Prophylactic coronary artery revascularization for elective vascular surgery: Study design

This article describes the design of an ongoing randomized trial intended t o test whether patients who require elective vascular surgery would benefit from preoperative coronary artery revascularization prior to the vascular procedure. The primary objective is to determine whether coronary artery re vascularization reduces long-term mortality (mean 3.5 years) in patients un dergoing vascular surgery. The study design calls for 620 patients to be ra ndomized and followed for a mean of 3.5 years following vascular surgery. S econdary endpoints include measures of quality of life and cost-effectivene ss. Patients with coronary artery disease in need of an elective vascular o peration are considered candidates for the study. Anatomic exclusion criter ia include ejection fraction <20%, severe aortic stenosis (valve area <1.0 cm(2)), left main stenosis greater than or equal to 50%, nonobstructive cor onary artery disease (stenosis <70%), and coronary arteries that are not am enable to revascularization. Prior to the Vascular surgery, the trial rando mizes eligible patients to coronary artery revascularization (either bypass surgery or angioplasty) versus medical therapy. The trial stratifies the r andomization by hospital and type of vascular surgery. (intraabdominal vers us infrainguinal) because of differences in long-term prognosis in those pa tients. A 1-year feasibility trial involving five Veterans Affairs (VA) med ical centers of variable vascular surgical loads has been completed. The re sults showed that over 90% of expected patients could be randomized. As a r esult, a larger VA Cooperative Study involving 18 centers will begin recrui tment of patients. The findings should help determine the best strategy for managing patients with coronary artery disease in need of elective vascula r surgery. Control Clin Trials 1999;20:297-308 (C) Elsevier Science Inc. 19 99.