New Eliquis® (apixaban) Post-hoc Subanalysis Of The Phase III ARISTOTLE Trial Demonstrated That Within 30 Days Of A Procedure, Stroke Or Systemic Embolism And Major Bleeding Were Uncommon
Bristol-Myers Squibb Company (NYSE: BMY) and Pfizer Inc. (NYSE: PFE) today 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. This subanalysis was presented today at the ESC Congress 2013, organized by the European Society of Cardiology, in Amsterdam, The Netherlands.
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.
“For patients with NVAF who undergo procedures, the rate of anticoagulation-related adverse events appears to be similar whether the patient is chronically anticoagulated with apixaban or warfarin,” said study lead investigator Dr. Renato Lopes of Duke University Medical Center in Durham, North Carolina. “For NVAF patients for whom interruption of anticoagulation for a procedure is required, these findings suggest that using apixaban instead of warfarin, which is more challenging to stop and restart, may simplify the management of peri-operative anticoagulation in NVAF patients.”
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