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

Control Clin Trials. 1999 Dec;20(6):601-19. doi: 10.1016/s0197-2456(99)00033-1.

Abstract

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.

Publication types

  • Clinical Trial
  • Comparative Study
  • Multicenter Study
  • Randomized Controlled Trial

MeSH terms

  • Age Factors
  • Aged
  • Angina, Unstable / complications
  • Cardiac Output, Low / complications
  • Coronary Artery Bypass*
  • Feasibility Studies
  • Follow-Up Studies
  • Humans
  • Intra-Aortic Balloon Pumping
  • Myocardial Ischemia / surgery
  • Myocardial Ischemia / therapy*
  • Myocardial Revascularization*
  • Patient Selection
  • Prospective Studies
  • Recurrence
  • Registries
  • Reoperation
  • Risk Factors
  • Survival Rate
  • Treatment Outcome