Bivalirudin for patients with acute coronary syndromes

被引:1103
作者
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, Angel R.
Darius, Harald
Desmet, Walter
Ebrahimi, Ramin
Hamon, Martial
Rasmussen, Lars H.
Rupprecht, Hans-Juergen
Hoekstra, James
Mehran, Roxana
Ohman, E. Magnus
机构
[1] Columbia Univ, Med Ctr, Cardiovasc Res Fdn, New York, NY 10022 USA
[2] AnMed Hlth, Anderson, SC USA
[3] Mid Carolina Cardiol, Charlotte, NC USA
[4] Hop Cardiol, F-59037 Lille, France
[5] Cleveland Clin, Cleveland, OH 44106 USA
[6] Auckland City Hosp, Auckland, New Zealand
[7] London Sch Hyg & Trop Med, London WC1, England
[8] Harvard Univ, Boston, MA 02115 USA
[9] NYU, Sch Med, New York, NY USA
[10] Osped San Raphael, Milan, Italy
[11] Flinders Med Ctr, Adelaide, SA, Australia
[12] Hosp Univ Bellvitge, Barcelona, Spain
[13] Krankenhaus Neukolln, Berlin, Germany
[14] Univ Hosp Gasthuisberg, B-3000 Louvain, Belgium
[15] Univ Calif Los Angeles, Los Angeles, CA USA
[16] Greater Los Angeles Vet Affairs Med Ctr, Los Angeles, CA USA
[17] Univ Hosp, Normandy, France
[18] Aarhus Univ Hosp, Aalborg Hosp, Aalborg, Denmark
[19] GPR Klinikum Russelsheim, Russelsheim, Germany
[20] Wake Forest Univ, Winston Salem, NC 27109 USA
[21] Duke Univ, Med Ctr, Durham, NC USA
关键词
D O I
10.1056/NEJMoa062437
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
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.).
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页码:2203 / 2216
页数:14
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