Amulet IDE Trial: Amulet LAA closure device vs. Watchman for Stroke ppx

amulet ide trial watchman
2021 AMULET IDE TRIAL Amplatzer Amulet left atrial appendage occluder versus watchman device for stroke prophylaxis multicenter, open label, prospective, randomized controlled trial M Objective: To evaluate the safety & effectiveness of the dual-seal mechanism of the Amulet left atrial appendage occluder compared with the Watchman device among patients with nonvalvular atrial fibrillation (AF) 1878 patients Inclusion criteria: Patients > 18 years with paroxysmal, persistent, or permanent nonvalvular AF at increased risk of stroke or systemic embolism with CHA2DS2-VASc score of ≥ 3 suitable for short-term oral anticoagulation (OAC), but not for long-term OAC Dual-seal mechanism LAA occluder: 2.8 14.5 Amulet device (n = 934) VS Single-seal mechanism LAA occluder: Watchman device (n = 944) PRIMARY OUTCOMES Composite of ischemic stroke or systemic embolism at 18M % Diff 0.00; 95% CI, -1.55 to 1.55; P<0.001 for noninferiority Composite of all-cause death, procedure-related complications, or major bleeding at 12M % Diff -0.14; 95% CI, -3.42 to 3.13; P<0.001 for noninferiority SECONDARY OUTCOMES 2.8 14.7 Composite of cardiovascular mortality, 5.6 ischemic stroke, or systemic embolism % 7.7 P<0.0001 for noninferiority LAA occlusion % 98.9 Diff 2.03; 95% CI, 0.41 to -3.66; 96.8 P<0.001 for noninferiority P=0.003 for superiority Conclusion: The Amulet occluder was noninferior for safety and effectiveness of stroke prevention for nonvalvular atrial fibrillation compared with the Watchman device & superior for LAA occlusion. Procedure-related complications were higher with the Amulet occluder and decreased with operator experience. D Lakkireddy et al. Circulation. 2021;144:1543-1552


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