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The Journal of Cardiovascular Surgery 2016 February;57(1):100-10

Copyright © 2016 EDIZIONI MINERVA MEDICA

language: English

Eptifibatide infusion versus placebo in high risk patients with non-ST segment elevation acute coronary syndromes managed with urgent coronary artery bypass graft surgery. A prospective multicenter randomized placebo-controlled clinical trial

Mirosław WILCZYNSKI 1, Maciej T. WYBRANIEC 2, Krzysztof MILEWSKI 3, Marek SANAK 4, Krystian WITA 2, Łukasz BULDAK 5, Marek KONDYS 3, Paweł BUSZMAN 3, Andrzej BOCHENEK 1, 3

1 Department of Cardiac Surgery, Medical University of Silesia, Katowice, Poland; 2 First Department of Cardiology, School of Medicine in Katowice, Medical University of Silesia, Katowice, Poland; 3 Center for Cardiovascular Research and Development, American Heart of Poland, Katowice, Poland; 4 Division of Molecular Biology and Clinical Genetics, Jagiellonian University Medical College, Krakow, Poland; 5 Department of Internal Medicine and Clinical Pharmacology, Medical University of Silesia, Katowice, Poland


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BACKGROUND: This randomized prospective clinical trial aimed to evaluate safety and efficacy of preoperative use of eptifibatide in high risk patients with non-ST-segment elevation acute coronary syndrome (NSTE-ACS), requiring urgent coronary artery bypass graft surgery (CABG).
METHODS: A total of 140 patients with NSTE-ACS eligible for urgent surgical revascularization received either eptifibatide (bolus plus infusion) 12-48 hours prior to surgery (N.=72 patients) or placebo (normal saline; N.=68 patients) followed by routinely administered enoxaparin and aspirin. Patients were regarded as unsuitable for percutaneous coronary intervention by the heart team. CABG was performed 4 hours after discontinuation of eptifibatide or placebo infusion. The primary end point was major adverse cardiac and cerebrovascular events (MACCE) defined as death, nonfatal myocardial infarction (MI), stroke and the need for rehospitalization due to recurrent ischemia at 12-month follow-up. Secondary endpoints included MACCE rate at 1 month, bleeding complications, platelet inhibition efficacy and correlation of platelet activity with MACCE rate.
RESULTS: Cumulative one year MACCE rate was 35% vs. 14% in the control and treated group respectively (P=0.012). Mortality rate at 30 days follow-up was 10% vs. 3% (P=0.021) and was not changed at 12-month follow-up. There was a significant difference between both groups regarding perioperative MI (22% vs. 8%, P=0.03). The rates of stroke, blood loss and blood transfusion were similar in both groups.
CONCLUSION: Preoperative use of eptifibatide vs. placebo is linked to significantly reduced 12-month MACCE rate in patients with NSTE-ACS requiring urgent CABG, while it simultaneously seems not to confer a greater risk of postoperative bleeding.

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miroslaw.wilczynski@cardiosurg.pl