Please use this identifier to cite or link to this item: http://hdl.handle.net/2445/49765
Title: Bivalirudin for patients with acute coronary syndromes
Author: Stone, Gregg W.
McLaurin, Brent T.
Cox, David A.
Bertrand, Michel E.
Lincoff, A. Michael
Moses, Jeffrey W.
White, Harvey D.
Pocock, Stuart J.
Ware, James H.
Feit, Frederick
Colombo, Antonio
Aylward, Philip E.
Cequier Fillat, Àngel R.
Keywords: Malalties coronàries
Anticoagulants (Medicina)
Bypass cardiopulmonar
Heparina
Coronary diseases
Anticoagulants (Medicine)
Bypass cardiopulmonary
Heparin
Issue Date: 23-Nov-2006
Publisher: Massachusetts Medical Society
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<0.001; relative risk, 0.53; 95% CI, 0.43 to 0.65) and the net clinical outcome end point (10.1% vs. 11.7%; P = 0.02; relative risk, 0.86; 95% CI, 0.77 to 0.97). Conclusions: In patients with moderate- or high-risk acute coronary syndromes who were undergoing invasive treatment with glycoprotein IIb/IIIa inhibitors, bivalirudin was associated with rates of ischemia and bleeding that were similar to those with heparin. Bivalirudin alone was associated with similar rates of ischemia and significantly lower rates of bleeding. (ClinicalTrials.gov number, NCT00093158.)
Note: Reproducció del document publicat a: http://dx.doi.org/10.1056/NEJMoa062437
It is part of: New England Journal of Medicine, 2006, vol. 355, num. 21, p. 2203-2216
Related resource: http://dx.doi.org/10.1056/NEJMoa062437
URI: http://hdl.handle.net/2445/49765
ISSN: 0028-4793
Appears in Collections:Articles publicats en revistes (Ciències Clíniques)

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