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

Lakkireddy, Dhanunjaya; Thaler, David; Ellis, Christopher R; Swarup, Vijendra; Gambhir, Alok; Hermiller, James; Nielsen-Kudsk, Jens Erik; Worthley, Stephen; Nair, Devi; Schmidt, Boris; Horton, Rodney; Gupta, Nigel; Anderson, Jordan A; Gage, Ryan; Alkhouli, Mohamad; Windecker, Stephan (2023). 3-Year Outcomes From the Amplatzer Amulet Left Atrial Appendage Occluder Randomized Controlled Trial (Amulet IDE). JACC. Cardiovascular Interventions, 16(15), pp. 1902-1913. Elsevier 10.1016/j.jcin.2023.06.022

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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).

Item Type:

Journal Article (Original Article)

Division/Institute:

04 Faculty of Medicine > Department of Cardiovascular Disorders (DHGE) > Clinic of Cardiology

UniBE Contributor:

Windecker, Stephan

Subjects:

600 Technology > 610 Medicine & health

ISSN:

1876-7605

Publisher:

Elsevier

Language:

English

Submitter:

Pubmed Import

Date Deposited:

22 Aug 2023 15:43

Last Modified:

22 Aug 2023 22:47

Publisher DOI:

10.1016/j.jcin.2023.06.022

PubMed ID:

37587599

Uncontrolled Keywords:

Watchman amulet atrial fibrillation left atrial appendage occlusion stroke

BORIS DOI:

10.48350/185536

URI:

https://boris.unibe.ch/id/eprint/185536

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