Bivalirudin for patients with acute coronary syndromes

Gregg W. Stone, Brent T. McLaurin, David A. Cox, Michel E. Bertrand, A. Michael Lincoff, Jeffrey W. Moses, Harvey D. White, Stuart J. Pocock, James H. Ware, Frederick Feit, Antonio Colombo, Philip E. Aylward, Angel R. Cequier, Harald Darius, Walter Desmet, Ramin Ebrahimi, Martial Hamon, Lars H. Rasmussen, Hans Jürgen Rupprecht, James HoekstraRoxana Mehran, E. Magnus Ohman

Research output: Contribution to journalArticlepeer-review

Abstract

BACKGROUND: Current guidelines for patients with moderate- or high-risk acute coronary syndromes recommend an early invasive approach with concomitant antithrombotic therapy, including aspirin, clopidogrel, unfractionated or low-molecular-weight heparin, and glycoprotein IIb/IIIa inhibitors. We evaluated the role of thrombin-specific anticoagulation with bivalirudin in such patients. METHODS: We assigned 13,819 patients with acute coronary syndromes to one of three antithrombotic regimens: unfractionated heparin or enoxaparin plus a glycoprotein IIb/IIIa inhibitor, bivalirudin plus a glycoprotein IIb/IIIa inhibitor, or bivalirudin alone. The primary end points were a composite ischemia end point (death, myocardial infarction, or unplanned revascularization for ischemia), major bleeding, and the net clinical outcome, defined as the combination of composite ischemia or major bleeding. RESULTS: Bivalirudin plus a glycoprotein IIb/IIIa inhibitor, as compared with heparin plus a glycoprotein IIb/IIIa inhibitor, was associated with noninferior 30-day rates of the composite ischemia end point (7.7% and 7.3%, respectively), major bleeding (5.3% and 5.7%), and the net clinical outcome end point (11.8% and 11.7%). Bivalirudin alone, as compared with heparin plus a glycoprotein IIb/IIIa inhibitor, was associated with a noninferior rate of the composite ischemia end point (7.8% and 7.3%, respectively; P = 0.32; relative risk, 1.08; 95% confidence interval [CI], 0.93 to 1.24) and significantly reduced rates of major bleeding (3.0% vs. 5.7%; P

Original languageEnglish
Pages (from-to)2203-2216
Number of pages14
JournalNew England Journal of Medicine
Volume355
Issue number21
DOIs
Publication statusPublished - Nov 23 2006

ASJC Scopus subject areas

  • Medicine(all)

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