4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation.

BACKGROUND

The PRAGUE-17 (Left Atrial Appendage Closure vs Novel Anticoagulation Agents in Atrial Fibrillation) trial demonstrated that left atrial appendage closure (LAAC) was noninferior to nonwarfarin direct oral anticoagulants (DOACs) for preventing major neurological, cardiovascular, or bleeding events in patients with atrial fibrillation (AF) who were at high risk.

OBJECTIVES

This study sought to assess the prespecified long-term (4-year) outcomes in PRAGUE-17.

METHODS

PRAGUE-17 was a randomized noninferiority trial comparing percutaneous LAAC (Watchman or Amulet) with DOACs (95% apixaban) in patients with nonvalvular AF and with a history of cardioembolism, clinically-relevant bleeding, or both CHA

RESULTS

This study randomized 402 patients with AF (201 per group, age 73.3 ± 7.0 years, 65.7% male, CHA

CONCLUSIONS

In long-term follow-up of PRAGUE-17, LAAC remains noninferior to DOACs for preventing major cardiovascular, neurological, or bleeding events. Furthermore, nonprocedural bleeding was significantly reduced with LAAC. (PRAGUE-17 [Left Atrial Appendage Closure vs Novel Anticoagulation Agents in Atrial Fibrillation]; NCT02426944).

Informations de copyright

Copyright © 2022 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

Déclaration de conflit d'intérêts

Funding Support and Author Disclosures This work was supported by a research grant AZV 15-29565A from the Ministry of Health, Czech Republic. Dr Osmancik has received occasional speaking honoraria from Bayer and Abbott. Dr Taborsky has served on Advisory Boards for Bayer and Pfizer. Dr Kala has served on an Advisory Board and Speakers Bureau for Bayer; has served on an Advisory Board for Boston Scientific; and has received consulting fees from Boston Scientific. Dr Poloczek has received speaking honoraria from Abbott. Dr Haman has received speaking honoraria from Pfizer. Dr Zemanek has received speaking honoraria from Abbott and Bayer. Dr Peichl has received occasional speaking honoraria from Abbott; and has received consulting fees from Abbott, Biotronik, and Medtronic. Dr Havranek has received speaking honoraria from Boehringer Ingelheim; and has served on an Advisory Board for Boehringer Ingelheim. Dr Widimsky has received occasional honoraria from Bayer, Pfizer, and Boehringer Ingelheim. Dr Reddy has received consulting income and grant support from Abbott Inc and Boston Scientific Inc; unrelated to this manuscript, he has also served as a consultant for Ablacon, Acutus Medical, Affera, Apama Medical, APN Health, Aquaheart, Atacor, Autonomix, Axon Therapies, Backbeat, BioSig, Biosense Webster, BioTel Heart, Biotronik, Cardiac Implants, CardiaCare, Cardiofocus, Cardionomic, CardioNXT/AFTx, Circa Scientific, CoreMap, Corvia Medical, Dinova-Hangzhou DiNovA EP Technology, East End Medical, EBR, EPD, Epix Therapeutics, EpiEP, Eximo, Farapulse, Fire1, Gore and Associates, HRT, Impulse Dynamics, Intershunt, Javelin, Kardium, Keystone Heart, LuxMed, Medlumics, Medtronic, Middlepeak, Nuvera, Philips, Pulse Biosciences, Sirona Medical, and Valcare Vizaramed; and owns equity in Ablacon, Acutus Medical, Affera, Apama Medical, APN Health, Aquaheart, Atacor, Autonomix, Axon Therapies, Backbeat, BioSig, Cardiac Implants, CardiaCare, CardioNXT/AFTx, Circa Scientific, Corvia Medical, Dinova-Hangzhou DiNovA EP Technology, East End Medical, EPD, Epix Therapeutics, EpiEP, Eximo, Farapulse, Fire1, HRT, Intershunt, Javelin, Kardium, Keystone Heart, LuxMed, Manual Surgical Sciences, Medlumics, Middlepeak, Newpace, Nuvera, Pulse Biosciences, Sirona Medical, Surecor, Valcare, and Vizaramed. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.