I was struck by the significant difference in the primary end point of the study, particularly between the P2Y12 inhibitor/dabigatran 110mg (15.4%) and ASA/P2Y12/warfarin (25.7%) groups. There seems to be more to blame here than just the difference between dabigatran 110mg and warfarin. In the RE-LY trial, major and minor bleeding rates (similar end point) were 14.6% and 18.2% for dabigatran 110mg and warfarin, respectively. Acknowledging that comparing data from two similar but different studies has its limitations, what do people make of this difference? Is it due to differences in patient characteristics, the synergistic effect of these drugs in combination, both, or something else entirely?
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