A Clinical Randomized Trial to Evaluate the Safety of a Noninvasive Approach in High-Risk Patients Undergoing Major Vascular Surgery: The DECREASE-V Pilot Study

J Am Coll Cardiol. 2007 May 1;49(17):1763-9. doi: 10.1016/j.jacc.2006.11.052. Epub 2007 Apr 16.

Abstract

Objectives: The purpose of this research was to perform a feasibility study of prophylactic coronary revascularization in patients with preoperative extensive stress-induced ischemia.

Background: Prophylactic coronary revascularization in vascular surgery patients with coronary artery disease does not improve postoperative outcome. If a beneficial effect is to be expected, then at least those with extensive coronary artery disease should benefit from this strategy.

Methods: One thousand eight hundred eighty patients were screened, and those with > or =3 risk factors underwent cardiac testing using dobutamine echocardiography (17-segment model) or stress nuclear imaging (6-wall model). Those with extensive stress-induced ischemia (> or =5 segments or > or =3 walls) were randomly assigned for additional revascularization. All received beta-blockers aiming at a heart rate of 60 to 65 beats/min, and antiplatelet therapy was continued during surgery. The end points were the composite of all-cause death or myocardial infarction at 30 days and during 1-year follow-up.

Results: Of 430 high-risk patients, 101 (23%) showed extensive ischemia and were randomly assigned to revascularization (n = 49) or no revascularization. Coronary angiography showed 2-vessel disease in 12 (24%), 3-vessel disease in 33 (67%), and left main in 4 (8%). Two patients died after revascularization, but before operation, because of a ruptured aneurysm. Revascularization did not improve 30-day outcome; the incidence of the composite end point was 43% versus 33% (odds ratio 1.4, 95% confidence interval 0.7 to 2.8; p = 0.30). Also, no benefit during 1-year follow-up was observed after coronary revascularization (49% vs. 44%, odds ratio 1.2, 95% confidence interval 0.7 to 2.3; p = 0.48).

Conclusions: In this randomized pilot study, designed to obtain efficacy and safety estimates, preoperative coronary revascularization in high-risk patients was not associated with an improved outcome.

Publication types

  • Multicenter Study
  • Randomized Controlled Trial

MeSH terms

  • Aged
  • Angioplasty, Balloon, Coronary*
  • Coronary Artery Bypass*
  • Exercise Test
  • Feasibility Studies
  • Female
  • Follow-Up Studies
  • Humans
  • Male
  • Middle Aged
  • Myocardial Ischemia / etiology
  • Myocardial Ischemia / prevention & control*
  • Myocardial Ischemia / surgery
  • Pilot Projects
  • Risk Factors
  • Stents*
  • Treatment Outcome
  • Vascular Surgical Procedures*