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@article{1399046, author = {Osmancik, Pavel and Tousek, Petr and Herman, Dalibor and Neuzil, Petr and Hala, Pavel and Stasek, Josef and Haman, Ludek and Kala, Petr and Poloczek, Martin and Branny, Marian and Chovancik, Jan and Cervinka, Pavel and Holy, Jiri and Vancura, Vlastimil and Rokyta, Richard and Taborsky, Milos and Kovarnik, Tomas and Zemanek, David and Peichl, Petr and Hašková, Šárka and Jarkovský, Jiří and Widimsky, Petr}, article_location = {New York}, article_number = {JAN 2017}, doi = {http://dx.doi.org/10.1016/j.ahj.2016.10.003}, keywords = {Atrial fibrillation}, language = {eng}, issn = {0002-8703}, journal = {American Heart Journal}, title = {Interventional left atrial appendage closure vs novel anticoagulation agents in patients with atrial fibrillation indicated for long-term anticoagulation (PRAGUE-17 study)}, volume = {183}, year = {2017} }
TY - JOUR ID - 1399046 AU - Osmancik, Pavel - Tousek, Petr - Herman, Dalibor - Neuzil, Petr - Hala, Pavel - Stasek, Josef - Haman, Ludek - Kala, Petr - Poloczek, Martin - Branny, Marian - Chovancik, Jan - Cervinka, Pavel - Holy, Jiri - Vancura, Vlastimil - Rokyta, Richard - Taborsky, Milos - Kovarnik, Tomas - Zemanek, David - Peichl, Petr - Hašková, Šárka - Jarkovský, Jiří - Widimsky, Petr PY - 2017 TI - Interventional left atrial appendage closure vs novel anticoagulation agents in patients with atrial fibrillation indicated for long-term anticoagulation (PRAGUE-17 study) JF - American Heart Journal VL - 183 IS - JAN 2017 SP - 108-114 EP - 108-114 PB - Mosby Inc. SN - 00028703 KW - Atrial fibrillation N2 - 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. ER -
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). \textit{American Heart Journal}. New York: Mosby Inc., 2017, vol.~183, JAN 2017, p.~108-114. ISSN~0002-8703. Available from: https://dx.doi.org/10.1016/j.ahj.2016.10.003.
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