Nonprocedural bleeding after left atrial appendage closure
versus direct oral anticoagulants: A subanalysis of the
randomized PRAGUE-17 trial

J 2023

Nonprocedural bleeding after left atrial appendage closure versus direct oral anticoagulants: A subanalysis of the randomized PRAGUE-17 trial

BRANNY, Marian, Pavel OSMANCIK, Petr KALA, Martin POLOCZEK, Dalibor HERMAN et. al.

Basic information

Original name

Nonprocedural bleeding after left atrial appendage closure versus direct oral anticoagulants: A subanalysis of the randomized PRAGUE-17 trial

Authors

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

Edition

Journal of Cardiovascular Electrophysiology, HOBOKEN, Wiley-Blackwell, 2023, 1045-3873

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: 2.700 in 2022

RIV identification code

RIV/00216224:14110/23:00132260

Organization unit

Faculty of Medicine

DOI

http://dx.doi.org/10.1111/jce.16029

UT WoS

001040991200001

Keywords in English

atrial fibrillation; bleeding; gastrointestinal bleeding; left atrial appendage closure; major bleeding; nonvitamin K anticoagulants

Abstract

V originále

IntroductionObservational studies have shown low bleeding rates in patients with atrial fibrillation (AF) treated by left atrial appendage closure (LAAC); however, data from randomized studies are lacking. This study compared bleeding events among patients with AF treated by LAAC and nonvitamin K anticoagulants (NOAC). MethodsThe Prague-17 trial was a prospective, multicenter, randomized trial that compared LAAC to NOAC in high-risk AF patients. The primary endpoint was a composite of a cardioembolic event, cardiovascular death, and major and clinically relevant nonmajor bleeding (CRNMB) defined according to the International Society on Thrombosis and Hemostasis (ISTH). ResultsThe trial enrolled 402 patients (201 per arm), and the median follow-up was 3.5 (IQR 2.6-4.2) years. Bleeding occurred in 24 patients (29 events) and 32 patients (40 events) in the LAAC and NOAC groups, respectively. Six of the LAAC bleeding events were procedure/device-related. In the primary intention-to-treat analysis, LAAC was associated with similar rates of ISTH major or CRNMB (sHR 0.75, 95% CI 0.44-1.27, p = 0.28), but with a reduction in nonprocedural major or CRNMB (sHR 0.55, 95% CI 0.31-0.97, p = 0.039). This reduction for nonprocedural bleeding with LAAC was mainly driven by a reduced rate of CRNMB (sHR for major bleeding 0.69, 95% CI 0.34-1.39, p = .30; sHR for CRNMB 0.43, 95% CI 0.18-1.03, p = 0.059). History of bleeding was a predictor of bleeding during follow-up. Gastrointestinal bleeding was the most common bleeding site in both groups. ConclusionDuring the 4-year follow-up, LAAC was associated with less nonprocedural bleeding. The reduction is mainly driven by a decrease in CRNMB.

Citovat

BRANNY, Marian, Pavel OSMANCIK, Petr KALA, Martin POLOCZEK, Dalibor HERMAN, Petr NEUZIL, Pavel HALA, Milos TABORSKY, Josef STASEK, Ludek HAMAN, Jan CHOVANCIK, Pavel CERVINKA, Jiri HOLY, Tomas KOVARNIK, David ZEMANEK, Stepan HAVRANEK, Vlastimil VANCURA, Petr PEICHL, Petr TOUSEK, Marek HOZMAN, Veronika LEKESOVA, Jiří JARKOVSKÝ, Martina NOVÁČKOVÁ, Klára BENEŠOVÁ, Petr Y WIDIMSKY and Vivek REDDY. Nonprocedural bleeding after left atrial appendage closure versus direct oral anticoagulants: A subanalysis of the randomized PRAGUE-17 trial. Journal of Cardiovascular Electrophysiology. HOBOKEN: Wiley-Blackwell, 2023, vol. 34, No 9, p. 1885-1895. ISSN 1045-3873. Available from: https://dx.doi.org/10.1111/jce.16029.

