The Amulet left atrial appendage occluder yielded comparable rates of ischemic stroke or systemic embolism to the Watchman device at 3 years (5.0% vs 4.6%; P=0.69).
RCT (n=1,878)
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Does the Amplatzer Amulet left atrial appendage occluder reduce ischemic stroke or systemic embolism in high-risk patients compared to the Watchman 2.5 device?
At 3 years, the Amulet LAA occluder showed comparable clinical outcomes to the Watchman device with a significantly higher rate of freedom from oral anticoagulation.
Tasa de eventos absoluta: 5% vs 4.6%
valor p: p=0.69
BACKGROUND: The Amulet (Abbott) left atrial appendage occluder investigational device exemption trial is the largest randomized trial evaluating the safety and effectiveness of the Amulet left atrial appendage occluder compared with the Watchman 2.5 device (Boston Scientific) through 5 years. OBJECTIVES: This analysis evaluated the device effect on 3-year outcomes in the Amulet investigational device exemption trial. METHODS: The medication regimen and key clinical outcomes were reported through 3 years including: 1) the composite of ischemic stroke or systemic embolism (SE); 2) the composite of all strokes, SE, or cardiovascular (CV) death; 3) major bleeding; and 4) all-cause death and CV death. RESULTS: A total of 1,878 patients at 108 sites were randomized. A significantly higher percentage of patients were free of oral anticoagulation usage at 3 years with Amulet (96.2%) vs Watchman (92.5%) (P < 0.01). Clinical outcomes were comparable for the composite of ischemic stroke or SE (5.0% vs 4.6%; P = 0.69); the composite of all strokes, SE, or CV death (11.1% vs 12.7%; P = 0.31); major bleeding (16.1% vs 14.7%; P = 0.46); all-cause death (14.6% vs 17.9%; P = 0.08); and CV death (6.6% vs 8.5%; P = 0.14) for Amulet and Watchman, respectively. Through 3 years, device factors (device-related thrombus or peridevice leak ≥3 mm) preceded ischemic stroke events and CV deaths more frequently in Watchman compared with Amulet patients. CONCLUSIONS: The Amulet occluder demonstrated continued safety and effectiveness with over 96% free of oral anticoagulation usage through 3 years in a high-risk population compared to the Watchman device. (AMPLATZER Amulet LAA Occluder Trial Amulet IDE; NCT02879448).
Lakkireddy et al. (Tue,) conducted a rct in High-risk population requiring left atrial appendage occlusion (n=1,878). Amulet left atrial appendage occluder vs. Watchman 2.5 device was evaluated on Composite of ischemic stroke or systemic embolism (p=0.69). The Amulet left atrial appendage occluder yielded comparable rates of ischemic stroke or systemic embolism to the Watchman device at 3 years (5.0% vs 4.6%; P=0.69).