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Left Atrial Appendage Closure Versus Direct Oral Anticoagulants in High-Risk Patients With Atrial Fibrillation

Journal of the American College of Cardiology, 2020-06, Vol.75 (25), p.3122-3135 [Peer Reviewed Journal]

2020 American College of Cardiology Foundation ;Copyright © 2020 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved. ;ISSN: 0735-1097 ;EISSN: 1558-3597 ;DOI: 10.1016/j.jacc.2020.04.067 ;PMID: 32586585

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Title:
Left Atrial Appendage Closure Versus Direct Oral Anticoagulants in High-Risk Patients With Atrial Fibrillation
Author: Osmancik, Pavel ; Herman, Dalibor ; Neuzil, Petr ; Hala, Pavel ; Taborsky, Milos ; Kala, Petr ; Poloczek, Martin ; Stasek, Josef ; Haman, Ludek ; Branny, Marian ; Chovancik, Jan ; Cervinka, Pavel ; Holy, Jiri ; Kovarnik, Tomas ; Zemanek, David ; Havranek, Stepan ; Vancura, Vlastimil ; Opatrny, Jan ; Peichl, Petr ; Tousek, Petr ; Lekesova, Veronika ; Jarkovsky, Jiri ; Novackova, Martina ; Benesova, Klara ; Widimsky, Petr ; Reddy, Vivek Y.
Subjects: Aged ; Atrial Appendage - diagnostic imaging ; Atrial Appendage - surgery ; atrial fibrillation ; Atrial Fibrillation - complications ; Atrial Fibrillation - diagnosis ; Atrial Fibrillation - drug therapy ; Atrial Fibrillation - surgery ; Cardiac Surgical Procedures - adverse effects ; Cardiac Surgical Procedures - instrumentation ; Cardiac Surgical Procedures - methods ; cardioembolic event ; direct oral anticoagulant ; Factor Xa Inhibitors - administration & dosage ; Factor Xa Inhibitors - adverse effects ; Female ; Hemorrhage - chemically induced ; Hemorrhage - prevention & control ; Humans ; left atrial appendage ; Male ; Outcome and Process Assessment, Health Care ; Prosthesis Implantation - adverse effects ; Prosthesis Implantation - instrumentation ; Prosthesis Implantation - methods ; stroke ; Stroke - etiology ; Stroke - prevention & control
Is Part Of: Journal of the American College of Cardiology, 2020-06, Vol.75 (25), p.3122-3135
Description: 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 CHA2DS2-VASc of ≥3 and HAS-BLED of >2. Patients were randomized to receive LAAC or DOAC. The primary composite outcome was stroke, transient ischemic attack, systemic embolism, cardiovascular death, major or nonmajor clinically relevant bleeding, or procedure-/device-related complications. The primary analysis was by modified intention to treat. A high-risk patient cohort (CHA2DS2-VASc: 4.7 ± 1.5) was randomized to receive LAAC (n = 201) or DOAC (n = 201). LAAC was successful in 181 of 201 (90.0%) patients. In the DOAC group, apixaban was most frequently used (192 of 201; 95.5%). At a median 19.9 months of follow-up, the annual rates of the primary outcome were 10.99% with LAAC and 13.42% with DOAC (subdistribution hazard ratio [sHR]: 0.84; 95% confidence interval [CI]: 0.53 to 1.31; p = 0.44; p = 0.004 for noninferiority). There were no differences between groups for the components of the composite endpoint: all-stroke/TIA (sHR: 1.00; 95% CI: 0.40 to 2.51), clinically significant bleeding (sHR: 0.81; 95% CI: 0.44 to 1.52), and cardiovascular death (sHR: 0.75; 95% CI: 0.34 to 1.62). Major LAAC-related complications occurred in 9 (4.5%) patients. 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) [Display omitted]
Publisher: United States: Elsevier Inc
Language: English
Identifier: ISSN: 0735-1097
EISSN: 1558-3597
DOI: 10.1016/j.jacc.2020.04.067
PMID: 32586585
Source: Geneva Foundation Free Medical Journals at publisher websites
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Left Atrial Appendage Closure Versus Direct Oral Anticoagulants in High-Risk Patients With Atrial Fibrillation

2020 American College of Cardiology Foundation ;Copyright © 2020 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved. ;ISSN: 0735-1097 ;EISSN: 1558-3597 ;DOI: 10.1016/j.jacc.2020.04.067 ;PMID: 32586585

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