@article{2339538,
   author = {Branny, Marian and Osmancik, Pavel and Kala, Petr and Poloczek, Martin and Herman, Dalibor and Neuzil, Petr and Hala, Pavel and Taborsky, Milos and Stasek, Josef and Haman, Ludek 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 Hozman, Marek and Lekesova, Veronika and Jarkovský, Jiří and Nováčková, Martina and Benešová, Klára and Widimsky, Petr Y and Reddy, Vivek},
   article_location = {HOBOKEN},
   article_number = {9},
   doi = {http://dx.doi.org/10.1111/jce.16029},
   keywords = {atrial fibrillation; bleeding; gastrointestinal bleeding; left atrial appendage closure; major bleeding; nonvitamin K anticoagulants},
   language = {eng},
   issn = {1045-3873},
   journal = {Journal of Cardiovascular Electrophysiology},
   title = {Nonprocedural bleeding after left atrial appendage closure versus direct oral anticoagulants: A subanalysis of the randomized PRAGUE-17 trial},
   url = {https://onlinelibrary.wiley.com/doi/10.1111/jce.16029},
   volume = {34},
   year = {2023}
}

TY  - JOUR
ID  - 2339538
AU  - Branny, Marian - Osmancik, Pavel - Kala, Petr - Poloczek, Martin - Herman, Dalibor - Neuzil, Petr - Hala, Pavel - Taborsky, Milos - Stasek, Josef - Haman, Ludek - Chovancik, Jan - Cervinka, Pavel - Holy, Jiri - Kovarnik, Tomas - Zemanek, David - Havranek, Stepan - Vancura, Vlastimil - Peichl, Petr - Tousek, Petr - Hozman, Marek - Lekesova, Veronika - Jarkovský, Jiří - Nováčková, Martina - Benešová, Klára - Widimsky, Petr Y - Reddy, Vivek
PY  - 2023
TI  - Nonprocedural bleeding after left atrial appendage closure versus direct oral anticoagulants: A subanalysis of the randomized PRAGUE-17 trial
JF  - Journal of Cardiovascular Electrophysiology
VL  - 34
IS  - 9
SP  - 1885-1895
EP  - 1885-1895
PB  - Wiley-Blackwell
SN  - 10453873
KW  - atrial fibrillation
KW  - bleeding
KW  - gastrointestinal bleeding
KW  - left atrial appendage closure
KW  - major bleeding
KW  - nonvitamin K anticoagulants
UR  - https://onlinelibrary.wiley.com/doi/10.1111/jce.16029
N2  - IntroductionObservational studies have shown low bleeding rates in patients with atrial fibrillation (AF) treated by left atrial appendage closure (LAAC); however, data from randomized studies are lacking. This study compared bleeding events among patients with AF treated by LAAC and nonvitamin K anticoagulants (NOAC). MethodsThe Prague-17 trial was a prospective, multicenter, randomized trial that compared LAAC to NOAC in high-risk AF patients. The primary endpoint was a composite of a cardioembolic event, cardiovascular death, and major and clinically relevant nonmajor bleeding (CRNMB) defined according to the International Society on Thrombosis and Hemostasis (ISTH). ResultsThe trial enrolled 402 patients (201 per arm), and the median follow-up was 3.5 (IQR 2.6-4.2) years. Bleeding occurred in 24 patients (29 events) and 32 patients (40 events) in the LAAC and NOAC groups, respectively. Six of the LAAC bleeding events were procedure/device-related. In the primary intention-to-treat analysis, LAAC was associated with similar rates of ISTH major or CRNMB (sHR 0.75, 95% CI 0.44-1.27, p = 0.28), but with a reduction in nonprocedural major or CRNMB (sHR 0.55, 95% CI 0.31-0.97, p = 0.039). This reduction for nonprocedural bleeding with LAAC was mainly driven by a reduced rate of CRNMB (sHR for major bleeding 0.69, 95% CI 0.34-1.39, p = .30; sHR for CRNMB 0.43, 95% CI 0.18-1.03, p = 0.059). History of bleeding was a predictor of bleeding during follow-up. Gastrointestinal bleeding was the most common bleeding site in both groups. ConclusionDuring the 4-year follow-up, LAAC was associated with less nonprocedural bleeding. The reduction is mainly driven by a decrease in CRNMB.
ER  -

BRANNY, Marian, Pavel OSMANCIK, Petr KALA, Martin POLOCZEK, Dalibor HERMAN, Petr NEUZIL, Pavel HALA, Milos TABORSKY, Josef STASEK, Ludek HAMAN, Jan CHOVANCIK, Pavel CERVINKA, Jiri HOLY, Tomas KOVARNIK, David ZEMANEK, Stepan HAVRANEK, Vlastimil VANCURA, Petr PEICHL, Petr TOUSEK, Marek HOZMAN, Veronika LEKESOVA, Jiří JARKOVSKÝ, Martina NOVÁČKOVÁ, Klára BENEŠOVÁ, Petr Y WIDIMSKY and Vivek REDDY. Nonprocedural bleeding after left atrial appendage closure versus direct oral anticoagulants: A subanalysis of the randomized PRAGUE-17 trial. \textit{Journal of Cardiovascular Electrophysiology}. HOBOKEN: Wiley-Blackwell, 2023, vol.~34, No~9, p.~1885-1895. ISSN~1045-3873. Available from: https://dx.doi.org/10.1111/jce.16029.

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