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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)

P. Osmancik, P. Tousek, D. Herman, P. Neuzil, P. Hala, J. Stasek, L. Haman, P. Kala, M. Poloczek, M. Branny, J. Chovancik, P. Cervinka, J. Holy, V. Vancura, R. Rokyta, M. Taborsky, T. Kovarnik, D. Zemanek, P. Peichl, S. Haskova, J. Jarkovsky, P....

. 2017 ; 183 (-) : 108-114. [pub] 20161011

Language English Country United States

Document type Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial

Persistent link   https://www.medvik.cz/link/bmc17023434

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NV15-29565A MZ0 CEP Register

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NLK ProQuest Central from 2002-01-01 to 2 months ago
Nursing & Allied Health Database (ProQuest) from 2002-01-01 to 2 months ago
Health & Medicine (ProQuest) from 2002-01-01 to 2 months ago
Health Management Database (ProQuest) from 2002-01-01 to 2 months ago
Public Health Database (ProQuest) from 2002-01-01 to 2 months ago

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PubMed 27979034
DOI 10.1016/j.ahj.2016.10.003
Knihovny.cz E-resources

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 CHA2DS2VASc ≥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 24months 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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$a Atrial fibrillation (AF), with a prevalence of 1% to 2%, is the most common cardiac arrhythmia. Without antithrombotic treatment, the annual risk of a cardioembolic event is 5% to 6%. The source of a cardioembolic event is a thrombus, which is usually formed in the left atrial appendage (LAA). Prevention of cardioembolic events involves treatment with anticoagulant drugs: either vitamin K antagonists or, recently, novel oral anticoagulants (NOAC). The other (nonpharmacologic) option for the prevention of a cardioembolic event involves interventional occlusion of the LAA. OBJECTIVE: To determine whether percutaneous LAA occlusion is noninferior to treatment with NOAC in AF patients indicated for long-term systemic anticoagulation. STUDY DESIGN: The trial will be a prospective, multicenter, randomized noninferiority trial comparing 2 treatment strategies in moderate to high-risk AF patients (ie, patients with history of significant bleeding, or history of cardiovascular event(s), or a with CHA2DS2VASc ≥3 and HAS-BLED score ≥2). Patients will be randomized into a percutaneous LAA occlusion (group A) or a NOAC treatment (group B) in a 1:1 ratio; the randomization was done using Web-based randomization software. A total of 396 study participants (198 patients in each group) will be enrolled in the study. The primary end point will be the occurrence of any of the following events within 24months after randomization: stroke or transient ischemic attack (any type), systemic cardioembolic event, clinically significant bleeding, cardiovascular death, or a significant periprocedural or device-related complications. CONCLUSION: The PRAGUE-17 trial will determine if LAA occlusion is noninferior to treatment with NOAC in moderate- to high-risk AF patients.
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$a Haman, Ludek $u 1st Department of Internal Medicine, Faculty of Medicine, University Hospital Hradec Kralove, Charles University, Prague, Czech Republic.
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$a Holy, Jiri $u Department of Cardiology, Krajská zdravotni a.s., Masaryk Hospital and UJEP, Usti nad Labem, Czech Republic.
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$a Vancura, Vlastimil $u Department of Cardiology, University Hospital and Faculty of Medicine Pilsen, Pilsen, Czech Republic.
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$a Rokyta, Richard $u Department of Cardiology, University Hospital and Faculty of Medicine Pilsen, Pilsen, Czech Republic.
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$a Jarkovsky, Jiri $u Institute of Biostatistics and Analyses, Masaryk University, Brno, Czech Republic.
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$a Widimsky, Petr $u Cardiocenter, Third Faculty of Medicine, Charles University Prague and University Hospital Kralovske Vinohrady, Prague, Czech Republic.
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