A multicenter, randomized trial of percutaneous coronary intervention versus bypass surgery in high-risk unstable angina patients

This multicenter, prospective randomized trial was designed to test the hyp otheses that percutaneous coronary intervention (PCI) is a safe and effecti ve alternative to coronary artery bypass grafting (CABG) for patients with refractory ischemia and high risk of adverse outcomes. As a comparison of r evascularization strategies, the trial specifically allows surgeons and int erventionists to use new techniques as they become clinically available. Af ter 42 months of this 72-month trial, 17,624 patients have been screened an d 2022 met eligibility requirements: 341 have been randomized to either CAB G or PCI, and the remaining 1681 are being prospectively followed in a regi stry. The 3-year overall survival of patients in the registry and randomize d trial is comparable. To enhance accrual into the randomized trial, site v isits were conducted, a few low-accruing hospitals were put on probation an d/or replaced, eligibility criteria were reviewed at annual meetings of inv estigators, and the accrual period was extended by 1 year. These data demon strate that a prospective randomized trial and registry of coronary revascu larization for medically refractory high-risk patients is feasible. (C) Els evier Science inc. 1999.