Bivalirudin for patients with acute coronary syndromes.

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].).

• Authors: Gregg W Stone, Brent T McLaurin, David A Cox, Michel E Bertrand, A Michael Lincoff, Jeffrey W Moses, Harvey D White, Stuart J Pocock, James H Ware, Frederick Feit, Antonio Colombo, Philip E Aylward, Angel R Cequier, Harald Darius, Walter Desmet, Ramin Ebrahimi, Martial Hamon, Lars H Rasmussen, Hans-Jürgen Rupprecht, James Hoekstra, Roxana Mehran, E Magnus Ohman, ACUITY Investigators
• Journal: The New England journal of medicine (N Engl J Med) Vol. 355 Issue 21 Pg. 2203-16 (Nov 23 2006) ISSN: 1533-4406 [Electronic] United States
• PMID: 17124018 (Publication Type: Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: Copyright 2006 Massachusetts Medical Society.

Chemical References

• Anticoagulants
• Enoxaparin
• Hirudins
• Peptide Fragments
• Platelet Glycoprotein GPIIb-IIIa Complex
• Recombinant Proteins
• Heparin
• bivalirudin

Topics

• Adult
• Aged
• Aged, 80 and over
• Angina, Unstable (drug therapy, therapy)
• Angioplasty, Balloon, Coronary
• Anticoagulants (adverse effects, therapeutic use)
• Coronary Artery Bypass
• Drug Therapy, Combination
• Enoxaparin (therapeutic use)
• Female
• Hemorrhage (chemically induced)
• Heparin (therapeutic use)
• Hirudins (adverse effects)
• Humans
• Kaplan-Meier Estimate
• Male
• Middle Aged
• Myocardial Ischemia (epidemiology)
• Peptide Fragments (adverse effects, therapeutic use)
• Platelet Glycoprotein GPIIb-IIIa Complex (antagonists & inhibitors)
• Recombinant Proteins (adverse effects, therapeutic use)