PREVAIL trial results were not presented during a late-breaking clinical trial session at the annual meeting of the American College of Cardiology as scheduled because of an embargo break by Boston Scientific, the device manufacturer.
According to the early released trial results, the WATCHMAN device for left atrial appendage closure met its primary safety endpoint. The risk for death, stroke, systemic embolism, and procedure or device-related complications requiring major intervention was just over 2%.
After Boston Scientific broke the embargo by releasing a press release announcing the trial results before the scheduled session at the meeting, the ACC pulled the presentation that was to be given by lead study investigator, Dr. David Holmes.
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