Bivalirudin for patients with acute coronary syndromes.
Publication/Presentation Date
11-23-2006
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
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].).
Volume
355
Issue
21
First Page
2203
Last Page
2216
ISSN
1533-4406
Published In/Presented At
Stone, G. W., McLaurin, B. T., Cox, D. A., Bertrand, M. E., Lincoff, A. M., Moses, J. W., White, H. D., Pocock, S. J., Ware, J. H., Feit, F., Colombo, A., Aylward, P. E., Cequier, A. R., Darius, H., Desmet, W., Ebrahimi, R., Hamon, M., Rasmussen, L. H., Rupprecht, H. J., Hoekstra, J., … ACUITY Investigators (2006). Bivalirudin for patients with acute coronary syndromes. The New England journal of medicine, 355(21), 2203–2216. https://doi.org/10.1056/NEJMoa062437
Disciplines
Medicine and Health Sciences
PubMedID
17124018
Department(s)
Department of Medicine
Document Type
Article