Bivalirudin for Patients with Acute Coronary Syndromes
Gregg W. Stone, M.D., Brent T. McLaurin, M.D., David A. Cox, M.D., Michel E. Bertrand, M.D., A. Michael Lincoff, M.D., Jeffrey W. Moses, M.D., Harvey D. White, M.D., Stuart J. Pocock, Ph.D., James H. Ware, Ph.D., Frederick Feit, M.D., Antonio Colombo, M.D., Philip E. Aylward, M.D., Angel R. Cequier, M.D., Harald Darius, M.D., Walter Desmet, M.D., Ramin Ebrahimi, M.D., Martial Hamon, M.D., Lars H. Rasmussen, M.D., Hans-Jürgen Rupprecht, M.D., James Hoekstra, M.D., Roxana Mehran, M.D., E. Magnus Ohman, M.D., for the ACUITY Investigators
Background Current guidelines for patients with moderate- orhigh-risk acute coronary syndromes recommend an early invasiveapproach with concomitant antithrombotic therapy, includingaspirin, clopidogrel, unfractionated or low-molecular-weightheparin, and glycoprotein IIb/IIIa inhibitors. We evaluatedthe role of thrombin-specific anticoagulation with bivalirudinin such patients.
Methods We assigned 13,819 patients with acute coronary syndromesto one of three antithrombotic regimens: unfractionated heparinor enoxaparin plus a glycoprotein IIb/IIIa inhibitor, bivalirudinplus 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 thecombination 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 compositeischemia 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 plusa glycoprotein IIb/IIIa inhibitor, was associated with a noninferiorrate of the composite ischemia end point (7.8% and 7.3%, respectively;P=0.32; relative risk, 1.08; 95% confidence interval [CI], 0.93to 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 coronarysyndromes who were undergoing invasive treatment with glycoproteinIIb/IIIa inhibitors, bivalirudin was associated with rates ofischemia and bleeding that were similar to those with heparin.Bivalirudin alone was associated with similar rates of ischemiaand significantly lower rates of bleeding. (ClinicalTrials.govnumber, 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.
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