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CLINICAL RESEARCH: CLINICAL TRIALS

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

Don Poldermans, MD^_*,_*, Olaf Schouten, MD, Radosav Vidakovic, MD, Jeroen J. Bax, MD, Ian R. Thomson, MD^||, Sanne E. Hoeks, MSc, Harm H.H. Feringa, MD, Martin Dunkelgrün, MD, Peter de Jaegere, MD, Alexander Maat, MD^¶, Marc R.H.M. van Sambeek, MD, Miklos D. Kertai, MD^_*, Eric Boersma, PhD for the DECREASE Study Group

^_* Anesthesiology
Vascular Surgery
Cardiology
^¶ Cardiothoracic Surgery, Erasmus Medical Center, Rotterdam, the Netherlands
Department of Cardiology, Leiden University Medical Center, Leiden, the Netherlands
^|| Department of Anesthesiology, University of Alberta, Winnipeg, Manitoba, Canada

Manuscript received July 19, 2006; revised manuscript received October 31, 2006, accepted November 2, 2006.

^_* Reprint requests and correspondence: Dr. Don Poldermans, Room H921, Department of Anesthesiology, Erasmus Medical Center, 3015 GD Rotterdam, the Netherlands (Email: d.poldermans{at}erasmusmc.nl).

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

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