The ARISTOTLE study compared the efficacy and safety of anticoagulation therapy with direct oral factor Xa inhibitor apixaban versus warfarin in 18,201 atrial fibrillation patients at elevated risk of thromboembolic complications. In the apixaban group, the primary composite endpoint of stroke and systemic embolism was reduced by21%, the overall incidence of haemorrhagic stroke decreased by 49 %, and all-cause mortality dropped by 11%.
Apixaban was very well tolerated and was associated with reduction in any major category of bleeding complications.