Peri-procedural was defined as the time starting 7 days before surgery and ending 30 days afterwards. During this period, 5.1% of Pradaxa patients and 4.6% of warfarin patients had major bleeds, a risk ratio of 1.09 (95% CI: [0.80, 1.48]), which was, of course, deemed non-statsig.
The purpose of this analysis from a marketing standpoint was presumably to show that the lack of a reversing agent does not put Pradaxa at a significant disadvantage to warfarin peri-procedurally.
Note: The FXa reversing agent being developed by Portola (#msg-76672265) will not work for Pradaxa, which is not an FXa inhibitor.
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