, Follow-Up Studies, Risk Factors, Angioplasty, Balloon, Coronary, Percutaneous Coronary Intervention, Stents, Survival Rate, Catheterization, Stroke Volume, Nadroparin, Cardiac Surgical Procedures, Coronary Artery Bypass


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