J 2017

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

OSMANCIK, Pavel, Petr TOUSEK, Dalibor HERMAN, Petr NEUZIL, Pavel HALA et. al.

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

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

Impact factor

Impact factor: 4.171

RIV identification code

RIV/00216224:14110/17:00098742

Organization unit

Faculty of Medicine

DOI

UT WoS

000390259600015

Keywords in English

Atrial fibrillation

Tags

Tags

International impact, Reviewed
Změněno: 20/3/2018 17:52, Soňa Böhmová

Abstract

V originále

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.