OASIS-6

Organization to Assess Strategies for Ischemic Syndromes – 6 (2006) 

Condition

Prevention of reinfarction and death in patients with ST-segment elevation myocardial infarction (STEMI)

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Objective

To investigate the effect of fondaparinux in patients with STEMI when compared to usual care

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Trial design

Randomized, controlled, double-blind study; randomization was stratified by indication for the use of UFH: patients with no indication for UFH were enrolled in stratum 1, patients with indication for UFH in stratum 2

Active treatment (n=6036):

  • Stratum 1: fondaparinux 2.5 mg s.c. once daily up to 8 days (n=2823)
  • Stratum 2: fondaparinux 2.5 mg s.c. once daily up to 8 days plus UFH placebo (3213)

Control treatment (n=6056):

  • Stratum 1: fondaparinux placebo (n=2835)
  • Stratum 2: UFH bolus injection of 60 IU/kg followed by an infusion of 12 IU/kg per hour for 24 to 48 hours plus fondaparinux placebo for up to 8 days (n=3221)

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Endpoints

Primary efficacy endpoint: death or reinfarction at 30 days
Secondary efficacy endpoints: death or reinfarction at 9 days and at study end; all deaths, reinfarction, stroke
Safety endpoints: major bleeding

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Trial participants

12,092 patients (mean age 61 years) with acute STEMI

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Results

Primary outcome: The primary composite outcome of death or reinfarction was significantly reduced in the fondaparinux group compared to the placebo/UFH group at 9 days (7.4% vs. 8.9%), at 30 days (9.7% vs. 11.2%) and at the end of the study (3–6 months) (13.4% vs. 14.8%). The relative risk reduction was 17% at 9 days, 14% at day 30, and 12% at study end. Consistent reductions in both death and reinfarction were observed with fondaparinux at each of the 3 time points, with the reduction in deaths being statistically significant throughout
Safety outcome: At 9 days, the risk of major bleeding was 1.8% (107/6036) in patients given fondaparinux compared to 2.1% (130/6056) in patients treated with placebo or heparin. There was a tendency to fewer severe bleeds (79 for placebo/UFH vs. 61 for fondaparinux), with significantly fewer cardiac tamponade (48 vs. 28; p=0.02) with fondaparinux at 9 days

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Summary

Efficacy: Fondaparinux was superior to UFH in preventing death or reinfarction at 30 days and at 3 or 6 months
Safety: There was a non-significant trend towards fewer severe hemorrhages with fondaparinux compared to both control groups

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Reference

Yusuf S, Mehta SR, Chrolavicius S, Afzal R, Pogue J, Granger CB, Budaj A, Peters RJ, Bassand JP, Wallentin L, Joyner C, Fox KA; OASIS-6 Trial Group. Effects of fondaparinux on mortality and reinfarction in patients with acute ST-segment elevation myocardial infarction: the OASIS-6 randomized trial. J Am Med Ass 2006;295:1519-1530

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Corresponding author

Salim Yusuf, DPhil, FRCPC, FRSC, McMaster University, Room 252, McMaster Clinic, Hamilton General Hospital, 237 Barton Street East, Hamilton, Ontario, Canada L8L 2X2

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