The Amulet IDE study randomized 1878 patients to undergo LAAO with the Amulet device or the Watchman device. Amulet was non-inferior to Watchman with respect to both a safety endpoint (procedure complications, all-cause mortality, major bleeding at 1 year; 14.5% vs. 14.7%, p<0.001) and an efficacy effectiveness endpoint (ischemic stroke or systemic embolism at 18 months; 2.8% vs. 2.8%; p<0.001). Complete LAA occlusion was higher for the Amulet device (98.9% vs. 96.8%, p=0.003 for superiority). Most Amulet patients (75.7%) were treated with 6 months of aspirin plus clopidogrel, whereas most Watchman patients (82.0%) were treated with aspirin + warfarin for 45 days prior to deescalating to aspirin + clopidogrel. Based upon these study results the US Food and Drug Administration (FDA) approved the Amulet device for implantation with 6 months of aspirin + clopidogrel.
FDA Approval Date:
August 14, 2021
Trial Publication Date:
August 30, 2021
All Editors: Andrew M. Goldsweig, MD, MSC, RPVI, FSCAI
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