Meta-analysis of efficacy and safety of the new anticoagulants versus warfarin in patients with atrial fibrillation.

OBJECTIVE: To assess the efficacy and safety of the new oral anticoagulants versus warfarin in patients with atrial fibrillation by the meta-analyses performed for 5 studies ARISTOTLE, ENGAGE AF-TIMI 48, RE-LY, ROCKET-AF, and J-ROCKET. METHODS: The events including primary efficacy endpoint (stroke and systemic embolism), ischemic stroke, hemorrhagic stroke, all-cause mortality, and myocardial infarction were used for efficacy analysis and those including major bleeding, intracranial hemorrhage, and gastrointestinal bleeding were used for safety analysis. Instead of combining both doses to 1 meta-analysis, the high-dose groups of RE-LY (150 mg twice daily) and ENGAGE AF-TIMI 48 (60 mg twice daily) were combined with the single dose studies ARISTOTLE, ROCKET-AF, and J-ROCKET. A separate meta-analysis was done for the low-dose groups of RE-LY (110 mg twice daily) and ENGAGE AF-TIMI 48 (30 mg twice daily). RESULTS: The high-dose regimen had better performance than low dose in efficacy. In addition, low-dose regimen demonstrated to significantly reduce the risk of hemorrhagic stroke, all-cause mortality, and intracranial hemorrhage. CONCLUSIONS: The new oral anticoagulants demonstrated promising alternatives to warfarin in prevention of stroke in patients with atrial fibrillation.