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

Kód výsledku v IS VaVaI

<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00216208%3A11120%2F22%3A43922540" target="_blank" >RIV/00216208:11120/22:43922540 - isvavai.cz</a>

Nalezeny alternativní kódy

RIV/44555601:13450/22:43896813 RIV/00216224:14110/22:00126143 RIV/00216208:11110/22:10434094 RIV/00216208:11140/22:10434094 a 9 dalších

Výsledek na webu

<a href="https://doi.org/10.1016/j.jacc.2021.10.023" target="_blank" >https://doi.org/10.1016/j.jacc.2021.10.023</a>

DOI - Digital Object Identifier

<a href="http://dx.doi.org/10.1016/j.jacc.2021.10.023" target="_blank" >10.1016/j.jacc.2021.10.023</a>

Jazyk výsledku

angličtina

Název v původním jazyce

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

Popis výsledku v původním jazyce

BACKGROUND: The PRAGUE-17 trial demonstrated that left atrial appendage closure (LAAC) was non-inferior to non-warfarin oral anticoagulants (NOAC) for preventing major neurological, cardiovascular or bleeding events in high-risk patients with atrial fibrillation (AF). OBJECTIVE: To assess the pre-specified long-term (4-year) outcomes in PRAGUE-17. METHODS: PRAGUE-17 was a randomized non-inferiority trial comparing percutaneous LAAC (Watchman or Amulet) with NOACs (95% apixaban) in non-valvular AF patients with a history of cardioembolism, clinically-relevant bleeding, or both CHA(2)DS(2)-VASc &gt; 3 and HASBLED &gt; 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 (mITT). RESULTS: We randomized 402 AF patients (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 patients-years), LAAC was non-inferior to NOAC for the primary endpoint by mITT (subdistribution hazard ratio[sHR] 0.81, 95% CI 0.56-1.18; p=0.27; p for non-inferiority=0.006). For the components of the composite endpoint, the corresponding sHRs (and 95% CIs) were 0.68 (0.39-1.20; p=0.19) for cardiovascular death, 1.14 (0.56-2.30; p=0.72) for all-stroke/TIA, 0.75 (0.44-1.27; p=0.28) for clinically-relevant bleeding, and 0.55 (0.31-0.97; p=0.039) for non-procedural 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. CONCLUSION: In long-term follow-up of PRAGUE-17, LAAC remains non-inferior to NOACs for preventing major cardiovascular, neurological or bleeding events. Furthermore, non-procedural bleeding was significantly reduced with LAAC.

Název v anglickém jazyce

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

Popis výsledku anglicky

BACKGROUND: The PRAGUE-17 trial demonstrated that left atrial appendage closure (LAAC) was non-inferior to non-warfarin oral anticoagulants (NOAC) for preventing major neurological, cardiovascular or bleeding events in high-risk patients with atrial fibrillation (AF). OBJECTIVE: To assess the pre-specified long-term (4-year) outcomes in PRAGUE-17. METHODS: PRAGUE-17 was a randomized non-inferiority trial comparing percutaneous LAAC (Watchman or Amulet) with NOACs (95% apixaban) in non-valvular AF patients with a history of cardioembolism, clinically-relevant bleeding, or both CHA(2)DS(2)-VASc &gt; 3 and HASBLED &gt; 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 (mITT). RESULTS: We randomized 402 AF patients (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 patients-years), LAAC was non-inferior to NOAC for the primary endpoint by mITT (subdistribution hazard ratio[sHR] 0.81, 95% CI 0.56-1.18; p=0.27; p for non-inferiority=0.006). For the components of the composite endpoint, the corresponding sHRs (and 95% CIs) were 0.68 (0.39-1.20; p=0.19) for cardiovascular death, 1.14 (0.56-2.30; p=0.72) for all-stroke/TIA, 0.75 (0.44-1.27; p=0.28) for clinically-relevant bleeding, and 0.55 (0.31-0.97; p=0.039) for non-procedural 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. CONCLUSION: In long-term follow-up of PRAGUE-17, LAAC remains non-inferior to NOACs for preventing major cardiovascular, neurological or bleeding events. Furthermore, non-procedural bleeding was significantly reduced with LAAC.

Druh

J_imp - Článek v periodiku v databázi Web of Science

CEP obor

—

OECD FORD obor

30201 - Cardiac and Cardiovascular systems

Projekt

<a href="/cs/project/NV15-29565A" target="_blank" >NV15-29565A: Katetrizační uzávěr ouška levé síně versus terapie novými orálními antikoagulancii u rizikových pacientů s fibrilací síní (studie PRAGUE-17)</a><br>

Návaznosti

P - Projekt vyzkumu a vyvoje financovany z verejnych zdroju (s odkazem do CEP)

Rok uplatnění

2022

Kód důvěrnosti údajů

S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů

Název periodika

Journal of the American College of Cardiology

ISSN

0735-1097

e-ISSN

1558-3597

Svazek periodika

79

Číslo periodika v rámci svazku

1

Stát vydavatele periodika

US - Spojené státy americké

Počet stran výsledku

14

Strana od-do

1-14

Kód UT WoS článku

000740639300001

EID výsledku v databázi Scopus

2-s2.0-85121645291