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Bristol-Myers Squibb Co And Pfizer Inc Announce Results Of Post-Hoc Subanalysis From Phase III ARISTOTLE Trial


Saturday, 31 Aug 2013 08:00am EDT 

Bristol-Myers Squibb Co and Pfizer Inc announced results of a post-hoc subanalysis from the Phase III ARISTOTLE trial. Patients with nonvalvular atrial fibrillation (NVAF) who are anticoagulated to reduce the risk of stroke often undergo procedures for which temporary discontinuation of the anticoagulant prior to and following the procedure is sometimes warranted. This subanalysis describes the overall rates of key post-procedural outcomes, such as stroke or systemic embolism and major bleeding, among Eliquis and warfarin patients who underwent a procedure during the ARISTOTLE trial, and examined any differences in post-procedural events according to whether or not study drug was interrupted. The results showed that in the 30-day period following a procedure, rates of clinical events (stroke or systemic embolism, major bleeding, and all-cause death) were comparable in the Eliquis and warfarin treatment arms. Among patients treated with Eliquis, event rates in the 30-day period following a procedure were similar whether Eliquis was stopped prior to the procedure or continued during the procedure. In patients taking warfarin, there was at least a twofold higher rate of major bleeding and death during the 30-day period following a procedure when warfarin was continued during the procedure compared to when warfarin was stopped prior to the procedure. 

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