CLINICAL RESEARCH: CLINICAL TRIAL
A Clinical Randomized Trial to Evaluate the Safety of a Noninvasive Approach in High-Risk Patients Undergoing Major Vascular SurgeryThe 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
* Department of Anesthesiology, Erasmus Medical Center, Rotterdam, the Netherlands
Department of Vascular Surgery, Erasmus Medical Center, Rotterdam, the Netherlands
Department of Cardiology, Erasmus Medical Center, Rotterdam, the Netherlands
¶ Department of 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.
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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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