Informace o publikaci

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

Autoři	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 PEICHL Petr TOUSEK Petr LEKESOVA Veronika JARKOVSKÝ Jiří NOVÁČKOVÁ Martina BENEŠOVÁ Klára WIDIMSKY Petr REDDY Vivek Y
Rok publikování	2022
Druh	Článek v odborném periodiku
Časopis / Zdroj	Journal of the American College of Cardiology
Fakulta / Pracoviště MU	Lékařská fakulta
Citace
www	https://www.jacc.org/doi/full/10.1016/j.jacc.2021.10.023
Doi	http://dx.doi.org/10.1016/j.jacc.2021.10.023
Klíčová slova	atrial fibrillation; cardioembolism; dire oral anticoagulant; left atrial appendage closure; oral anticoagulation
Popis	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(2)DS(2)-VASc >= 3 and HASBLED >= 2. The primary endpoint was a composite of cardioembolic events (stroke, transient ischemic attack, or systemic embolism), cardiovascular death, clinically relevant bleeding, or procedure-/device-related complications (LAAC group only). The primary analysis was modified intention-to-treat. RESULTS This study randomized 402 patients with AF (201 per group, age 73.3 +/- 7.0 years, 65.7% male, CHA(2)DS(2)-VASc 4.7 +/- 1.5, HASBLED 3.1 +/- 0.9). After 3.5 years median follow-up (1,354 patient-years), LAAC was noninferior to DOACs for the primary endpoint by modified intention-to-treat (subdistribution HR [sHR]: 0.81; 95% CI: 0.56-1.18; P = 0.27; P for noninferiority = 0.006). For the components of the composite endpoint, the corresponding sHRs were 0.68 (95% CI: 0.39-1.20; P = 0.19) for cardiovascular death, 1.14 (95% CI: 0.56-2.30; P = 0.72) for all-stroke/transient ischemic attack, 0.75 (95% CI: 0.44-1.27; P = 0.28) for clinically relevant bleeding, and 0.55 (95% CI: 0.31-0.97; P = 0.039) for nonprocedural clinically relevant bleeding. The primary endpoint outcomes were similar in the per-protocol (sHR: 0.80; 95% CI: 0.54-1.18; P = 0.25) and on-treatment (sHR: 0.82; 95% CI: 0.56-1.20; P = 0.30) analyses. 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. (C) 2022 by the American College of Cardiology Foundation.