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Interventional left atrial appendage closure vs novel anticoagulation agents in patients with atrial fibrillation indicated for long-term anticoagulation (PRAGUE-17 study)

Identifikátory výsledku

  • Kód výsledku v IS VaVaI

    <a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F44555601%3A13450%2F17%3A43894521" target="_blank" >RIV/44555601:13450/17:43894521 - isvavai.cz</a>

  • Nalezeny alternativní kódy

    RIV/00216224:14110/17:00098742 RIV/00216208:11110/17:10359496 RIV/00216208:11120/17:43912579 RIV/00216208:11140/17:10359496 a 9 dalších

  • Výsledek na webu

    <a href="https://ac.els-cdn.com/S0002870316302150/1-s2.0-S0002870316302150-main.pdf?_tid=5c31c781-9385-47ef-b717-e4c134e1eae5&acdnat=1551950439_3ecf31f47d33e5b2c4f9c99e47bbd897" target="_blank" >https://ac.els-cdn.com/S0002870316302150/1-s2.0-S0002870316302150-main.pdf?_tid=5c31c781-9385-47ef-b717-e4c134e1eae5&acdnat=1551950439_3ecf31f47d33e5b2c4f9c99e47bbd897</a>

  • DOI - Digital Object Identifier

    <a href="http://dx.doi.org/10.1016/j.ahj.2016.10.003" target="_blank" >10.1016/j.ahj.2016.10.003</a>

Alternativní jazyky

  • Jazyk výsledku

    angličtina

  • Název v původním jazyce

    Interventional left atrial appendage closure vs novel anticoagulation agents in patients with atrial fibrillation indicated for long-term anticoagulation (PRAGUE-17 study)

  • Popis výsledku v původním jazyce

    Background Atrial fibrillation (AF), with a prevalence of 1% to 2%, is the most common cardiac arrhythmia. Without antithrombotic treatment, the annual risk of a cardioembolic event is 5% to 6%. The source of a cardioembolic event is a thrombus, which is usually formed in the left atrial appendage (LAA). Prevention of cardioembolic events involves treatment with anticoagulant drugs: either vitamin K antagonists or, recently, novel oral anticoagulants (NOAC). The other (nonpharmacologic) option for the prevention of a cardioembolic event involves interventional occlusion of the LAA. Objective To determine whether percutaneous LAA occlusion is noninferior to treatment with NOAC in AF patients indicated for long-term systemic anticoagulation. Study design The trial will be a prospective, multicenter, randomized noninferiority trial comparing 2 treatment strategies in moderate to high-risk AF patients (ie, patients with history of significant bleeding, or history of cardiovascular event(s), or a with CHA(2)DS(2)VASc &gt;= 3 and HAS-BLED score &gt;= 2). Patients will be randomized into a percutaneous LAA occlusion (group A) or a NOAC treatment (group B) in a 1: 1 ratio; the randomization was done using Web-based randomization software. A total of 396 study participants (198 patients in each group) will be enrolled in the study. The primary end point will be the occurrence of any of the following events within 24 months after randomization: stroke or transient ischemic attack (any type), systemic cardioembolic event, clinically significant bleeding, cardiovascular death, or a significant periprocedural or device-related complications. Conclusion The PRAGUE-17 trial will determine if LAA occlusion is noninferior to treatment with NOAC in moderate-to high-risk AF patients.

  • Název v anglickém jazyce

    Interventional left atrial appendage closure vs novel anticoagulation agents in patients with atrial fibrillation indicated for long-term anticoagulation (PRAGUE-17 study)

  • Popis výsledku anglicky

    Background Atrial fibrillation (AF), with a prevalence of 1% to 2%, is the most common cardiac arrhythmia. Without antithrombotic treatment, the annual risk of a cardioembolic event is 5% to 6%. The source of a cardioembolic event is a thrombus, which is usually formed in the left atrial appendage (LAA). Prevention of cardioembolic events involves treatment with anticoagulant drugs: either vitamin K antagonists or, recently, novel oral anticoagulants (NOAC). The other (nonpharmacologic) option for the prevention of a cardioembolic event involves interventional occlusion of the LAA. Objective To determine whether percutaneous LAA occlusion is noninferior to treatment with NOAC in AF patients indicated for long-term systemic anticoagulation. Study design The trial will be a prospective, multicenter, randomized noninferiority trial comparing 2 treatment strategies in moderate to high-risk AF patients (ie, patients with history of significant bleeding, or history of cardiovascular event(s), or a with CHA(2)DS(2)VASc &gt;= 3 and HAS-BLED score &gt;= 2). Patients will be randomized into a percutaneous LAA occlusion (group A) or a NOAC treatment (group B) in a 1: 1 ratio; the randomization was done using Web-based randomization software. A total of 396 study participants (198 patients in each group) will be enrolled in the study. The primary end point will be the occurrence of any of the following events within 24 months after randomization: stroke or transient ischemic attack (any type), systemic cardioembolic event, clinically significant bleeding, cardiovascular death, or a significant periprocedural or device-related complications. Conclusion The PRAGUE-17 trial will determine if LAA occlusion is noninferior to treatment with NOAC in moderate-to high-risk AF patients.

Klasifikace

  • Druh

    J<sub>imp</sub> - Článek v periodiku v databázi Web of Science

  • CEP obor

  • OECD FORD obor

    30201 - Cardiac and Cardiovascular systems

Návaznosti výsledku

  • Projekt

  • Návaznosti

    V - Vyzkumna aktivita podporovana z jinych verejnych zdroju

Ostatní

  • Rok uplatnění

    2017

  • Kód důvěrnosti údajů

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

Údaje specifické pro druh výsledku

  • Název periodika

    AMERICAN HEART JOURNAL

  • ISSN

    0002-8703

  • e-ISSN

  • Svazek periodika

    neuveden

  • Číslo periodika v rámci svazku

    183

  • Stát vydavatele periodika

    US - Spojené státy americké

  • Počet stran výsledku

    7

  • Strana od-do

    108-114

  • Kód UT WoS článku

    000390259600015

  • EID výsledku v databázi Scopus

    2-s2.0-85006765794