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Randomized evaluation of the safety and efficacy of enoxaparin versus unfractionated heparin in high-risk patients with non-ST-segment elevation acute coronary syndromes receiving the glycoprotein IIb/IIIa inhibitor eptifibatide.

Publication ,  Journal Article
Goodman, SG; Fitchett, D; Armstrong, PW; Tan, M; Langer, A ...
Published in: Circulation
January 21, 2003

BACKGROUND: Current pharmacotherapeutic options for high-risk non-ST-segment elevation acute coronary syndrome patients include aspirin, clopidogrel, heparin, and platelet glycoprotein IIb/IIIa inhibition. A key issue of uncertainty is the safety and efficacy of combination glycoprotein IIb/IIIa inhibitor and low-molecular-weight heparin therapy. METHODS AND RESULTS: We randomized 746 patients with rest ischemic discomfort within 24 hours after the onset of symptoms and ST-segment deviation and/or elevation of serum cardiac markers to receive open-label enoxaparin (1 mg/kg subcutaneously twice daily) or unfractionated heparin (70-U/kg bolus; 15 U x kg(-1) x h(-1) infusion, titrated to an activated partial thromboplastin time of 1.5 to 2 times control) for 48 hours. All patients received aspirin and eptifibatide (180- microg/kg bolus; 2 microg x kg(-1) x min(-1) infusion). Major non-coronary artery bypass surgery-related bleeding at 96 hours (primary safety outcome) was significantly lower among enoxaparin-treated patients than among heparin-treated patients (1.8% versus 4.6%, P=0.03). Minor bleeding was more frequent in the enoxaparin group (30.3% versus 20.8%, P=0.003). Patients in the enoxaparin group were less likely to experience ischemia as detected by continuous ECG evaluation (primary efficacy outcome) during the initial (14.3% versus 25.4%, P=0.0002) and subsequent (12.7% versus 25.9%, P<0.0001) 48-hour monitoring periods. Death or myocardial infarction at 30 days was significantly lower in the enoxaparin group (5% versus 9%, P=0.031). CONCLUSIONS: When aspirin and eptifibatide are used in high-risk non-ST-segment elevation acute coronary syndrome patients, enoxaparin improves outcomes (determined on the basis of better safety and efficacy) compared with currently recommended unfractionated heparin therapy and provides a useful novel alternative therapeutic strategy.

Duke Scholars

Published In

Circulation

DOI

EISSN

1524-4539

Publication Date

January 21, 2003

Volume

107

Issue

2

Start / End Page

238 / 244

Location

United States

Related Subject Headings

  • Treatment Outcome
  • Survival Analysis
  • Secondary Prevention
  • Platelet Glycoprotein GPIIb-IIIa Complex
  • Peptides
  • Myocardial Ischemia
  • Monitoring, Physiologic
  • Middle Aged
  • Male
  • Humans
 

Citation

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Goodman, S. G., Fitchett, D., Armstrong, P. W., Tan, M., Langer, A., & Integrilin and Enoxaparin Randomized Assessment of Acute Coronary Syndrome Treatment (INTERACT) Trial Investigators, . (2003). Randomized evaluation of the safety and efficacy of enoxaparin versus unfractionated heparin in high-risk patients with non-ST-segment elevation acute coronary syndromes receiving the glycoprotein IIb/IIIa inhibitor eptifibatide. Circulation, 107(2), 238–244. https://doi.org/10.1161/01.cir.0000050144.67910.13
Goodman, Shaun G., David Fitchett, Paul W. Armstrong, Mary Tan, Anatoly Langer, and Anatoly Integrilin and Enoxaparin Randomized Assessment of Acute Coronary Syndrome Treatment (INTERACT) Trial Investigators. “Randomized evaluation of the safety and efficacy of enoxaparin versus unfractionated heparin in high-risk patients with non-ST-segment elevation acute coronary syndromes receiving the glycoprotein IIb/IIIa inhibitor eptifibatide.Circulation 107, no. 2 (January 21, 2003): 238–44. https://doi.org/10.1161/01.cir.0000050144.67910.13.
Goodman SG, Fitchett D, Armstrong PW, Tan M, Langer A, Integrilin and Enoxaparin Randomized Assessment of Acute Coronary Syndrome Treatment (INTERACT) Trial Investigators. Randomized evaluation of the safety and efficacy of enoxaparin versus unfractionated heparin in high-risk patients with non-ST-segment elevation acute coronary syndromes receiving the glycoprotein IIb/IIIa inhibitor eptifibatide. Circulation. 2003 Jan 21;107(2):238–44.
Goodman SG, Fitchett D, Armstrong PW, Tan M, Langer A, Integrilin and Enoxaparin Randomized Assessment of Acute Coronary Syndrome Treatment (INTERACT) Trial Investigators. Randomized evaluation of the safety and efficacy of enoxaparin versus unfractionated heparin in high-risk patients with non-ST-segment elevation acute coronary syndromes receiving the glycoprotein IIb/IIIa inhibitor eptifibatide. Circulation. 2003 Jan 21;107(2):238–244.

Published In

Circulation

DOI

EISSN

1524-4539

Publication Date

January 21, 2003

Volume

107

Issue

2

Start / End Page

238 / 244

Location

United States

Related Subject Headings

  • Treatment Outcome
  • Survival Analysis
  • Secondary Prevention
  • Platelet Glycoprotein GPIIb-IIIa Complex
  • Peptides
  • Myocardial Ischemia
  • Monitoring, Physiologic
  • Middle Aged
  • Male
  • Humans