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

J 2022

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

OSMANCIK, Pavel; Dalibor HERMAN; Petr NEUZIL; Pavel HALA; Milos TABORSKY et al.

Základní údaje

Originální název

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

Autoři

Vydání

Journal of the American College of Cardiology, New York, Elsevier Science INC, 2022, 0735-1097

Další údaje

Jazyk

angličtina

Typ výsledku

Článek v odborném periodiku

Obor

30201 Cardiac and Cardiovascular systems

Stát vydavatele

Spojené státy

Utajení

není předmětem státního či obchodního tajemství

Odkazy

URL

Impakt faktor

Impact factor: 24.400

Označené pro přenos do RIV

Ano

Kód RIV

RIV/00216224:14110/22:00126143

Organizační jednotka

Lékařská fakulta

Klíčová slova anglicky

atrial fibrillation; cardioembolism; dire oral anticoagulant; left atrial appendage closure; oral anticoagulation

Štítky

14110211, 14119612, rivok

Příznaky

Mezinárodní význam, Recenzováno

Změněno: 28. 6. 2022 08:57, Mgr. Tereza Miškechová

Anotace

V originále

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.

Citovat

OSMANCIK, Pavel; Dalibor HERMAN; Petr NEUZIL; Pavel HALA; Milos TABORSKY; Petr KALA; Martin POLOCZEK; Josef STASEK; Ludek HAMAN; Marian BRANNY; Jan CHOVANCIK; Pavel CERVINKA; Jiri HOLY; Tomas KOVARNIK; David ZEMANEK; Stepan HAVRANEK; Vlastimil VANCURA; Petr PEICHL; Petr TOUSEK; Veronika LEKESOVA; Jiří JARKOVSKÝ; Martina NOVÁČKOVÁ; Klára BENEŠOVÁ; Petr WIDIMSKY a Vivek Y REDDY. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. Journal of the American College of Cardiology. New York: Elsevier Science INC, 2022, roč. 79, č. 1, s. 1-14. ISSN 0735-1097. Dostupné z: https://doi.org/10.1016/j.jacc.2021.10.023.

@article{1863065,
   author = {Osmancik, Pavel and Herman, Dalibor and Neuzil, Petr and Hala, Pavel and Taborsky, Milos and Kala, Petr and Poloczek, Martin and Stasek, Josef and Haman, Ludek and Branny, Marian and Chovancik, Jan and Cervinka, Pavel and Holy, Jiri and Kovarnik, Tomas and Zemanek, David and Havranek, Stepan and Vancura, Vlastimil and Peichl, Petr and Tousek, Petr and Lekesova, Veronika and Jarkovský, Jiří and Nováčková, Martina and Benešová, Klára and Widimsky, Petr and Reddy, Vivek Y},
   article_location = {New York},
   article_number = {1},
   doi = {https://doi.org/10.1016/j.jacc.2021.10.023},
   keywords = {atrial fibrillation; cardioembolism; dire oral anticoagulant; left atrial appendage closure; oral anticoagulation},
   language = {eng},
   issn = {0735-1097},
   journal = {Journal of the American College of Cardiology},
   title = {4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation},
   url = {https://www.jacc.org/doi/full/10.1016/j.jacc.2021.10.023},
   volume = {79},
   year = {2022}
}

TY  - JOUR
ID  - 1863065
AU  - 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
PY  - 2022
TI  - 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation
JF  - Journal of the American College of Cardiology
VL  - 79
IS  - 1
SP  - 1-14
EP  - 1-14
PB  - Elsevier Science INC
SN  - 07351097
KW  - atrial fibrillation
KW  - cardioembolism
KW  - dire oral anticoagulant
KW  - left atrial appendage closure
KW  - oral anticoagulation
UR  - https://www.jacc.org/doi/full/10.1016/j.jacc.2021.10.023
N2  - 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.
ER  -

OSMANCIK, Pavel; Dalibor HERMAN; Petr NEUZIL; Pavel HALA; Milos TABORSKY; Petr KALA; Martin POLOCZEK; Josef STASEK; Ludek HAMAN; Marian BRANNY; Jan CHOVANCIK; Pavel CERVINKA; Jiri HOLY; Tomas KOVARNIK; David ZEMANEK; Stepan HAVRANEK; Vlastimil VANCURA; Petr PEICHL; Petr TOUSEK; Veronika LEKESOVA; Jiří JARKOVSKÝ; Martina NOVÁČKOVÁ; Klára BENEŠOVÁ; Petr WIDIMSKY a Vivek Y REDDY. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. \textit{Journal of the American College of Cardiology}. New York: Elsevier Science INC, 2022, roč.~79, č.~1, s.~1-14. ISSN~0735-1097. Dostupné z: https://doi.org/10.1016/j.jacc.2021.10.023.

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