In an extremely unusual move, only days before the scheduled presentation of the main results of a highly-anticipated late-breaking clinical trial, the trial’s sponsor announced that the full results of the trial would not be presented. Instead, the company said the principal investigator would present only one of three of the trial’s primary endpoints, the acute procedural safety results. But, it appears, there is still a chance that the full results of the trial will end up being presented.
In 2010 the FDA refused to approve the Watchman, Boston Scientific’s left atrial appendage closure device for patients with nonvalvular atrial fibrillation. Although the earlier pivotal PROTECT AF trial received a positive, though lukewarm endorsement from the FDA’s Circulatory System Devices Panel, the FDA ultimately said Boston Scientific needed to perform an additional trial. The PREVAIL trial was intended to confirm the safety and efficacy of the Watchman left atrial appendage closure device.
PREVAIL was arguably the most high-profile trial scheduled for presentation at the American College of Cardiology scientific sessions starting this Saturday in San Francisco. On Monday, however, Boston Scientific, in a press release listing its presentations at the ACC, announced that the principal investigator of the trial, David Holmes, would only “present the acute procedural safety results.”