Encouraging long-term results from the PROTECT AF trial comparing the Watchman left atrial appendage closure device to warfarin in atrial fibrillation patients were presented yesterday at the Heart Rhythm Society meeting in Denver.
Previously, the main results of the trial, published in the Lancet, demonstrated that the Watchman was noninferior to warfarin, but the total number of events in the trial was small. In addition, there were more safety problems, as might be expected, in the early days after implantation. The FDA required the company to perform a confirmatory trial. That trial, PREVAIL, has been the subject of considerable controversy. Now, long term followup of PROTECT AF may help better understand the risks and benefits of the device.
Vivek Reddy presented 4 year followup results from PROTECT AF. The primary efficacy endpoint– the combined rate of all stroke, cardiovascular or unexplained death and systemic embolism– occurred in 2.3% of the device group versus 3.8% of the warfarin group (RR 0.60, CI 0.41-1.05).