Fondaparinux significantly reduces the 30-day risk for a second myocardial infarction or death in patients with acute ST-segment elevation myocardial infarction, according to a presentation at the annual meeting of the American College of Cardiology.

International trials of medications such as unfractionated heparin (UFH), direct thrombin inhibitors, and enoxaparin have thus far failed to demonstrate reductions in the death rate, and bleeding is substantially increased when these agents are used with aspirin and thrombolytic therapy. There is a clear need for an effective, inexpensive, and safe antithrombotic agent for patients with ST-segment elevation myocardial infarction.

Salim Yusuf, DPhil, FRCPC, FRSC, of McMaster University and Hamilton Health Services, Ontario, Canada, and colleagues with the OASIS-6 Trial evaluated the effect of fondaparinux compared with standard antithrombotic therapy in patients with ST-elevation infarctions.

Outcomes (reinfarction and death) were assessed at 9 days, 30 days, and study end (minimum of 3 and maximum of 6 months). The study included 12,092 patients in 41 countries who were randomized to fondaparinux 2.5 mg once daily for up to 8 days or usual care (placebo in those in whom unfractionated heparin is not indicated or unfractionated heparin for up to 48 hours followed by placebo for up to 8 days in patients with ST-elevation infarctions).

The combined endpoint of death or reinfarction at 30 days was significantly reduced from 11.2 percent of 6,056 patients in the control group to 9.7 percent of 6,036 patients in the fondaparinux group, a risk reduction of 14 percent. These benefits were observed at 9 days (8.9 percent placebo vs. 7.4 percent fondaparinux), a 17 percent risk reduction; and at study end (14.8 percent placebo vs. 13.4 percent fondaparinux), a 12 percent reduction. Risk of death was significantly reduced throughout the study. However, there was no benefit in those undergoing primary percutaneous coronary intervention. There was a tendency to fewer severe bleeding events in the fondaparinux group.

“In summary, fondaparinux reduces mortality and reinfarction early, and this benefit persists long term,” the authors wrote. “… results from … OASIS-6 confirm the value and safety of fondaparinux as a simple and widely applicable antithrombotic therapy in a broad group of patients with acute coronary syndrome.”

The full report will appear in the April 5th issue of the Journal of the American Medical Association (JAMA).