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ARISTOTLE TTR Subanalysis

ARISTOTLE TTR Subanalysis. Objective To assess whether the benefits of apixaban were consistent among centers that achieved similar TTRs Study Design Randomized, multicenter, double-blind, double-dummy

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ARISTOTLE TTR Subanalysis

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  1. ARISTOTLETTR Subanalysis Objective • To assess whether the benefits of apixaban were consistent among centers that achieved similar TTRs Study Design • Randomized, multicenter, double-blind, double-dummy • 18,201 patients with AF and at least one additional risk factor for stroke were randomized to treatment with apixaban versus warfarin Method • Each center’s TTR was calculated as the median of all subjects’ TTRs in warfarin-treated patients and then assigned as a measure of quality of INR control for all patients • Analyses were adjusted for differences in baseline variables with the potential to influence TTR and/or outcome

  2. ARISTOTLETTR Subanalysis Results • Consistent with the findings of the main trial results • When stratified by the centers’ TTRs, there was a directionally consistent reduction in the primary endpoint with apixaban compared with warfarin in each stratum

  3. ARISTOTLETTR Subanalysis Stroke and Systolic Embolism in Relation to Centers’ TTR

  4. ARISTOTLETTR Subanalysis • Investigators also found: • no significant interaction between efficacy and the quartile of center-based TTR • ISTH major bleeding was reduced in each center-based TTR stratum with apixaban • major or clinically relevant minor bleeding was also reduced with apixaban, with a more robust reduction at centers with lower TTRs and significant interaction • consistent reductions in mortality and the composite efficacy endpoint of SSE and MI with apixaban in each stratum, with no interaction, based on TTR • reduced incidence of hemorrhagic stroke and improved net clinical benefit with apixaban, neither of which was related to the quartile of center-based TTR.

  5. ARISTOTLETTR Subanalysis Bleeding in Relation to Centers’ TTR

  6. ARISTOTLETTR Subanalysis Conclusions • The benefit of apixaban over warfarin in preventing stroke, reducing bleeding, and improving survival appear consistent and not related to the quality of INR control at individual ARISTOTLE study centers • Investigators noted that a patient’s TTR may be modified by many factors • These results should be applied with caution by clinicians, especially when faced with individual patients who have been able to achieve excellent therapeutic control with warfarin

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