The PROTECT AF (WATCHMAN Left Atrial Appendage System for Embolic Protection in Patients With Atrial Fibrillation) trial demonstrated that left atrial appendage closure with the Watchman device was equivalent to warfarin for preventing stroke in atrial fibrillation, but it had a high rate of peri-procedural complications. The follow-up randomized trial was PREVAIL (Evaluation of the WATCHMAN LAA Closure Device in Patients With Atrial Fibrillation Versus Long Term Warfarin Therapy), in which the peri-procedural complication rate was lower (although the warfarin cohort experienced an unexpectedly low stroke rate, rendering any interpretation of the efficacy endpoints inconclusive). All of these outcomes were based on relatively few patients followed for a short time.
This work presents the final 5-year results of the PREVAIL trial, both alone and as part of a patient-level meta-analysis with the PROTECT AF trial, both with the same follow-up period.
For the PREVAIL trial, the primary endpoint was a composite of stroke, systemic embolism, or cardiovascular death, and it did not achieve non-inferiority, whereas the second primary endpoint of post-procedure stroke did achieve non-inferiority. The warfarin arm maintained an unusually low ischemic stroke rate (0.73%).
These 5-year outcomes of the PREVAIL trial, combined with the 5-year outcomes of the PROTECT AF trial, demonstrate that appendage closure with the Watchman device provides protection against stroke comparable to warfarin in patients with nonvalvular atrial fibrillation, with the advantage of additional reductions in major bleeding (particularly hemorrhagic stroke) and all-cause mortality.
Original title: 5-Year Outcomes After Left Atrial Appendage Closure. From the PREVAIL and PROTECT AF Trials.
Reference: Vivek Y. Reddy et al. J Am Coll Cardiol. 2017 Dec 19;70(24):2964-2975.
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