1. Bivalirudin for Patients with Acute Coronary Syndromes
- Author
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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-Jürgen, Hoekstra, James, Mehran, Roxana, Ohman, E Magnus, ACUITY Investigators, and Universitat de Barcelona
- Subjects
Male ,Coronary ,Myocardial Ischemia ,Kaplan-Meier Estimate ,Gastroenterology ,Angina ,Coronary diseases ,80 and over ,Bivalirudin ,Angioplasty, Balloon, Coronary ,Coronary Artery Bypass ,Aged, 80 and over ,Medicine (all) ,Anticoagulant ,Antithrombin ,General Medicine ,Heparin ,Hirudins ,Middle Aged ,Recombinant Proteins ,Adult ,Aged ,Angina, Unstable ,Anticoagulants ,Drug Therapy, Combination ,Enoxaparin ,Female ,Hemorrhage ,Humans ,Peptide Fragments ,Platelet Glycoprotein GPIIb-IIIa Complex ,Combination ,Cardiology ,medicine.drug ,medicine.medical_specialty ,Bypass cardiopulmonary ,medicine.drug_class ,Heparina ,Ischemia ,Malalties coronàries ,Unstable ,Drug Therapy ,Internal medicine ,medicine ,business.industry ,Angioplasty ,medicine.disease ,Bypass cardiopulmonar ,Glycoprotein IIb/IIIa inhibitors ,Relative risk ,Anticoagulants (Medicina) ,Anticoagulants (Medicine) ,business ,Balloon - 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
- Published
- 2006