Presentation on theme: "ARISTOTLE TTR Subanalysis"— Presentation transcript:
1 ARISTOTLE TTR Subanalysis ObjectiveTo assess whether the benefits of apixaban were consistent among centers that achieved similar TTRsStudy DesignRandomized, multicenter, double-blind, double-dummy18,201 patients with AF and at least one additional risk factor for stroke were randomized to treatment with apixaban versus warfarinMethodEach 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 patientsAnalyses were adjusted for differences in baseline variables with the potential to influence TTR and/or outcome
2 ARISTOTLE TTR Subanalysis ResultsConsistent with the findings of the main trial resultsWhen stratified by the centers’ TTRs, there was a directionally consistent reduction in the primary endpoint with apixaban compared with warfarin in each stratum
3 ARISTOTLE TTR Subanalysis Stroke and Systolic Embolism in Relation to Centers’ TTR
4 ARISTOTLE TTR Subanalysis Investigators also found:no significant interaction between efficacy and the quartile of center-based TTRISTH major bleeding was reduced in each center-based TTR stratum with apixabanmajor or clinically relevant minor bleeding was also reduced with apixaban, with a more robust reduction at centers with lower TTRs and significant interactionconsistent reductions in mortality and the composite efficacy endpoint of SSE and MI with apixaban in each stratum, with no interaction, based on TTRreduced incidence of hemorrhagic stroke and improved net clinical benefit with apixaban, neither of which was related to the quartile of center-based TTR.
5 ARISTOTLE TTR Subanalysis Bleeding in Relation to Centers’ TTR
6 ARISTOTLE TTR Subanalysis ConclusionsThe 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 centersInvestigators noted that a patient’s TTR may be modified by many factorsThese 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