RE-LY Post-hoc Subanalysis

1. RE-LYPost-hoc Subanalysis Background • The RE-LY trial compared dabigatran (110 mg BID and 150 mg BID) with warfarin in 18,113 patients with nonvalvular AF • The 110-mg dose of dabigatran was associated with SSE rates similar to those seen with warfarin but with a lower rate of major bleeding • The 150-mg dose of dabigatran was associated with a reduced SSE rate compared with warfarin but had a similar rate of major bleeding Subanalysis Primary Objective • Compare the efficacy and safety of each dose of dabigatran versus warfarin in patients with and without concomitant antiplatelet use to determine the effect on bleeding rates

2. RE-LYPost-hoc Subanalysis Summary of Subanalysis Findings • 6952 patients received concomitant antiplatelet therapy (mostly aspirin with or without clopidogrel) • SSE hazard ratio for patients in this subgroup was significantly lower for the 150-mg dabigatran dose compared with warfarin. The p-value for interaction (0.058) indicated evidence of attenuation in the benefit of dabigatran in the antiplatelet therapy group • SSE hazard ratio for the 110-mg dose group (receiving or not receiving antiplatelet therapy) was not significantly different from that of the warfarin group. The p-value for interaction (p=0.74) indicated no effect modification by concomitant antiplatelet therapy on the lower dose of dabigatran. Conclusions • The findings of this subanalysis correlated to those observed in the main trial whether or not concomitant antiplatelet therapy was administered