Evolution of Stroke Prevention in Nonvalvular Atrial Fibrillation Patients∗
Clinical Trials Friday, July 25th, 2014JACC: July 2014
The PREVAIL (Watchman LAA Closure Device in Patients With Atrial Fibrillation Versus Long Term Warfarin Therapy) trial is the latest in the series of studies evaluating left atrial appendage (LAA) occlusion with the Watchman device (Boston Scientific, Natick, Massachusetts) as an alternative to warfarin therapy for the prevention of stroke in patients with nonvalvular atrial fibrillation (NVAF). The PREVAIL trial was initially designed as a follow-up study to PROTECT AF (Watchman Left Atrial Appendage Closure Technology for Embolic Protection in Patients With Atrial Fibrillation), which demonstrated noninferiority to warfarin in preventing stroke 1. However, the U.S. Food and Drug Administration (FDA) raised concerns regarding acute safety events and the selection of low stroke risk patients (CHADS2 score of 1). Read More