The aim of this study was to assess the 3-year efficacy for the endpoints of the AMULET Occluder (Abbott) left atrial appendage closure device compared with the Watchman 2.5 device.
The evaluated endpoints were analyzed according to a “per protocol” population, assessing a composite of stroke, systemic embolism, or cardiovascular death. The secondary endpoints were all-cause mortality and cardiovascular death, major bleeding, and a composite of ischemic stroke or systemic embolism.
A total of 917 Amulet Occluder implants and 916 Watchman device implants were observed. The mean age was 75 years old; 58% of patients were male, 55% of whom had paroxysmal atrial fibrillation, with a CHA2DS2-VASC of 4.6.
After a 3-year follow-up, the use of oral anticoagulants was lower with Amulet both at 18 months (3.1% vs. 5.6%; p = 0.01) and at 3 years (3.7% vs. 7.3%; p < 0.01). When analyzing the composite endpoint of stroke, systemic embolism, and cardiovascular death, there was no significant reduction (hazard ratio [HR]: 0.87; 95% confidence interval [CI]: 0.66-1.14; p = 0.31). There was evidence of a non-significant lower trend in all-cause mortality (HR: 0.81; 95% CI: 0.64-1.02; p = 0.07).
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Moreover, the study yielded similar rates for major bleeding events, defined as BARC 3 or more (HR: 1.09, 95% CI: 0.86-1.39; p = 0.46), and thromboembolic events (HR: 1.09; 95% CI: 0.70-1.70; p = 0.69).
Dr. Omar Tupayachi.
Member of the Editorial Board of SOLACI.org.
Font: 3-Year Outcomes from the AmplatzerTM AmuletTM Left Atrial Appendage Occluder Randomized Controlled Trial (Amulet IDE). Presentado por Dhanunjaya Lakkireddy en TCT Congress, Boston, EE. UU. 17 septiembre de 2022.
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