Interventional left atrial appendage closure vs novel anticoagulation agents in patients with atrial fibrillation indicated for long-term anticoagulation (PRAGUE-17 study)
Jazyk angličtina Země Spojené státy americké Médium print-electronic
Typ dokumentu srovnávací studie, časopisecké články, multicentrická studie, randomizované kontrolované studie
PubMed
27979034
DOI
10.1016/j.ahj.2016.10.003
PII: S0002-8703(16)30215-0
Knihovny.cz E-zdroje
- MeSH
- antikoagulancia terapeutické užití MeSH
- cévní mozková příhoda etiologie MeSH
- embolie etiologie MeSH
- fibrilace síní farmakoterapie chirurgie MeSH
- kardiovaskulární nemoci mortalita MeSH
- krvácení etiologie MeSH
- kvalita života MeSH
- lidé MeSH
- prospektivní studie MeSH
- síňové ouško chirurgie MeSH
- vitamin K antagonisté a inhibitory MeSH
- Check Tag
- lidé MeSH
- Publikační typ
- časopisecké články MeSH
- multicentrická studie MeSH
- randomizované kontrolované studie MeSH
- srovnávací studie MeSH
- Názvy látek
- antikoagulancia MeSH
- vitamin K MeSH
UNLABELLED: 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.
Cardiocenter Department of Cardiology Na Homolce Hospital Prague Czech Republic
Cardiocenter Department of Cardiology University Hospital Olomouc Czech Republic
Cardiocenter Institute of Clinical and Experimental Medicine Prague Czech Republic
Clinic of Cardiology Masaryk University and University Hospital Brno Brno Czech Republic
Department of Cardiology Cardiocenter Hospital Podlesí a s Trinec Czech Republic
Department of Cardiology University Hospital and Faculty of Medicine Pilsen Pilsen Czech Republic
Institute of Biostatistics and Analyses Masaryk University Brno Czech Republic
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