Key result
Amulet occluder matches Watchman for safety and effectiveness in left atrial appendage occlusion.
Why the study?
Percutaneous LAA closure is an alternative to chronic oral anticoagulation for stroke risk reduction in nonvalvular atrial fibrillation, but the safety and effectiveness of the dual-seal Amulet occluder compared with the Watchman device required evaluation.
Does percutaneous left atrial appendage occlusion with the Amulet occluder improve safety, effectiveness, and LAA occlusion rates compared to the Watchman device in patients with nonvalvular atrial fibrillation at increased risk of stroke?
RCT (n=1,878)
Open-label
1:1 ratio, stratified by investigational site in permuted block sizes of 2, 4, and 6
Yes
Does percutaneous left atrial appendage occlusion with the Amulet occluder improve safety, effectiveness, and LAA occlusion rates compared to the Watchman device in patients with nonvalvular atrial fibrillation at increased risk of stroke?
The dual-seal Amulet occluder is noninferior to the single-seal Watchman device for safety and stroke prevention in nonvalvular atrial fibrillation, with superior LAA occlusion rates but higher initial procedure-related complications.
Answers are grounded in this paper and cite their sources.
Captured external expert commentary on this paper, strongest first. Original sources are linked where available.
“it brings solid data to a field where data are really lacking”
“The Amulet left atrial appendage occluder can safely and effectively treat more nonvalvular atrial fibrillation patients with the option to discharge without needing oral anticoagulation. Its immediate closure to reduce the risk of stroke and immediate freedom from oral anticoagulation could be attractive.”
“Are these leaks clinically relevant or not? In my mind, every leak is an issue because you're closing the appendage and you don't want a leak. But the data about the clinical importance of these leaks still needs to be investigated in a big trial, and we don't know what is the role of the leak at 45 days versus 12 months versus more than 12 months.”
Amulet provides a noninferior LAA closure option to Watchman in nonvalvular AF; extends randomized evidence for device-based stroke prevention.
Background: Percutaneous closure of the left atrial appendage (LAA) is an alternative to chronic oral anticoagulation to reduce stroke risk in patients with nonvalvular atrial fibrillation. The Amulet IDE trial (Amplatzer Amulet Left Atrial Appendage Occluder IDE Trial) was designed to evaluate the safety and effectiveness of the dual-seal mechanism of the Amulet LAA occluder compared with the Watchman device. Methods: Patients with nonvalvular atrial fibrillation at increased risk of stroke were randomly assigned (1:1) to undergo percutaneous implantation of a LAA occluder with the Amulet occluder or Watchman device. The primary end points included safety (composite of procedure-related complications, all-cause death, or major bleeding at 12 months), effectiveness (composite of ischemic stroke or systemic embolism at 18 months), and the rate of LAA occlusion at 45 days. Prespecified secondary end points included a composite of all stroke, systemic embolism, or cardiovascular/unexplained death at 18 months, major bleeding at 18 months, and superiority test of the 3 primary end points. Results: A total of 1878 patients were enrolled. The Amulet occluder was noninferior to the Watchman device for the primary safety end point (14.5% versus 14.7%; difference=–0.14 [95% CI, –3.42 to 3.13]; P <0.001 for noninferiority). Major bleeding and all-cause death were similar between groups (10.6% versus 10.0% and 3.9% versus 5.1%, respectively). Procedure-related complications were higher for the Amulet occluder (4.5% versus 2.5%), largely related to more frequent pericardial effusion and device embolization. The Amulet occluder was noninferior to the Watchman device for the primary effectiveness end point (2.8% versus 2.8%; difference=0.00 [95% CI, –1.55 to 1.55]; P <0.001 for noninferiority), and the composite of stroke, systemic embolism, or cardiovascular/unexplained death (5.6% versus 7.7%, difference=–2.12 [95% CI, –4.45 to 0.21]; P <0.001 for noninferiority). The rate of major bleeding was similar between groups (11.6% versus 12.3%; difference=–0.71 [95% CI, –3.72 to 2.31]; P =0.32 for superiority). LAA occlusion was higher for the Amulet occluder than for the Watchman device (98.9% versus 96.8%; difference=2.03 [95% CI, 0.41–3.66]; P <0.001 for noninferiority; P =0.003 for superiority). Conclusions: The Amulet occluder was noninferior for safety and effectiveness of stroke prevention for nonvalvular atrial fibrillation compared with the Watchman device and superior for LAA occlusion. Procedure-related complications were higher with the Amulet occluder and decreased with operator experience. Registration: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT02879448.
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A 2021 study conducted an RCT in Nonvalvular atrial fibrillation at increased risk of stroke (n=1,878). Amplatzer Amulet Left Atrial Appendage Occluder vs. Watchman device was evaluated on Composite of procedure-related complications, all-cause death, or major bleeding at 12 months (difference=-0.14, 95% CI -3.42 to 3.13, p=<0.001 for noninferiority). The Amulet occluder was noninferior to the Watchman device for the primary safety endpoint (14.5% vs 14.7%, p<0.001 for noninferiority) and primary effectiveness endpoint (2.8% vs 2.8%, p<0.001 for noninferiority).
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