Interventional left atrial appendage closure vs novel anticoagulation agents in patients with atrial fibrillation indicated for long-term anticoagulation (PRAGUE-17 study) - 18/04/17
, Petr Tousek, MD, PhD a, Dalibor Herman, MD, PhD a, Petr Neuzil, MD, CSc b, Pavel Hala, MD b, Josef Stasek, MD, PhD c, Ludek Haman, MD, PhD c, Petr Kala, MD, PhD d, Martin Poloczek, MD d, Marian Branny, MD, PhD e, Jan Chovancik, MD e, Pavel Cervinka, MD, PhD f, Jiri Holy, MD f, Vlastimil Vancura, MD, PhD g, Richard Rokyta, MD, PhD g, Milos Taborsky, MD, CSc h, Tomas Kovarnik, MD, PhD i, David Zemanek, MD, PhD i, Petr Peichl, MD, PhD j, Sarka Haskova, Eng k, Jiri Jarkovsky, Eng k, Petr Widimsky, MD, DrSc aon behalf of the
PRAGUE-17 Investigators
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 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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| RCT No: NCT02426944. |
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| Financial support: Research grant from the Ministry of Health Czech Republic (AZV 15-29565A). |
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| Conflicts of interests: None. |
Vol 183
P. 108-114 - gennaio 2017 Ritorno al numero
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