Percutaneous coronary coronary bypass graft intervention versus surgery for patients with medically refractory myocardial ischemia and risk factors for adverse outcomes with bypass - The VA AWESOME Multicenter Registry: Comparison with the randomized clinical trial

OBJECTIVES This study was designed to compare the three-year survival after percutaneous coronary intervention (PCI) or coronary artery, by-pass graft surgery (CABG) in physician-directed and patient-choice registries with the Angina With Extremely Serious Operative Mortality Evaluation (AWESOME) randomized trial results. BACKGROUND The AWESOME multicenter randomized trial and registry compared the long-term survival after PCI and CABG for the treatment of patients with medically refractory myocardial ischemia and at least one additional risk factor for adverse outcome with CABG. The randomized trial demonstrated comparable three-year survival. METHODS Over a five-year period (1995 to 2000), 2,431 patients with medically, refractory myocardial ischemia and at least one of five risk factors (prior heart surgery, myocardial infarction within seven days, left ventricular ejection fraction <0.35, age >70 years, intra-aortic balloon required to stabilize) were identified. By physician consensus, 1,650 patients formed a physician-directed registry assigned to CABG (692), PCI (651) or further medical therapy (307), and 781 were angiographically eligible for random allocation; 454 of these patients constitute the randomized trial, and the remaining 327 constitute a patient choice registry. Survival for CABG and PCI was compared using Kaplan-Meier curves and log-rank tests. RESULTS The CABG and PCI 36-month survival rates for randomized patients were 79% and 80%, respectively. The CABG and PCI 36-month survival rates were both 76% for the physician-directed subgroup; comparable survival rates for the patient-choice subgroup were 80% and 89%, respectively. None of the global log-rank tests for survival demonstrated significant differences. CONCLUSIONS Both registries support the randomized trial conclusion: PCI is an alternative to CABG for some medically refractory high-risk patients. (C) 2002 by the American College of Cardiology.