Transcript Slide 1

ARISTOTLE
Objectives
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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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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
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Ischemic or hemorrhagic stroke or systemic embolism
Primary Safety Outcome
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Rate of major ISTH bleeding
ARISTOTLE
Summary of Results
• As compared to warfarin, treatment with apixaban in patients
with 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 fewer
study drug discontinuations on apixaban
ARISTOTLE
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