OSMANCIK, Pavel, Petr TOUSEK, Dalibor HERMAN, Petr NEUZIL, Pavel HALA, Josef STASEK, Ludek HAMAN, Petr KALA, Martin POLOCZEK, Marian BRANNY, Jan CHOVANCIK, Pavel CERVINKA, Jiri HOLY, Vlastimil VANCURA, Richard ROKYTA, Milos TABORSKY, Tomas KOVARNIK, David ZEMANEK, Petr PEICHL, Šárka HAŠKOVÁ, Jiří JARKOVSKÝ and Petr WIDIMSKY. Interventional left atrial appendage closure vs novel anticoagulation agents in patients with atrial fibrillation indicated for long-term anticoagulation (PRAGUE-17 study). American Heart Journal. New York: Mosby Inc., vol. 183, JAN 2017, p. 108-114. ISSN 0002-8703. doi:10.1016/j.ahj.2016.10.003. 2017.
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Basic information
Original name Interventional left atrial appendage closure vs novel anticoagulation agents in patients with atrial fibrillation indicated for long-term anticoagulation (PRAGUE-17 study)
Authors OSMANCIK, Pavel (203 Czech Republic), Petr TOUSEK (203 Czech Republic), Dalibor HERMAN (203 Czech Republic), Petr NEUZIL (203 Czech Republic), Pavel HALA (203 Czech Republic), Josef STASEK (203 Czech Republic), Ludek HAMAN (203 Czech Republic), Petr KALA (203 Czech Republic, guarantor, belonging to the institution), Martin POLOCZEK (203 Czech Republic, belonging to the institution), Marian BRANNY (203 Czech Republic), Jan CHOVANCIK (203 Czech Republic), Pavel CERVINKA (203 Czech Republic), Jiri HOLY (203 Czech Republic), Vlastimil VANCURA (203 Czech Republic), Richard ROKYTA (203 Czech Republic), Milos TABORSKY (203 Czech Republic), Tomas KOVARNIK (203 Czech Republic), David ZEMANEK (203 Czech Republic), Petr PEICHL (203 Czech Republic), Šárka HAŠKOVÁ (203 Czech Republic, belonging to the institution), Jiří JARKOVSKÝ (203 Czech Republic, belonging to the institution) and Petr WIDIMSKY (203 Czech Republic).
Edition American Heart Journal, New York, Mosby Inc. 2017, 0002-8703.
Other information
Original language English
Type of outcome Article in a journal
Field of Study 30201 Cardiac and Cardiovascular systems
Country of publisher United States of America
Confidentiality degree is not subject to a state or trade secret
Impact factor Impact factor: 4.171
RIV identification code RIV/00216224:14110/17:00098742
Organization unit Faculty of Medicine
Doi http://dx.doi.org/10.1016/j.ahj.2016.10.003
UT WoS 000390259600015
Keywords in English Atrial fibrillation
Tags EL OK
Tags International impact, Reviewed
Changed by Changed by: Soňa Böhmová, učo 232884. Changed: 20/3/2018 17:52.
Abstract
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 >= 3 and HAS-BLED score >= 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.
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