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" ... Primary outcome: 3.5% with continued warfarin versus 16% with heparin bridging (RR 0.19, CI 0.10-0.36, p<0.001). ... "
" ... The panel wrestled throughout the day with a fundamental problem: combined data from the two clinical trials, PROTECT AF and PREVAIL, showed clearly that Watchman was not equivalent to warfarin for the chief indication of stroke reduction in the study population. Furthermore, in clinical trials patients who received the Watchman were compared to patients taking warfarin. But there was a strong sentiment among panel members that the device should be available only to AF patients who are eligible for warfarin but don't want to take it and, perhaps also, for patients who are not eligible for warfarin therapy. The problem, of course, is that neither of these patient groups was studied in the clinical trials. ... "