What is the efficacy and safety of apixaban (Eliquis) use in patients with atrial fibrillation (Afib) (AF)?

Updated: Nov 18, 2019
  • Author: Lawrence Rosenthal, MD, PhD, FACC, FHRS; Chief Editor: Jeffrey N Rottman, MD  more...
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Answer

Another factor Xa inhibitor, apixaban (Eliquis), was approved by the FDA in December 2012. Approval was based on two clinical trials: ARISTOTLE (Apixaban for Reduction in Stroke and Other Thromboembolic Events in AF) and AVERROES (Apixaban Versus Acetylsalicylic Acid [ASA] to Prevent Stroke in AF Patients Who Have Failed or Are Unsuitable for Vitamin K Antagonist Treatment). (Patients with serum creatinine of 2.5 mL/dL or greater were excluded from both apixaban trials.)

The ARISTOTLE  trial compared apixaban with warfarin for the prevention of stroke or systemic embolism in 18,201 patients with AF and found that apixaban was superior to warfarin in preventing stroke or systemic embolism, caused less bleeding, and resulted in lower mortality. [83, 84, 85]

The AVERROES trial, which compared apixaban with aspirin in 5599 patients with AF for whom warfarin therapy was considered unsuitable, was stopped early (after 1.1 year) after an interim analysis because apixaban showed a significant reduction in stroke and systemic embolism compared with aspirin. [86] A modest increase of major bleeding was observed with apixaban compared with aspirin. [86]


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