Left Atrial Appendage Closure Versus Direct Oral Anticoagulants in High-Risk Patients With Atrial Fibrillation.
Aged
Atrial Appendage
/ diagnostic imaging
Atrial Fibrillation
/ complications
Cardiac Surgical Procedures
/ adverse effects
Factor Xa Inhibitors
/ administration & dosage
Female
Hemorrhage
/ chemically induced
Humans
Male
Outcome and Process Assessment, Health Care
Prosthesis Implantation
/ adverse effects
Stroke
/ etiology
atrial fibrillation
cardioembolic event
direct oral anticoagulant
left atrial appendage
stroke
Journal
Journal of the American College of Cardiology
ISSN: 1558-3597
Titre abrégé: J Am Coll Cardiol
Pays: United States
ID NLM: 8301365
Informations de publication
Date de publication:
30 06 2020
30 06 2020
Historique:
received:
30
01
2020
revised:
20
04
2020
accepted:
20
04
2020
entrez:
27
6
2020
pubmed:
27
6
2020
medline:
16
1
2021
Statut:
ppublish
Résumé
Percutaneous left atrial appendage closure (LAAC) is noninferior to vitamin K antagonists (VKAs) for preventing atrial fibrillation (AF)-related stroke. However, direct oral anticoagulants (DOACs) have an improved safety profile over VKAs, and their effect on cardiovascular and neurological outcomes relative to LAAC is unknown. This study sought to compare DOACs with LAAC in high-risk patients with AF. Left Atrial Appendage Closure vs. Novel Anticoagulation Agents in Atrial Fibrillation (PRAGUE-17) was a multicenter, randomized, noninferiority trial comparing LAAC with DOACs. Patients were eligible to be enrolled if they had nonvalvular AF; were indicated for oral anticoagulation (OAC); and had a history of bleeding requiring intervention or hospitalization, a history of a cardioembolic event while taking an OAC, and/or a CHA A high-risk patient cohort (CHA Among patients at high risk for stroke and increased risk of bleeding, LAAC was noninferior to DOAC in preventing major AF-related cardiovascular, neurological, and bleeding events. (Left Atrial Appendage Closure vs. Novel Anticoagulation Agents in Atrial Fibrillation [PRAGUE-17]; NCT02426944).
Sections du résumé
BACKGROUND
Percutaneous left atrial appendage closure (LAAC) is noninferior to vitamin K antagonists (VKAs) for preventing atrial fibrillation (AF)-related stroke. However, direct oral anticoagulants (DOACs) have an improved safety profile over VKAs, and their effect on cardiovascular and neurological outcomes relative to LAAC is unknown.
OBJECTIVES
This study sought to compare DOACs with LAAC in high-risk patients with AF.
METHODS
Left Atrial Appendage Closure vs. Novel Anticoagulation Agents in Atrial Fibrillation (PRAGUE-17) was a multicenter, randomized, noninferiority trial comparing LAAC with DOACs. Patients were eligible to be enrolled if they had nonvalvular AF; were indicated for oral anticoagulation (OAC); and had a history of bleeding requiring intervention or hospitalization, a history of a cardioembolic event while taking an OAC, and/or a CHA
RESULTS
A high-risk patient cohort (CHA
CONCLUSIONS
Among patients at high risk for stroke and increased risk of bleeding, LAAC was noninferior to DOAC in preventing major AF-related cardiovascular, neurological, and bleeding events. (Left Atrial Appendage Closure vs. Novel Anticoagulation Agents in Atrial Fibrillation [PRAGUE-17]; NCT02426944).
Identifiants
pubmed: 32586585
pii: S0735-1097(20)35175-5
doi: 10.1016/j.jacc.2020.04.067
pii:
doi:
Substances chimiques
Factor Xa Inhibitors
0
Banques de données
ClinicalTrials.gov
['NCT02426944']
Types de publication
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
3122-3135Commentaires et corrections
Type : CommentIn
Informations de copyright
Copyright © 2020 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.