FOndaparinux in ST Elevation Myocardial Infarction. Safety and Efficacy Trial Evaluating Fondaparinux Use in a Broad Range of Patients With ST Segment Elevation Acute MI
To determine the efficacy and safety of fondaparinux (Arixtra) in preventing death and repeat heart attacks and their complications in ST-segment elevation acute coronary syndromes. The trial showed that In patients with STEMI, particularly those not undergoing primary percutaneous coronary intervention, fondaparinux significantly reduces mortality and reinfarction without increasing bleeding and strokes. These findings in conjunction with the results of the OASIS –5 trial led to widespread use of fondaparinux in ACs.
Randomized, double-blind, active control, parallel group design, safety/efficacy study.
Primary outcome: composite of death or recurrent myocardial infarction (MI) up to day 30. These outcomes were also assessed at 9 days and at study end (minimum of 3 and maximum of 6 months). The main safety outcome was severe bleeding and the balance of benefits and risks was assessed using the composite outcome of death, reinfarction, and severe bleeding at each of the above time points.
Salim Yusuf, Shamir Mehta Project Officer
Brandi Meeks, Joanne Willcox, Craig Horsman