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Efficacy and safety of fondaparinux versus enoxaparin in patients with acute coronary syndromes undergoing percutaneous coronary intervention: results from the OASIS-5 trial.

Publication ,  Journal Article
Mehta, SR; Granger, CB; Eikelboom, JW; Bassand, J-P; Wallentin, L; Faxon, DP; Peters, RJG; Budaj, A; Afzal, R; Chrolavicius, S; Fox, KAA; Yusuf, S
Published in: J Am Coll Cardiol
October 30, 2007

OBJECTIVES: This study reports a prospectively planned analysis of patients with acute coronary syndrome who underwent early percutaneous coronary intervention (PCI) in the OASIS-5 (Fifth Organization to Assess Strategies in Ischemic Syndromes) trial. BACKGROUND: In the OASIS-5 trial, fondaparinux was similar to enoxaparin for short-term efficacy, but reduced major bleeding by one-half and 30-day mortality by 17%. METHODS: The OASIS-5 trial was a double-blind, randomized comparison of fondaparinux and enoxaparin in 20,078 patients with acute coronary syndrome. A total of 12,715 patients underwent heart catheterization during the initial hospitalization, and 6,238 patients underwent PCI. In the fondaparinux group, intravenous fondaparinux was given for PCI. In the enoxaparin group, no additional anticoagulant was given if PCI was <6 h from last subcutaneous dose, and additional intravenous unfractionated heparin (UFH) was given if PCI was >6 h. RESULTS: Fondaparinux compared with enoxaparin reduced major bleeding by more than one-half (2.4% vs. 5.1%, hazard ratio [HR] 0.46, p < 0.00001) at day 9, with similar rates of ischemic events, resulting in superior net clinical benefit (death, myocardial infarction, stroke, major bleeding: 8.2% vs. 10.4%, HR 0.78, p = 0.004). Fondaparinux reduced major bleeding 48 h after PCI irrespective of whether PCI was performed <6 h of the last enoxaparin dose (1.6% vs. 3.8%, HR 0.42, p < 0.0001) or >6 h when UFH was given (1.3% vs. 3.4%, HR 0.39, p < 0.0001). Catheter thrombus was more common in patients receiving fondaparinux (0.9%) than enoxaparin alone (0.4%), but was largely prevented by using UFH at the time of PCI, without any increase in bleeding. CONCLUSIONS: Upstream therapy with fondaparinux compared with upstream enoxaparin substantially reduces major bleeding while maintaining efficacy, resulting in superior net clinical benefit. The use of standard UFH in place of fondaparinux at the time of PCI seems to prevent angiographic complications, including catheter thrombus, without compromising the benefits of upstream fondaparinux.

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Published In

J Am Coll Cardiol

DOI

EISSN

1558-3597

Publication Date

October 30, 2007

Volume

50

Issue

18

Start / End Page

1742 / 1751

Location

United States

Related Subject Headings

  • Treatment Outcome
  • Time Factors
  • Syndrome
  • Polysaccharides
  • Myocardial Infarction
  • Middle Aged
  • Male
  • Humans
  • Heparin
  • Fondaparinux
 

Citation

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Mehta, S. R., Granger, C. B., Eikelboom, J. W., Bassand, J.-P., Wallentin, L., Faxon, D. P., … Yusuf, S. (2007). Efficacy and safety of fondaparinux versus enoxaparin in patients with acute coronary syndromes undergoing percutaneous coronary intervention: results from the OASIS-5 trial. J Am Coll Cardiol, 50(18), 1742–1751. https://doi.org/10.1016/j.jacc.2007.07.042
Mehta, Shamir R., Christopher B. Granger, John W. Eikelboom, Jean-Pierre Bassand, Lars Wallentin, David P. Faxon, Ron J. G. Peters, et al. “Efficacy and safety of fondaparinux versus enoxaparin in patients with acute coronary syndromes undergoing percutaneous coronary intervention: results from the OASIS-5 trial.J Am Coll Cardiol 50, no. 18 (October 30, 2007): 1742–51. https://doi.org/10.1016/j.jacc.2007.07.042.
Mehta SR, Granger CB, Eikelboom JW, Bassand J-P, Wallentin L, Faxon DP, et al. Efficacy and safety of fondaparinux versus enoxaparin in patients with acute coronary syndromes undergoing percutaneous coronary intervention: results from the OASIS-5 trial. J Am Coll Cardiol. 2007 Oct 30;50(18):1742–51.
Mehta, Shamir R., et al. “Efficacy and safety of fondaparinux versus enoxaparin in patients with acute coronary syndromes undergoing percutaneous coronary intervention: results from the OASIS-5 trial.J Am Coll Cardiol, vol. 50, no. 18, Oct. 2007, pp. 1742–51. Pubmed, doi:10.1016/j.jacc.2007.07.042.
Mehta SR, Granger CB, Eikelboom JW, Bassand J-P, Wallentin L, Faxon DP, Peters RJG, Budaj A, Afzal R, Chrolavicius S, Fox KAA, Yusuf S. Efficacy and safety of fondaparinux versus enoxaparin in patients with acute coronary syndromes undergoing percutaneous coronary intervention: results from the OASIS-5 trial. J Am Coll Cardiol. 2007 Oct 30;50(18):1742–1751.
Journal cover image

Published In

J Am Coll Cardiol

DOI

EISSN

1558-3597

Publication Date

October 30, 2007

Volume

50

Issue

18

Start / End Page

1742 / 1751

Location

United States

Related Subject Headings

  • Treatment Outcome
  • Time Factors
  • Syndrome
  • Polysaccharides
  • Myocardial Infarction
  • Middle Aged
  • Male
  • Humans
  • Heparin
  • Fondaparinux