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.
Original language | English (US) |
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Pages (from-to) | 601-619 |
Number of pages | 19 |
Journal | Controlled Clinical Trials |
Volume | 20 |
Issue number | 6 |
DOIs | |
State | Published - Dec 1999 |
Externally published | Yes |
Keywords
- Angina
- Angioplasty
- Bypass
- Coronary disease
- Revascularization
ASJC Scopus subject areas
- Pharmacology