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ARISTOTLE. Objectives Primary: test for noninferiority of apixaban, a novel oral direct factor Xa inhibitor, versus warfarin Secondary: test for superiority of apixaban with respect to the primary outcome and to the rates of major bleeding and death from any cause Study Design
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ARISTOTLE Objectives • Primary: test for noninferiority of apixaban, a novel oral direct factor Xa inhibitor, versus warfarin • Secondary: test for superiority of apixaban with respect to the primary outcome and to the rates of major bleeding and death from any cause Study Design • Randomized, multicenter, double-blind, double-dummy • 18,201 patients with AF and at least one additional risk factor for stroke, randomized to treatment with apixaban or warfarin Primary Outcome • Ischemic or hemorrhagic stroke or systemic embolism Primary Safety Outcome • Rate of major ISTH bleeding
ARISTOTLE Summary of Results • As compared to warfarin, treatment with apixaban in patientswith AF and at least one additional risk factor for stroke: • reduces stroke and systemic embolism by 21% • reduces major bleeding by 31% • reduces mortality by 11% • Consistent effects across all major subgroups and with fewerstudy drug discontinuations on apixaban
ARISTOTLE Conclusions • In patients with atrial fibrillation, apixaban is superior to warfarin in preventing stroke or systemic embolism, causes less bleeding, and results in lower mortality
