PREVAIL Trial on left atrial appendage occlusion

PREVAIL Trial on left atrial appendage occlusion

The PREVAIL Trial on left atrial appendage occlusion [Prospective Randomized Evaluation of the Watchman Left Atrial Appendage Closure Device in Patients With Atrial Fibrillation Versus Long-Term Warfarin Therapy] was randomized trial which assessed the efficacy and safety of the Watchman device [1].

The previously completed PROTECT AF (Watchman Left Atrial Appendage Closure Technology for Embolic Protection in Patients With Atrial Fibrillation) trial had evaluated patients with nonvalvular atrial fibrillation and concluded that left atrial appendage occlusion was noninferior to warfarin for stroke prevention. But the study had identified a periprocedural safety hazard.

Patients in the current study were randomly assigned to either undergo left atrial appendage occlusion and subsequent discontinuation of warfarin (study group, n = 269) or receive chronic warfarin therapy (control group, n = 138).

The trial has concluded that left atrial appendage (LAA) occlusion is non inferior to warfarin for prevention of ischemic stroke or systemic embolism beyond one week post procedure. Procedural safety was shown to have improved.

Reference

1. David R Holmes Jr, Saibal Kar, Matthew J Price, Brian Whisenant, Horst Sievert, Shephal K Doshi, Kenneth Huber, Vivek Y Reddy. Prospective Randomized Evaluation of the Watchman Left Atrial Appendage Closure Device in Patients With Atrial Fibrillation Versus Long-Term Warfarin Therapy: The PREVAIL Trial. J Am Coll Cardiol. 2014 Jul 8;64(1):1-12.