- Question
- Does early fondaparinux, a factor Xa inhibitor, reduce death and reinfarction in patients with acute ST-segment elevation myocardial infarction (STEMI), including those not receiving reperfusion?
- Design
- Randomized, double-blind trial of 12092 patients from 447 hospitals in 41 countries, enrolled between September 2003 and January 2006. Randomization was stratified by whether unfractionated heparin (UFH) was indicated; final follow-up was at 3 or 6 months.
- Population
- Patients with STEMI, both with reperfusion (thrombolysis or primary PCI) and without it. Stratum 1 included those with no indication for UFH and stratum 2 those with an indication for UFH.
- Intervention
- Fondaparinux 2.5 mg once daily (first dose intravenous, then subcutaneous) for up to 8 days or until discharge.
- Control
- Placebo in stratum 1; in stratum 2, UFH for 24-48 hours followed by placebo for up to 8 days.
- Primary outcome
- Composite of death or reinfarction at 30 days.
- Results
- The primary outcome occurred in 677 patients (11.2%) in the control group and 585 (9.7%) in the fondaparinux group (HR 0.86; 95% CI 0.77-0.96; P = .008), an absolute risk reduction of 1.5%. There was no benefit in patients undergoing primary PCI, and mortality was significantly reduced throughout the study.
- Safety
- There was a trend toward fewer severe bleeds with fondaparinux (79 with placebo vs 61; P = .13) and significantly fewer cases of cardiac tamponade (48 vs 28; P = .02) at 9 days, with no increase in bleeding or stroke.
- Conclusion
- In STEMI, particularly in patients not undergoing primary PCI, fondaparinux reduced mortality and reinfarction without increasing bleeding.
- Why it matters
- It showed that a fixed-dose, once-daily anticoagulant could improve outcomes across a broad range of STEMI patients, and it highlighted that its benefit depends on the reperfusion strategy.
Card generated automatically with AI from the abstract of the original publication and the trial registry; every figure was checked against those sources. It may contain errors: verify the data at the source before using it for clinical decisions.
Generated on October 10, 2026