Coronary Artery Revascularization Prophylaxis - CARP

Description:

Coronary Artery Revascularization Prophylaxis (CARP) was a multicenter, VA-based trial of revascularization versus medical management prior to elective vascular surgery in stable patients with angiographic evidence of coronary artery disease.

Hypothesis:

Routine revascularization for patients with stable coronary artery disease prior to elective vascular surgery would be associated with improved long-term mortality compared to a strategy of medical therapy.

Study Design

Study Design:

Patients Screened: 5,859
Patients Enrolled: 510
Mean Follow Up: Median 2.7 years

Patient Populations:

Patients scheduled for elective aortic or infrainguinal vascular surgery

Exclusions:

Clinical and angiographic exclusion criteria were applied (e.g., insufficient risk of coronary artery disease to warrant diagnostic angiography, need for urgent vascular surgery, or comorbidities precluding safe revascularization such as left main coronary artery disease, severely depressed ejection fraction)

Primary Endpoints:

Long-term mortality through the study period (median follow-up of 2.7 years)

Secondary Endpoints:

Postoperative adverse events including myocardial infarction, stroke, loss of limb, and renal failure requiring hemodialysis; delays in performance of surgery; and 30-day mortality

Drug/Procedures Used:

Randomization to medical therapy alone or revascularization with either percutaneous coronary intervention or coronary artery bypass grafting (as deemed appropriate by a panel comprised of a cardiologist, cardiothoracic surgeon, and a vascular surgeon)

Concomitant Medications:

Aspirin, statins, and beta-blockers

Principal Findings:

Among the 5,859 patients screened, 510 patients were randomized in the protocol (80% of the initial screened cohort met clinical exclusion criteria while the rest were excluded following diagnostic angiography). Approximately one third of patients were scheduled for abdominal aortic aneurysm surgery and greater than 40% of patients were diabetic and had a history of prior myocardial infarction. Of the patients assigned to revascularization prior to vascular surgery, 93% received the assigned therapy prior to vascular surgery.

The incidence of the primary endpoint was no different in the two study arms in both a treatment-received analysis and when the data were analyzed by intent-to-treat (22% mortality in the revascularization arm vs. 23% in the medical arm, p=0.92 at 2.7 years, the median follow-up period). There were no significant differences between the two study groups in the endpoints of 30-day mortality (3.1% vs. 3.4%, p=0.82) or postoperative myocardial infarction (11.6% vs. 14.3%, p=0.37). There were significantly greater delays in the time to performance of vascular surgery in the revascularization arm (54 days vs. 18 days in the medical therapy arm, p<0.001).

Interpretation:

In this well-designed randomized multicenter study conducted within the VA Medical System, a strategy of routine revascularization prior to elective vascular surgery was not associated with improved outcomes compared to a strategy of aggressive medical management, and resulted in greater delays in performing the vascular surgical procedure. The study results support the current ACC/AHA guidelines for the perioperative management of patients undergoing elective noncardiac surgery, which recommend revascularization prior to surgery in high risk or unstable patients or in patients whose clinical status would likely require revascularization independent of the elective surgery being performed. The study also demonstrates that coronary revascularization can be safely performed in patients deemed candidates for revascularization prior to elective vascular surgery.

References:

McFalls EO, et al. Coronary-Artery Revascularization before Elective Major Vascular Surgery. N Engl J Med 2004;351:2795-804.

Presented by Edward O. McFalls at the American Heart Association Scientific Sessions, November 2004, New Orleans, LA.

Clinical Topics: Cardiac Surgery, Invasive Cardiovascular Angiography and Intervention, Vascular Medicine, Atherosclerotic Disease (CAD/PAD), Aortic Surgery, Interventions and Coronary Artery Disease, Interventions and Vascular Medicine

Keywords: Coronary Artery Disease, Myocardial Infarction, Coronary Artery Bypass, Aortic Aneurysm, Abdominal, Diabetes Mellitus, Peripheral Vascular Diseases, Percutaneous Coronary Intervention


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