Question: In patients with clinically stable coronary artery disease, who are scheduled for elective abdominal aortic or infrainguinal vascular surgery, does prophylactic coronary artery revascularization prior to vascular surgery reduce long-term mortality? Population: Patients met inclusion criteria if they were undergoing elective vascular surgery and a cardiologist considered them at increased risk for perioperative cardiac complications based on clinical risk factors or the presence of ischemia on nuclear stress imaging. After coronary angiography, patients were considered eligible for randomization if they had a <70% stenosis in one or more major coronary artery that was suitable for revascularization. Patients with unstable angina, stenosis of the left main coronary artery of >50%, left ventricular ejection fraction <20%, or severe aortic stenosis were excluded from the trial. Design and methods: During 1997-2003 from 18 Veterans Administration centers in the USA, 5859 patients were screened, of which 80% were initially excluded because of insufficient cardiac risk or no evidence of ischemia on nuclear imaging ( n = 2280), urgent vascular surgery ( n = 1025), severe coexisting comorbidities ( n = 731), or refusal to participate or enrolment in other studies ( n = 633). Of the remaining 1190 patients who underwent coronary angiography, 680 (57%) were excluded for the following reasons: non-occlusive or non-operable coronary artery disease 363 (53%) and 215 (32%), respectively; and exclusions (e.g. left main coronary artery disease) 15%. A randomized design was used to assign 510 patients (98% men) to a strategy of preoperative coronary artery revascularization ( n = 258), or no revascularization ( n = 252), before vascular surgery. Of the participants, 74% had more than three of the Eagle clinical criteria, or more than two of the variables of the Revised Cardiac Risk Index, or a moderate to large reversible defect on imaging (71% of the 65% participants who received nuclear stress tests). Also, 33% of participants had three-vessel coronary artery disease. The choice of coronary revascularization, either percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG), was left to the discretion of the study centers. The primary outcome was long-term all-cause mortality. Secondary outcomes were perioperative mortality or myocardial infarction, stroke, limb loss, or dialysis. The analysis followed the intention-to-treat principle. Results: Median follow-up was 2.7 years and follow-up was 100% complete. Long-term all-cause mortality did not differ between the two groups: 67 (26%) patients in the non-revascularization group and 70 (27%) patients in the revascularization group died (RRR 4%; 95% CI - 32 to 30). There was also no difference in perioperative mortality ( p = 0.87), myocardial infarction ( p = 0.37), stroke ( p = 0.59), limb loss ( p = 0.11), and dialysis ( p = 0.97). Conclusions: In patients with clinically stable coronary artery disease, who are scheduled for elective abdominal aortic or infrainguinal vascular surgery, prophylactic coronary artery revascularization using PCI or CABG prior to surgery did not reduce long-term all-cause mortality.
