5-Year Results From the AMPLATZER Amulet Left Atrial Appendage Occluder Randomized Controlled Trial
- PMID: 39570242
- DOI: 10.1016/j.jacc.2024.10.101
5-Year Results From the AMPLATZER Amulet Left Atrial Appendage Occluder Randomized Controlled Trial
Abstract
Background: The Amulet IDE trial (AMPLATZER Amulet Left Atrial Appendage Occluder [LAAO] Investigational Device Exemption [IDE] Trial) evaluated the safety and effectiveness of the Amulet occluder (Abbott) in patients with nonvalvular atrial fibrillation. The Amulet IDE trial is the largest randomized LAAO trial, comparing the Amulet occluder with the Watchman 2.5 device (Boston Scientific).
Objectives: This analysis presents the 5-year results from the trial comparing the 2 devices head to head.
Methods: Patients enrolled in the Amulet IDE trial were at a high risk of stroke or systemic embolism defined as a CHADS2 score ≥2 or CHA2DS2-VASc score ≥3. Oral anticoagulation (OAC) use and key clinical outcomes are presented through 5 years.
Results: A total of 1,878 patients were randomized, with 1,833 undergoing a device implantation attempt (n = 917, Amulet occluder; and n = 916, Watchman device). A significantly higher percentage of patients were free of OAC in the Amulet occluder group at each follow-up visit, with 94.0% and 90.9% free of OAC at the last 5-year follow-up visit in the Amulet and Watchman device groups, respectively (P = 0.009). The 5-year clinical outcomes were similar between the Amulet and Watchman devices, including the composite of ischemic stroke or systemic embolism (7.4% vs 7.1%; P = 0.851), the composite of stroke, systemic embolism, or cardiovascular death (20.3% vs 20.7%; P = 0.666), major bleeding (20.1% vs 20.0%; P = 0.882), cardiovascular (CV) death (14.3% vs 15.4%; P = 0.429), and all-cause death (28.7% vs 31.1%; P = 0.217). Annualized ischemic stroke rates at 5 years were low and the same for Amulet (1.6%/y) and Watchman (1.6%/y) devices. Strokes in patients with the Amulet occluder were less severe (n = 38, nondisabling; n = 11, disabling; n = 11, fatal; n = 12, unknown) than strokes in patients with the Watchman device (n = 19, nondisabling; n = 22, disabling; n = 17, fatal; n = 10, unknown). Moreover, device factors (device-related thrombus or peridevice leak ≥3 mm) preceded stroke events and CV deaths more frequently in patients with the Watchman device (n = 63) compared with patients with the Amulet occluder (n = 31).
Conclusions: The 5-year outcomes from the largest randomized LAAO clinical trial demonstrated the long-term safety and effectiveness of the Amulet occluder and Watchman 2.5 devices. The dual-seal Amulet occluder reduces atrial fibrillation-related thromboembolic events while eliminating the need for long-term OAC. (AMPLATZER Amulet Left Atrial Appendage Occluder [LAAO] Investigational Device Exemption [IDE] Trial [Amulet IDE trial]; NCT02879448).
Keywords: Amulet; Watchman; atrial fibrillation; left atrial appendage occlusion; stroke.
Copyright © 2025 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.
Conflict of interest statement
Funding Support and Author Disclosures Abbott funded the Amulet IDE trial. No funding was provided for this analysis. Dr Lakkireddy has received institutional research and educational grants from Abbott, Atricure, Alta Thera, Medtronic, Biosense Webster, Biotronik, and Boston Scientific; and has received speaker honoraria from Abbott, Medtronic, Biotronik, and Boston Scientific. Dr Ellis has received institutional research grants from Boehringer Ingelheim, Medtronic, and Boston Scientific; and has served as a consultant or in an advisory capacity to Medtronic, Abbott Medical, Boston Scientific, and Atricure. Dr Thaler has received consulting fees from Abbott and Occlutech; and has received institutional research grants for clinical trials from Abbott and the National Institutes of Health. Dr Swarup has received consulting fees from Biosense Webster, Boston Scientific, and Abbott. Dr Gambhir has received consulting fees from Abbott, Biosense Webster, and Boston Scientific; and has received speaker honoraria from Boston Scientific. Dr Hermiller has served as a consultant to Abbott, Edwards, and Medtronic. Dr Nielsen-Kudsk has received institutional research grants from Abbott and Boston Scientific. Dr Worthley has served as a consultant and proctor to Edwards Lifesciences and Abbott; and has held shares in Three Peaks Medical. Dr Nair has received research grants and support from Medtronic, Boston Scientific, Abbott, Biosense Webster, and Adagio; has served on the advisory board of and as a consultant to Medtronic, Boston Scientific, Abbott, Biosense Webster, and Adagio; and has received honoraria from Medtronic, Boston Scientific, Abbott, Biosense Webster, and Adagio. Dr Schmidt has received speaker honoraria and consulting fees from Abbott, Boston Scientific, Biosense Webster, and Medtronic. Dr Horton has served as a consultant to Boston Scientific, Biosense Webster, St Jude/Abbott Medical, Biotronik, Baylis, and Medtronic. Dr Anderson is an employee of Abbott. Dr Gupta has received institutional research grants from Medtronic, Boston Scientific, Abbott, and CVRx. Dr Zhao is an employee of Abbott. Dr Alkhouli has served as a consultant to Boston Scientific and Abbott. Dr Windecker has received institutional research, travel, or educational grants from Abbott, Abiomed, Amgen, AstraZeneca, Bayer, B Braun, Biotronik, Boehringer Ingelheim, Boston Scientific, Bristol Myers Squibb, Cardinal Health, Cardiovalve, Cleerly, Cordis Medical, CorFlow Therapeutics, CSL Behring, Daiichi-Sankyo, Edwards Lifesciences, Farapulse, Fumedica, GE Medical Systems, Gebro Pharma, Guerbet, Idorsia, Inari Medical, InfraRedx, Janssen-Cilag, Johnson & Johnson, MedAlliance, Medicure, Medtronic, Merck Sharp & Dohme, Miracor Medical, Neucomed, Novartis, Novo Nordisk, Organon, OrPha Suisse, Pharming Technologies, Pfizer, Philips, Polares, Regeneron, Sanofi-Aventis, Servier, Siemens Healthcare, Sinomed, SMT Sahajanand Medical Technologies, Terumo, Vifor, V-Wave, and Zoll Medical; has served as an advisory board member of and/or member of the steering or executive committee group for trials funded by Abbott, Abiomed, Amgen, AstraZeneca, Bayer, Boston Scientific, Biotronik, Bristol Myers Squibb, Edwards Lifesciences, MedAlliance, Medtronic, Novartis, Polares, Recardio, Sinomed, Terumo, and V-Wave, with payments to the institution but no personal payments; and has served as a member of the steering or executive committee group for several investigator-initiated trials that receive funding by industry without impact on his personal remuneration.
Comment in
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Left atrial appendage closure after ablation: the best OPTION for patients with AF?Nat Rev Cardiol. 2025 Feb;22(2):67. doi: 10.1038/s41569-024-01113-y. Nat Rev Cardiol. 2025. PMID: 39663367 No abstract available.
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