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Efficacy and safety of fondaparinux versus enoxaparin in patients with acute coronary syndromes treated with glycoprotein IIb/IIIa inhibitors or thienopyridines: results from the OASIS 5 (Fifth Organization to Assess Strategies in Ischemic Syndromes) trial.

Publication ,  Journal Article
Jolly, SS; Faxon, DP; Fox, KAA; Afzal, R; Boden, WE; Widimsky, P; Steg, PG; Valentin, V; Budaj, A; Granger, CB; Joyner, CD; Chrolavicius, S ...
Published in: J Am Coll Cardiol
July 28, 2009

OBJECTIVES: This study sought to evaluate the relative safety and efficacy of fondaparinux and enoxaparin in patients with acute coronary syndromes (ACS) treated with glycoprotein (GP) IIb/IIIa inhibitors or thienopyridines. BACKGROUND: The OASIS 5 (Fifth Organization to Assess Strategies in Ischemic Syndromes) trial showed that fondaparinux reduced major bleeding by 50% compared with enoxaparin while preserving similar efficacy. Whether this benefit is consistent in the presence or absence of concurrent antiplatelet therapy with clopidogrel and GP IIb/IIIa inhibitors is unknown. METHODS: Patients with ACS (n = 20,078) were randomized as a part of the OASIS 5 trial to receive either fondaparinux or enoxaparin. The use of GP IIb/IIIa inhibitors or thienopyridines was at the discretion of the treating physician. A Cox proportional hazard model was used to compare outcomes. RESULTS: Of the 20,078 patients randomized, 3,630 patients received GP IIb/IIIa and 13,531 received thienopyridines. There was a 40% reduction in major bleeding with fondaparinux compared with enoxaparin in those treated with GP IIb/IIIa (5.2% vs. 8.3%, hazard ratio [HR]: 0.61, p < 0.001). A similar reduction was found in those treated with thienopyridines (3.4% vs. 5.4%, HR: 0.62, p < 0.001). Ischemic events were similar between the groups, resulting in a superior net clinical outcome (death, myocardial infarction, refractory ischemia, or major bleeding) favoring fondaparinux (GP IIb/IIIa subgroup 14.8% vs. 18.9%, HR: 0.77, p = 0.001 and thienopyridines subgroup 11.0% vs. 13.2%, HR: 0.82, p < 0.001). CONCLUSIONS: In patients receiving GP IIb/IIIa inhibitors or thienopyridines, fondaparinux reduces major bleeding and improves net clinical outcome compared with enoxaparin.

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Published In

J Am Coll Cardiol

DOI

EISSN

1558-3597

Publication Date

July 28, 2009

Volume

54

Issue

5

Start / End Page

468 / 476

Location

United States

Related Subject Headings

  • Treatment Outcome
  • Pyridines
  • Polysaccharides
  • Platelet Glycoprotein GPIIb-IIIa Complex
  • Platelet Aggregation Inhibitors
  • Male
  • Humans
  • Fondaparinux
  • Female
  • Enoxaparin
 

Citation

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Jolly, S. S., Faxon, D. P., Fox, K. A. A., Afzal, R., Boden, W. E., Widimsky, P., … Mehta, S. R. (2009). Efficacy and safety of fondaparinux versus enoxaparin in patients with acute coronary syndromes treated with glycoprotein IIb/IIIa inhibitors or thienopyridines: results from the OASIS 5 (Fifth Organization to Assess Strategies in Ischemic Syndromes) trial. J Am Coll Cardiol, 54(5), 468–476. https://doi.org/10.1016/j.jacc.2009.03.062
Jolly, Sanjit S., David P. Faxon, Keith A. A. Fox, Rizwan Afzal, William E. Boden, Petr Widimsky, P Gabriel Steg, et al. “Efficacy and safety of fondaparinux versus enoxaparin in patients with acute coronary syndromes treated with glycoprotein IIb/IIIa inhibitors or thienopyridines: results from the OASIS 5 (Fifth Organization to Assess Strategies in Ischemic Syndromes) trial.J Am Coll Cardiol 54, no. 5 (July 28, 2009): 468–76. https://doi.org/10.1016/j.jacc.2009.03.062.
Jolly SS, Faxon DP, Fox KAA, Afzal R, Boden WE, Widimsky P, Steg PG, Valentin V, Budaj A, Granger CB, Joyner CD, Chrolavicius S, Yusuf S, Mehta SR. Efficacy and safety of fondaparinux versus enoxaparin in patients with acute coronary syndromes treated with glycoprotein IIb/IIIa inhibitors or thienopyridines: results from the OASIS 5 (Fifth Organization to Assess Strategies in Ischemic Syndromes) trial. J Am Coll Cardiol. 2009 Jul 28;54(5):468–476.
Journal cover image

Published In

J Am Coll Cardiol

DOI

EISSN

1558-3597

Publication Date

July 28, 2009

Volume

54

Issue

5

Start / End Page

468 / 476

Location

United States

Related Subject Headings

  • Treatment Outcome
  • Pyridines
  • Polysaccharides
  • Platelet Glycoprotein GPIIb-IIIa Complex
  • Platelet Aggregation Inhibitors
  • Male
  • Humans
  • Fondaparinux
  • Female
  • Enoxaparin