3-Year Outcomes From the Amplatzer Amulet Left Atrial Appendage Occluder Randomized Controlled Trial (Amulet IDE).

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).

Informations de copyright

Copyright © 2023 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

Déclaration de conflit d'intérêts

Funding Support and Author Disclosures Abbott funded the Amulet IDE Trial. No funding was provided for this analysis. Dr Lakkireddy has received research and educational grants to the institution from Abbott, AtriCure, Alta Thera, Medtronic, Biosense Webster, Biotronik, and Boston Scientific; and has received speaker honorarium from Abbott, Medtronic, Biotronik, and Boston Scientific. 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 Ellis has received institutional research grants from Boehringer-Ingelheim Inc, Medtronic, and Boston Scientific; and has received consulting/advisory fees from, Abbott Medical Inc, Boston Scientific, and AtriCure Inc. 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 speaker honorarium from Boston Scientific. Dr Hermiller serves as a consultant to Abbott, Edwards Lifesciences, and Medtronic. Dr Nielsen-Kudsk has received institutional research grants from Abbott and Boston Scientific. Dr Worthley has performed consultancy and proctoring for Edwards Lifesciences and Abbott; and is a shareholder for Three Peaks Medical. Dr Nair has received research grants and support from Medtronic, Boston Scientific, Abbott, Biosense Webster, and Adagio; is on the advisory board for Medtronic, Boston Scientific, Abbott, Biosense Webster, and Adagio; is a consultant for 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 honorarium and consulting fees from Abbott, Boston Scientific, Biosense Webster, and Medtronic. Dr Horton is a consultant for Boston Scientific, Biosense Webster, St. Jude/Abbott Medical, Biotronik, Baylis, and Medtronic. Dr Gupta has received institutional research grants from Medtronic, Boston Scientific, Abbott, and CVRx Inc. Dr Anderson is an employee of Abbott. Mr Gage is an employee of Abbott. Dr Alkhouli serves as a consultant to Boston Scientific and Abbott. Dr Windecker reports research, travel, or educational grants to the institution from Abbott, Abiomed, Amgen, AstraZeneca, Bayer, Biotronik, Boehringer Ingelheim, Boston Scientific, Bristol Myers Squibb, Cardinal Health, CardioValve, Corflow Therapeutics, CSL Behring, Daiichi Sankyo, Edwards Lifesciences, Guerbet, InfraRedx, Janssen-Cilag, Johnson & Johnson, Medicure, Medtronic, Merck Sharp & Dohme, Miracor Medical, Novartis, Novo Nordisk, Organon, OrPha Suisse, Pfizer, Polares, Regeneron, Sanofi, Servier, Sinomed, Terumo, Vifor, and V-Wave; serves as an advisory board member and/or member of the steering/executive group of trials funded by Abbott, Abiomed, Amgen, AstraZeneca, Bayer, Boston Scientific, Biotronik, Bristol Myers Squibb, Edwards Lifesciences, Janssen, MedAlliance, Medtronic, Novartis, Polares, Recardio, Sinomed, Terumo, V-Wave, and Xeltis with payments to the institution but no personal payments; and is a member of the steering/executive committee group of several investigator-initiated trials that receive funding by industry without impact on his personal remuneration.