Journal article
Interventional left atrial appendage closure vs novel anticoagulation agents in patients with atrial fibrillation indicated for long-term anticoagulation (PRAGUE-17 study)
The American heart journal, Vol.183, pp.108-114
01/01/2017
DOI: 10.1016/j.ahj.2016.10.003
PMID: 27979034
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.
Details
- Title: Subtitle
- Interventional left atrial appendage closure vs novel anticoagulation agents in patients with atrial fibrillation indicated for long-term anticoagulation (PRAGUE-17 study)
- Creators
- Pavel Osmancik - University Hospital Kralovske VinohradyPetr Tousek - Charles UniversityDalibor Herman - University Hospital Kralovske VinohradyPetr Neuzil - Na Homolce HospitalPavel Hala - Na Homolce HospitalJosef Stasek - Charles UniversityLudek Haman - Charles UniversityPetr Kala - Masaryk UniversityMartin Poloczek - Masaryk UniversityMarian Branny - Nemocnice PodlesíJan Chovancik - Nemocnice PodlesíPavel Cervinka - Krajská ZdravotníJiri Holy - Krajská ZdravotníVlastimil Vancura - Univ Hosp, Dept Cardiol, Plzen, Czech RepublicRichard Rokyta - Univ Hosp, Dept Cardiol, Plzen, Czech RepublicMilos Taborsky - University Hospital OlomoucTomas Kovarnik - Charles UniversityDavid Zemanek - Charles UniversityPetr Peichl - Institute of Clinical and Experimental MedicineSarka Haskova - Masaryk UniversityJiri Jarkovsky - Krajská ZdravotníPetr Widimsky - Institute of Clinical and Experimental MedicinePRAGUE-17 Investigators
- Resource Type
- Journal article
- Publication Details
- The American heart journal, Vol.183, pp.108-114
- Publisher
- Elsevier
- DOI
- 10.1016/j.ahj.2016.10.003
- PMID
- 27979034
- ISSN
- 0002-8703
- eISSN
- 1097-6744
- Number of pages
- 7
- Grant note
- AZV 15-29565A / Ministry of Health Czech Republic; Ministry of Health, Czech Republic; Czech Republic Government
- Language
- English
- Date published
- 01/01/2017
- Academic Unit
- Electrical and Computer Engineering
- Record Identifier
- 9984627291102771
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