ARISTOTLE

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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

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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

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ARISTOTLE
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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