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CLINICAL RESEARCH: INTERVENTIONAL CARDIOLOGY

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

Uwe Zeymer, MD^_*,,_*, Alain Margenet, MD, Michael Haude, MD, Christoph Bode, MD^||, Jean-Marc Lablanche, MD^¶, Hubertus Heuer, MD^#, Rolf Schröder, MD^_**, Stefan Kropff, MD, Ryad Bourkaib, MD, Norbert Banik, PhD, Ralf Zahn, MD^_* and Emmanuel Teiger, MD, PhD

^_* Herzzentrum Ludwigshafen, Ludwigshafen, Germany
Institut für Herzinfarktforschung Ludwigshafen, Ludwigshafen, Germany
CHU Henri Mondor, Creteil, France
Lukas-Krankenhaus Neuss, Neuss, Germany
^|| Universitätsklinikum Freiburg, Freiburg, Germany
^¶ CHRU de Lille, Lille, France
^# St. Johannes Hospital, Dortmund, Germany
^_** Multizentrische Klinische Studien, Berlin, Germany
GlaxoSmithKline Europe, London, United Kingdom

Manuscript received June 17, 2009; revised manuscript received August 10, 2009, accepted August 17, 2009.

^_* Reprint requests and correspondence: Prof. Dr. Uwe Zeymer, Herzzentrum Ludwigshafen, Bremserstrasse 79, D-67063 Ludwigshafen, Germany (Email: uwe.zeymer{at}t-online.de).

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)

Key Words: primary percutaneous coronary intervention • glycoprotein IIb/IIIa inhibitors • randomized trial • abciximab • eptifibatide

Abbreviations and Acronyms   ASA = acetylsalicylic acid   ECG = electrocardiogram   GP = glycoprotein   PCI = percutaneous coronary intervention   STEMI = ST-segment elevation myocardial infarction   STR = ST-segment resolution   TIMI = Thrombolysis In Myocardial Infarction

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