Embed Size (px)
DESCRIPTION
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 - PowerPoint PPT Presentation
Citation preview
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
ARISTOTLE
