Which statement about the ARISTOTLE trial of apixaban versus warfarin in nonvalvular atrial fibrillation is correct?

• A Apixaban was non-inferior for stroke but caused more gastrointestinal bleeding than warfarin
• B Apixaban required routine coagulation monitoring to maintain its efficacy advantage
• C Apixaban matched warfarin on stroke but failed to show any mortality difference
• D Apixaban was superior to warfarin for stroke or systemic embolism, with less major bleeding and lower all-cause mortality ✓

Explanation

ARISTOTLE showed apixaban 5 mg twice daily (dose-reduced for age over 80, weight under 60 kg, or creatinine above 1.5 mg/dL) was superior to dose-adjusted warfarin in preventing stroke or systemic embolism, caused significantly less major bleeding including intracranial hemorrhage, and uniquely among the major DOAC trials also reduced all-cause mortality. No routine INR monitoring is needed, which eliminates option B immediately.

Reference: Harrison's Principles of Internal Medicine, 21st ed.

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Written and medically reviewed by the StethoPrep medical team.