CSP #411 - The Coronary Artery Revascularization Prophylaxis (CARP) Trial

Primary Hypothesis: Prophylactic coronary artery revascularization in high risk patients scheduled for elective vascular surgery reduces long-term risk of mortality.

Secondary Hypotheses: Prophylactic coronary artery revascularization in high risk patients scheduled for elective vascular surgery reduces long-term risk of myocardial infarction and improves both cost-effectiveness of treatment and quality of life of the patients.

Intervention: 1) Medical therapy. This is the current, conservative practice. Each local investigator will decide the best medical treatment consistent with that given to any patient scheduled for elective vascular surgery. In patients with coronary artery disease, long-term treatment would be expected to include a combination of antiplatelet agents, beta-blockers, calcium channel blockers, and nitrates. Vascular surgery should occur as soon as possible but no later than three months after randomization. 2) Coronary artery revascularization. Repair of the heart in patients with coronary artery disease may aid in the protection of these patients when they undergo vascular surgery. The surgeon is free to choose between coronary artery bypass grafting (CABG) and percutaneous transluminal coronary angioplasty (PTCA). Coronary artery revascularization should occur as soon as possible after randomization. Vascular surgery should occur between one and three months following CABG or between three to four days and three months following PTCA.

Primary Outcomes: Long-term mortality, MI, and quality of life.

Study Abstract: Cardiovascular disease accounts for one million deaths per year and is the major cause of mortality among Americans. Studies have shown that in patients scheduled for elective vascular surgery, the prevalence of coronary artery disease exceeds 50%. It is not surprising, therefore, that "perioperative cardiac morbidity" defined as the occurrence of MI, unstable angina, CHF, arrhythmias, and cardiac death, is the leading cause of perioperative complications. Although a number of sophisticated diagnostic tests have been shown to be helpful in identifying patients at high risk for perioperative cardiac complications, no study has addressed the most important question: Should prophylactic coronary revascularization be performed prior to elective vascular surgery? This study is designed to answer this question.