Clinical Research
Clinical Trial
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

https://doi.org/10.1016/j.jacc.2006.11.052Get rights and content
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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 ≥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 (≥5 segments 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.

Abbreviations and Acronyms

ACC
American College of Cardiology
AHA
American Heart Association
CABG
coronary artery bypass graft
CI
confidence interval
LVEF
left ventricular ejection fraction
OR
odds ratio
PCI
percutaneous coronary intervention

Cited by (0)

Members of the DECREASE Study Group are listed in the Appendix. Kim Eagle, MD, acted as the Guest Editor for this article.