A multicenter, randomized trial of percutaneous coronary intervention versus bypass surgery in high-risk unstable angina patients. The AWESOME (Veterans Affairs Cooperative Study #385, angina with extremely serious operative mortality evaluation) investigators from the Cooperative Studies Program of the Department of Veterans Affairs.
(Clinical Trial;Journal Article;Multicenter Study)
This multicenter, prospective randomized trial was designed to test the hypotheses that percutaneous coronary intervention (PCI) is a safe and effective alternative to coronary artery bypass grafting (CABG) for patients with refractory ischemia and high risk of adverse outcomes. As a comparison of revascularization strategies, the trial specifically allows surgeons and interventionists to use new techniques as they become clinically available. After 42 months of this 72-month trial, 17,624 patients have been screened and 2022 met eligibility requirements: 341 have been randomized to either CABG or PCI, and the remaining 1681 are being prospectively followed in a registry. The 3-year overall survival of patients in the registry and randomized trial is comparable. To enhance accrual into the randomized trial, site visits were conducted, a few low-accruing hospitals were put on probation and/or replaced, eligibility criteria were reviewed at annual meetings of investigators, and the accrual period was extended by 1 year. These data demonstrate that a prospective randomized trial and registry of coronary revascularization for medically refractory high-risk patients is feasible.
Morrison, DA; Sethi, G; Sacks, J; Grover, F; Sedlis, S; Esposito, R; Ramanathan, KB; Weiman, D; Krucoff, M; Duhaylongsod, F; Raya, T; Pett, S; Vernon, S; Birjiniuk, V; Booth, D; Robinson, C; Talley, JD; Antckli, T; Murphy, E; Floten, H; Curcovic, V; Lucke, JC; Lewis, D; Barbiere, C; Henderson, W
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