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Bivalirudin for patients with acute coronary syndromes.

Publication ,  Journal Article
Stone, GW; McLaurin, BT; Cox, DA; Bertrand, ME; Lincoff, AM; Moses, JW; White, HD; Pocock, SJ; Ware, JH; Feit, F; Colombo, A; Aylward, PE ...
Published in: N Engl J Med
November 23, 2006

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].).

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Published In

N Engl J Med

DOI

EISSN

1533-4406

Publication Date

November 23, 2006

Volume

355

Issue

21

Start / End Page

2203 / 2216

Location

United States

Related Subject Headings

  • Recombinant Proteins
  • Platelet Glycoprotein GPIIb-IIIa Complex
  • Peptide Fragments
  • Myocardial Ischemia
  • Middle Aged
  • Male
  • Kaplan-Meier Estimate
  • Humans
  • Hirudins
  • Heparin
 

Citation

APA
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ICMJE
MLA
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Stone, G. W., McLaurin, B. T., Cox, D. A., Bertrand, M. E., Lincoff, A. M., Moses, J. W., … ACUITY Investigators, . (2006). Bivalirudin for patients with acute coronary syndromes. N Engl J Med, 355(21), 2203–2216. https://doi.org/10.1056/NEJMoa062437
Stone, Gregg W., Brent T. McLaurin, David A. Cox, Michel E. Bertrand, A Michael Lincoff, Jeffrey W. Moses, Harvey D. White, et al. “Bivalirudin for patients with acute coronary syndromes.N Engl J Med 355, no. 21 (November 23, 2006): 2203–16. https://doi.org/10.1056/NEJMoa062437.
Stone GW, McLaurin BT, Cox DA, Bertrand ME, Lincoff AM, Moses JW, et al. Bivalirudin for patients with acute coronary syndromes. N Engl J Med. 2006 Nov 23;355(21):2203–16.
Stone, Gregg W., et al. “Bivalirudin for patients with acute coronary syndromes.N Engl J Med, vol. 355, no. 21, Nov. 2006, pp. 2203–16. Pubmed, doi:10.1056/NEJMoa062437.
Stone GW, McLaurin BT, Cox DA, Bertrand ME, Lincoff AM, Moses JW, White HD, Pocock SJ, Ware JH, Feit F, Colombo A, Aylward PE, Cequier AR, Darius H, Desmet W, Ebrahimi R, Hamon M, Rasmussen LH, Rupprecht H-J, Hoekstra J, Mehran R, Ohman EM, ACUITY Investigators. Bivalirudin for patients with acute coronary syndromes. N Engl J Med. 2006 Nov 23;355(21):2203–2216.

Published In

N Engl J Med

DOI

EISSN

1533-4406

Publication Date

November 23, 2006

Volume

355

Issue

21

Start / End Page

2203 / 2216

Location

United States

Related Subject Headings

  • Recombinant Proteins
  • Platelet Glycoprotein GPIIb-IIIa Complex
  • Peptide Fragments
  • Myocardial Ischemia
  • Middle Aged
  • Male
  • Kaplan-Meier Estimate
  • Humans
  • Hirudins
  • Heparin