Fondaparinux reduced death or reinfarction in acute ST-segment elevation myocardial infarction.

M e t h o d s Design: Randomized placebo-controlled trial (Organization for the Assessment of Strategies for Ischemic Syndromes [OASIS-6]). Allocation: Unclear allocation concealment.* Blinding: Blinded (clinicians and patients).* Follow-up period: 3 to 6 months. Setting: 447 centers in 41 countries. Patients: 12 092 patients (mean age 62 y, 72% men) who presented with STEMI within 24 hours of pain onset (shortened to < 12 h after about 4300 patients had been enrolled). Exclusion criteria were contraindication to anticoagulants, receipt of oral anticoagulants, or creatinine levels > 265.2 mg/dL (3.0 mmol/L). Intervention: Patients were stratified by no indication for use of unfractionated heparin (UFH) or indication for UFH. Patients with no indication for UFH received fondaparinux, 2.5 mg subcutaneously (n = 2823), or placebo (n = 2835) for up to 8 days or hospital discharge. Patients for whom UFH was indicated received fondaparinux, 2.5 mg subcutaneously, plus UFH placebo (n = 3213) or fondaparinux placebo plus a bolus injection of UFH, 60 IU/kg, followed by an infusion of 12 IU/kg per hour for 24 to 48 hours (n = 3221). Outcomes: A composite endpoint of death or reinfarction at 30 days. Secondary outcomes were the composite endpoint assessed at 9 days and at study end (3 to 6 mo) and bleeding. Patient follow-up: 99.7% (intention-to-treat analysis).