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REPLACE-2 Randomized Trial

A. Michael Lincoff, MD; John A. Bittl, MD; Robert A. Harrington, MD; Frederick Feit, MD; Neal S. Kleiman, MD; J. Daniel Jackman, MD; Ian J. Sarembock, MD; David J. Cohen, MD; Douglas Spriggs, MD; Ramin Ebrahimi, MD; Gadi Keren, MD; Jeffrey Carr, MD; Eric A. Cohen, MD; Amadeo Betriu, MD; Walter Desmet, MD; Dean J. Kereiakes, MD; Wolfgang Rutsch, MD; Robert G. Wilcox, MD; Pim J. de Feyter, MD; Alec Vahanian, MD; Eric J. Topol, MD; for the REPLACE-2 Investigators

JAMA. 2003;289:853-863.

Context  The direct thrombin inhibitor bivalirudin has been associated with better efficacy and less bleeding than heparin during coronary balloon angioplasty but has not been widely tested during contemporary percutaneous coronary intervention (PCI).

Objective  To determine the efficacy of bivalirudin, with glycoprotein IIb/IIIa (Gp IIb/IIIa) inhibition on a provisional basis for complications during PCI, compared with heparin plus planned Gp IIb/IIIa blockade with regard to protection from periprocedural ischemic and hemorrhagic complications.

Design, Setting, and Participants  The Randomized Evaluation in PCI Linking Angiomax to Reduced Clinical Events (REPLACE)–2 trial, a randomized, double-blind, active-controlled trial conducted among 6010 patients undergoing urgent or elective PCI at 233 community or referral hospitals in 9 countries from October 2001 through August 2002.

Interventions  Patients were randomly assigned to receive intravenous bivalirudin (0.75-mg/kg bolus plus 1.75 mg/kg per hour for the duration of PCI), with provisional Gp IIb/IIIa inhibition (n = 2999), or heparin (65-U/kg bolus) with planned Gp IIb/IIIa inhibition (abciximab or eptifibatide) (n = 3011). Both groups received daily aspirin and a thienopyridine for at least 30 days after PCI.

Main Outcome Measures  The primary composite end point was 30-day incidence of death, myocardial infarction, urgent repeat revascularization, or in-hospital major bleeding; the secondary composite end point was 30-day incidence of death, myocardial infarction, or urgent repeat revascularization.

Results  Provisional Gp IIb/IIIa blockade was administered to 7.2% of patients in the bivalirudin group. By 30 days, the primary composite end point had occurred among 9.2% of patients in the bivalirudin group vs 10.0% of patients in the heparin-plus-Gp IIb/IIIa group (odds ratio, 0.92; 95% confidence interval, 0.77-1.09; P = .32). The secondary composite end point occurred in 7.6% of patients in the bivalirudin vs 7.1% of patients in the heparin-plus-Gp IIb/IIIa groups (odds ratio, 1.09; 95% confidence interval 0.90-1.32; P = .40). Prespecified statistical criteria for noninferiority to heparin plus Gp IIb/IIIa were satisfied for both end points. In-hospital major bleeding rates were significantly reduced by bivalirudin (2.4% vs 4.1%; P<.001).

Conclusions  Bivalirudin with provisional Gp IIb/IIIa blockade is statistically not inferior to heparin plus planned Gp IIb/IIIa blockade during contemporary PCI with regard to suppression of acute ischemic end points and is associated with less bleeding.

Author Affiliations: Cleveland Clinic Foundation, Cleveland, Ohio (Drs Lincoff and Topol); Ocala Heart Institute, Munroe Regional Medical Center, Ocala, Fla (Dr Bittl); Duke Clinical Research Institute, Durham, NC (Dr Harrington); New York University School of Medicine, New York (Dr Feit); Baylor College of Medicine and Methodist Hospital, Houston, Tex (Dr Kleiman); Tyler Cardiovascular Consultants/Trinity Mother Frances Hospital, Tex (Dr Jackman); University of Virginia Health System, Charlottesville (Dr Sarembock); Beth Israel Deaconess Medical Center, Boston, Mass (Dr D. Cohen); Clearwater Cardiovascular Consultants, Clearwater, Fla (Dr Spriggs); West Los Angeles VA, Los Angeles, Calif (Dr Ebrahimi); Tel Aviv Sourasky Medical Center, Tel Aviv, Israel (Dr Keren); East Texas Medical Center, Tyler (Dr Carr); Sunnybrook & Women's College Health Sciences Center, Toronto, Ontario (Dr E. Cohen); University of Barcelona Hospital Clinic, Barcelona, Spain (Dr Betriu); University Hospital Gasthuisberg, Leuven, Belgium (Dr Desmet); the Lindner Center, Ohio Heart Health Center, Cincinnati (Dr Kereiakes); University Clinic Charite Berlin, Berlin, Germany (Dr Rutsch); University Hospital Nottingham, Nottingham, England (Dr Wilcox); University Hospital Dijkzigt, Rotterdam, the Netherlands (Dr de Feyter); and Hopital Bichat, Paris, France (Dr Vahanian).

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