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INTERVENTIONAL CARDIOLOGY

Lack of clopidogrel pretreatment effect on the relative efficacy of bivalirudin with provisional glycoprotein IIb/IIIa blockade compared to heparin with routine glycoprotein IIb/IIIa blockade

A REPLACE-2 substudy

Jacqueline Saw, MD^*, A. Michael Lincoff, MD^*,*, Walter DeSmet, MD, Amadeo Betriu, MD, Wolfgang Rutsch, MD, Robert G. Wilcox, MD^||, Neil S. Kleiman, MD^¶, Kathy Wolski, MPH^*, Eric J. Topol, MD^* REPLACE-2 Investigators^*

^* Department of Cardiovascular Medicine, the Cleveland Clinic Foundation, Cleveland, Ohio, USA
University Hospital Gasthuisberg, Leuven, Belgium
Hospital Clinic, University of Barcelona, Barcelona, Spain
Universitätsmedizin Berlin, Berlin, Germany
^|| University Hospital Nottingham, Nottingham, United Kingdom
^¶ Baylor College of Medicine, Houston, Texas, USA

Manuscript received February 25, 2004; revised manuscript received June 7, 2004, accepted June 14, 2004.

^* Reprint requests and correspondence: Dr. A. Michael Lincoff, The Cleveland Clinic Foundation, 9500 Euclid Avenue, Desk F25, Cleveland, Ohio 44195 (Email: lincofa{at}ccf.org).

OBJECTIVES: The purpose of this study was to assess if clopidogrel pretreatment affects the relative efficacy of bivalirudin versus heparin with glycoprotein (GP) IIb/IIIa blockade for percutaneous coronary interventions (PCI).

BACKGROUND: Although thienopyridine pretreatment may improve clinical outcomes with PCI, it is unknown if bivalirudin's efficacy compared with heparin is dependent upon such pretreatment.

METHODS: The Randomized Evaluation in Percutaneous coronary intervention Linking Angiomax to reduced Clinical Events (REPLACE-2) trial was a double-blind, triple-dummy, randomized-controlled trial comparing heparin plus routine GP IIb/IIIa blockade (heparin group) with bivalirudin plus provisional GP IIb/IIIa blockade (bivalirudin group) during PCI. The primary end point was a composite of death, myocardial infarction (MI), urgent revascularization at 30 days, and major in-hospital bleeding. The secondary end point was a 30-day composite of death, MI, and urgent revascularization. Clopidogrel pretreatment was encouraged (300 mg loading, 75 mg/day).

RESULTS: Of 6,010 patients enrolled, 5,893 received clopidogrel, with 85.8% in the bivalirudin and 84.6% in the heparin group receiving clopidogrel pretreatment. Bivalirudin (provisional GP IIb/IIIa blockade 7.2%) was noninferior to the heparin group for both primary and secondary end points. Clopidogrel pretreatment did not affect the relative efficacy of bivalirudin versus heparin with GP IIb/IIIa blockade, irrespective of pretreatment duration. Pretreatment was associated with significantly lower primary end point with bivalirudin (8.7% pretreatment vs. 12.9% no pretreatment, p = 0.007), and nonsignificantly with heparin (9.7% vs. 11.7%, respectively, p = 0.20). Multivariable models showed a trend toward lower primary and secondary end points with clopidogrel pretreatment.

CONCLUSIONS: Clopidogrel pretreatment at the doses and time administered in this trial did not influence the relative efficacy of bivalirudin versus heparin plus GP IIb/IIIa blockade for PCI. However, pretreatment was associated with a trend towards lower clinical events after PCI.

Abbreviations and Acronyms   GP = glycoprotein   MI = myocardial infarction   OR = odds ratio   PCI = percutaneous coronary intervention   REPLACE-2 = Randomized Evaluation in Percutaneous coronary intervention Linking Angiomax to reduced Clinical Events

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