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.

Basic information

Original name

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

Authors

OSMANCIK, Pavel (203 Czech Republic, guarantor), Dalibor HERMAN (203 Czech Republic), Petr NEUZIL (203 Czech Republic), Pavel HALA (203 Czech Republic), Milos TABORSKY (203 Czech Republic), Petr KALA (203 Czech Republic, belonging to the institution), Martin POLOCZEK (203 Czech Republic, belonging to the institution), Josef STASEK (203 Czech Republic), Ludek HAMAN (203 Czech Republic), Marian BRANNY (203 Czech Republic), Jan CHOVANCIK (203 Czech Republic), Pavel CERVINKA (203 Czech Republic), Jiri HOLY, Tomas KOVARNIK, David ZEMANEK (203 Czech Republic), Stepan HAVRANEK (203 Czech Republic), Vlastimil VANCURA (203 Czech Republic), Petr PEICHL (203 Czech Republic), Petr TOUSEK (203 Czech Republic), Veronika LEKESOVA (203 Czech Republic), Jiří JARKOVSKÝ (203 Czech Republic, belonging to the institution), Martina NOVÁČKOVÁ (203 Czech Republic, belonging to the institution), Klára BENEŠOVÁ (203 Czech Republic, belonging to the institution), Petr WIDIMSKY (203 Czech Republic) and Vivek Y REDDY

Edition

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

Other information

Language

English

Type of outcome

Článek v odborném periodiku

Field of Study

30201 Cardiac and Cardiovascular systems

Country of publisher

United States of America

Confidentiality degree

není předmětem státního či obchodního tajemství

References:

URL

Impact factor

Impact factor: 24.000

RIV identification code

RIV/00216224:14110/22:00126143

Organization unit

Faculty of Medicine

DOI

http://dx.doi.org/10.1016/j.jacc.2021.10.023

UT WoS

000740639300001

Keywords in English

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

Abstract

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 and 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, vol. 79, No 1, p. 1-14. ISSN 0735-1097. Available from: https://dx.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 = {http://dx.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 and 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, vol.~79, No~1, p.~1-14. ISSN~0735-1097. Available from: https://dx.doi.org/10.1016/j.jacc.2021.10.023.

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