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
