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A device to occlude the left atrial appendage (LAA) as an effective alternative to oral anticoagulation in patients with nonvalvular atrial fibrillation (NVAF) has been elusive. Early procedural complications limited the benefit of the Watchman device in the PROTECT-AF trial (NEJM JW General Medicine Aug 27 2009), prompting this second manufacturer-sponsored, multicenter study, the PREVAIL trial (NCT01182441).
The study population included 407 patients with NVAF, CHADS2 score >2 (or score of 1 with other high-risk characteristics) who were randomized 2:1 to Watchman versus warfarin. Warfarin discontinuation, permitted by successful implantation and documented LAA occlusion, occurred in 92%, 98%, and 99% of Watchman patients at 45 days, 6 mon…