Phase 3 Trial Update of Eliquis for Prevention of Stroke and Systemic Embolism in Nonvalvular Atrial Fibrillation

Bristol-Myers Squibb and Pfizer announced that the reductions in stroke or systemic embolism, major bleeding and mortality demonstrated with Eliquis (apixaban) compared to warfarin (Coumadin; Bristol-Myers Squibb) in the Phase 3 ARISTOTLE trial were consistent across a wide range of stroke and bleeding risk scores in patients with nonvalvular atrial fibrillation; these were results from a subanalysis from the study.

The ARISTOTLE study was designed to demonstrate the efficacy and safety of Eliquis vs. warfarin for the prevention of stroke or systemic embolism. In ARISTOTLE, 18,201 patients were randomized (9,120 patients to Eliquis and 9,081 to warfarin). ARISTOTLE was an active-controlled, randomized, double-blind, multi-national trial in patients with nonvalvular atrial fibrillation or atrial flutter, and at least one additional risk factor for stroke. Patients were randomized to treatment with Eliquis 5mg orally twice daily (or 2.5mg twice daily in selected patients, representing 4.7% of all patients) or warfarin (target INR range 2–3), and followed for a median of 1.8 years.

This subanalysis evaluated data from 18,201 patients in the trial, based on patients’ risk of stroke (CHADS₂ 1, 2, or ≥3, or CHA₂DS₂VASc 1, 2, or ≥3) or risk of bleeding (HAS-BLED 0-1, 2, or ≥3). Across prespecified and post-hoc analyses that evaluated CHADS₂, CHA₂DS₂VASc, or HAS-BLED categories, this subanalysis demonstrated that irrespective of a patient’s risk of stroke or bleeding, treatment with Eliquis resulted in a consistent reduction in stroke or systemic embolism and mortality, compared to warfarin. There were also consistently lower rates of major bleeding and of intracranial bleeding with Eliquis compared with warfarin across all evaluated CHADS₂, CHA₂DS₂VASc, and HAS-BLED score categories.

These findings are consistent with the primary results of the ARISTOTLE trial, which demonstrated that Eliquis, as compared with warfarin, significantly reduced the risk of stroke or systemic embolism, major bleeding, and mortality. In addition, results of this subanalysis showed that, in patients with nonvalvular atrial fibrillation, the reduction in intracranial bleeding with Eliquis compared to warfarin tended to be greater in patients who had the highest risk of bleeding (HAS-BLED score ≥3) than the reduction in patients with the lowest risk of bleeding (HAS-BLED score of 0–1).

Eliquis is an oral direct Factor Xa inhibitor.

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