Prophylactic coronary artery revascularization for elective vascular surgery: Study design

This article describes the design of an ongoing randomized trial intended to 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 revascularization reduces long-term mortality (mean 3.5 years) in patients undergoing vascular surgery. The study design calls for 620 patients to be randomized and followed for a mean of 3.5 years following vascular surgery. Secondary endpoints include measures of quality of life and cost-effectiveness. Patients with coronary artery disease in need of an elective vascular operation are considered candidates for the study. Anatomic exclusion criteria include ejection fraction <20%, severe aortic stenosis (valve area <1.0 cm(2)), left main stenosis greater than or equal to 50%, nonobstructive coronary artery disease (stenosis <70%), and coronary arteries that are not amenable to revascularization. Prior to the Vascular surgery, the trial randomizes eligible patients to coronary artery revascularization (either bypass surgery or angioplasty) versus medical therapy. The trial stratifies the randomization by hospital and type of vascular surgery. (intraabdominal versus infrainguinal) because of differences in long-term prognosis in those patients. A 1-year feasibility trial involving five Veterans Affairs (VA) medical centers of variable vascular surgical loads has been completed. The results showed that over 90% of expected patients could be randomized. As a result, a larger VA Cooperative Study involving 18 centers will begin recruitment of patients. The findings should help determine the best strategy for managing patients with coronary artery disease in need of elective vascular surgery. Control Clin Trials 1999;20:297-308 (C) Elsevier Science Inc. 1999.