title: 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.
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.
authors.affiliation: Cardiology, Tucson VAMC, AZ 85723, USA.
authors.forename: D A
authors.initials: DA
authors.lastname: Morrison
authors.forename: G
authors.initials: G
authors.lastname: Sethi
authors.forename: J
authors.initials: J
authors.lastname: Sacks
authors.forename: F
authors.initials: F
authors.lastname: Grover
authors.forename: S
authors.initials: S
authors.lastname: Sedlis
authors.forename: R
authors.initials: R
authors.lastname: Esposito
authors.forename: K B
authors.initials: KB
authors.lastname: Ramanathan
authors.forename: D
authors.initials: D
authors.lastname: Weiman
authors.forename: M
authors.initials: M
authors.lastname: Krucoff
authors.forename: F
authors.initials: F
authors.lastname: Duhaylongsod
authors.forename: T
authors.initials: T
authors.lastname: Raya
authors.forename: S
authors.initials: S
authors.lastname: Pett
authors.forename: S
authors.initials: S
authors.lastname: Vernon
authors.forename: V
authors.initials: V
authors.lastname: Birjiniuk
authors.forename: D
authors.initials: D
authors.lastname: Booth
authors.forename: C
authors.initials: C
authors.lastname: Robinson
authors.forename: J D
authors.initials: JD
authors.lastname: Talley
authors.forename: T
authors.initials: T
authors.lastname: Antckli
authors.forename: E
authors.initials: E
authors.lastname: Murphy
authors.forename: H
authors.initials: H
authors.lastname: Floten
authors.forename: V
authors.initials: V
authors.lastname: Curcovic
authors.forename: J C
authors.initials: JC
authors.lastname: Lucke
authors.forename: D
authors.initials: D
authors.lastname: Lewis
authors.forename: C
authors.initials: C
authors.lastname: Barbiere
authors.forename: W
authors.initials: W
authors.lastname: Henderson
mesh_terms: D000367:Age Factors; D000368:Aged; D000789:Angina, Unstable / Q000150:complications; D002303:Cardiac Output, Low / Q000150:complications; D001026:Coronary Artery Bypass; D005240:Feasibility Studies; D005500:Follow-Up Studies; D006801:Humans; D007423:Intra-Aortic Balloon Pumping; D017202:Myocardial Ischemia / Q000601:surgery / Q000628:therapy*; D009204:Myocardial Revascularization; D018579:Patient Selection; D011446:Prospective Studies; D012008:Recurrence; D012042:Registries; D012086:Reoperation; D012307:Risk Factors; D015996:Survival Rate; D016896:Treatment Outcome