Randomized Comparison of Eptifibatide Versus Abciximab in Primary Percutaneous Coronary Intervention in Patients With Acute ST-Segment Elevation Myocardial Infarction Results of the EVA-AMI Trial

被引:60
作者
Zeymer, Uwe [1 ,2 ]
Margenet, Alain [3 ]
Haude, Michael [4 ]
Bode, Christoph [5 ]
Lablanche, Jean-Marc [6 ]
Heuer, Hubertus [7 ]
Schroeder, Rolf [8 ]
Kropff, Stefan [9 ]
Bourkaib, Ryad [9 ]
Banik, Norbert [9 ]
Zahn, Ralf [1 ]
Teiger, Emmanuel [3 ]
机构
[1] Herzzentrum Ludwigshafen, D-67063 Ludwigshafen, Germany
[2] Inst Herzinfarktforsch Ludwigshafen, Ludwigshafen, Germany
[3] CHU Henri Mondor, F-94010 Creteil, France
[4] Lukas Krankenhaus Neuss, Neuss, Germany
[5] Univ Freiburg Klinikum, Freiburg, Germany
[6] CHRU Lille, Lille, France
[7] St Johannes Hosp, Dortmund, Germany
[8] Multizentr Klin Studien, Berlin, Germany
[9] GlaxoSmithKline Europe, London, England
关键词
PRIMARY ANGIOPLASTY; TIROFIBAN; THERAPY; REPERFUSION; INHIBITION; INTEGRILIN; INITIATION; RESOLUTION; STENTS; TIME;
D O I
10.1016/j.jacc.2009.08.093
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
Objectives The aim of this study was to compare eptifibatide and abciximab as adjuncts to primary percutaneous coronary intervention (PCI). Background The glycoprotein ( GP) IIb/IIIa receptor inhibitor abciximab as adjunct to primary PCI in patients with ST-segment elevation myocardial infarctions has been shown to reduce ischemic complications and improve clinical outcomes. So far, no trial has been performed to compare the efficacy of another GP IIb/IIIa receptor inhibitor, eptifibatide, and abciximab in primary PCI. Methods A total of 427 patients with ST-segment elevation myocardial infarctions <12 h and planned primary PCI were randomized to double-bolus eptifibatide (n = 226) followed by a 24-h infusion or single-bolus abciximab (n = 201) followed by a 12-h infusion. In this noninferiority trial, the primary end point was the incidence of complete (>= 70%) ST-segment resolution (STR) 60 min after PCI, a measure of myocardial reperfusion. The assumption was a 60% complete STR rate in the abciximab group. The noninferiority margin was set to 15%. Results The incidence of complete STR at 60 min after PCI in the intention-to-treat analysis was 62.6% after eptifibatide and 56.3% after abciximab ( adjusted difference: 7.1%; 95% confidence interval: 2.7% to 17.0%). All-cause mortality 6.2% versus 4.5% (p = 0.50); reinfarction 0.4% versus 3.5% (p = 0.03); target vessel revascularization 4.4% versus 6.5% (p = 0.40); the combined end point of death, nonfatal reinfarction, and target vessel revascularization 10.6% versus 10.9% (p = 0.90); stroke 0.5% versus 0.5% (p = 1.00) after 6 months; and Thrombolysis In Myocardial Infarction major bleeding complications 4.0% versus 2.0% (p = 0.20) after 30 days were observed after eptifibatide and abciximab, respectively. Conclusions Eptifibatide as an adjunct to primary PCI is equally as effective as abciximab with respect to STR. ( Efficacy of Eptifibatide Compared to Abciximab in Primary Percutaneous Coronary Intervention [ PCI] for Acute ST Elevation Myocardial Infarction [STEMI]; NCT00426751) ( J Am Coll Cardiol 2010; 56: 463-9) (C) 2010 by the American College of Cardiology Foundation
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收藏
页码:463 / 469
页数:7
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