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Previous Volume 355:2203-2216 November 23, 2006 Number 21 Next

	Full Text PDF PDA Full Text PowerPoint Slide Set Supplementary Material Editorial by Bittl, J. A. Letters Add to Personal Archive Add to Citation Manager Notify a Friend E-mail When Cited E-mail When Letters Appear PubMed Citation

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 [ClinicalTrials.gov] .)

Source Information

From Columbia University Medical Center and the Cardiovascular Research Foundation, New York (G.W.S., J.W.M., R.M.); AnMed Health, Anderson, SC (B.T.M.); Mid Carolina Cardiology, Charlotte, NC (D.A.C.); Hôpital Cardiologique, Lille, France (M.E.B.); Cleveland Clinic, Cleveland (A.M.L.); Auckland City Hospital, Auckland, New Zealand (H.D.W.); London School of Hygiene and Tropical Medicine, London (S.J.P.); Harvard University, Boston (J.H.W.); New York University School of Medicine, New York (F.F.); Ospedale San Raphael, Milan (A.C.); Flinders Medical Center, Adelaide, Australia (P.E.A.); Hospital Universitari de Bellvitge, Barcelona (A.R.C.); Krankenhaus Neukölln, Berlin (H.D.); University Hospital, Gasthuisberg, Leuven, Belgium (W.D.); UCLA and the Greater Los Angeles Veterans Affairs Medical Center, Los Angeles (R.E.); University Hospital, Normandy, France (M.H.); Aarhus University Hospital, Aalborg Hospital, Aalborg, Denmark (L.H.R.); GPR Klinikum Rüsselsheim, Rüsselsheim, Germany (H.-J.R.); Wake Forest University, Winston-Salem, NC (J.H.); and Duke University Medical Center, Durham, NC (E.M.O.).

Address reprint requests to Dr. Stone at Columbia University Medical Center, Cardiovascular Research Foundation, 111 E. 59th St., 11th Fl., New York, NY 10022, or at gs2184{at}columbia.edu.

Full Text of this Article

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Bivalirudin in Acute Coronary Syndromes
Sanmartin M., Bonvini R. F., Verin V., Righini M., Stone G. W., Hamon M., White H.
Extract | Full Text | PDF  
N Engl J Med 2007; 356:1069-1071, Mar 8, 2007. Correspondence

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