Holmes DR Jr, et al. "Prospective randomized evaluation of the Watchman Left Atrial Appendage Closure device in patients with atrial fibrillation versus long-term warfarin therapy: the PREVAIL trial". JACC. 2014. 64(1):1-12.
In patients with nonvalvular atrial fibrillation, how does the safety and efficacy of the Watchman LAA Closure Technology compare with long-term warfarin therapy for stroke prevention?
LAA occlusion was noninferior to warfarin for ischemic stroke prevention or systemic embolism (SE) >7 days post-procedure.
The PROTECT AF trial showed that the Watchman LAA Closure Technology was noninferior to warfarin for stroke prevention in patients with NVAF, but a periprocedural safety hazard was identified. The PREVAIL study was designed to provide additional information on the safety and efficacy of the LAA closure technology. PREVAIL provided additional data that LAA occlusion is a reasonable alternative to warfarin therapy for stroke prevention in patients with NVAF. It should be noted that noninferiority was not achieved for overall efficacy, however procedural safety had significantly improved.
Comparison of ischemic stroke and systemic embolism occurring greater than 7 days post randomization.
TEE was performed at 45 days, 6 months, and 12 months follow-up.
This study was sponsored by Atritech/Boston Scientific Corporation.
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