Pavel Osmancik1, Petr Tousek2, Dalibor Herman2, Petr Neuzil3, Pavel Hala3, Josef Stasek4, Ludek Haman4, Petr Kala5, Martin Poloczek5, Marian Branny6, Jan Chovancik6, Pavel Cervinka7, Jiri Holy7, Vlastimil Vancura8, Richard Rokyta8, Milos Taborsky9, Tomas Kovarnik10, David Zemanek10, Petr Peichl11, Sarka Haskova12, Jiri Jarkovsky12, Petr Widimsky2. 1. Cardiocenter, Third Faculty of Medicine, Charles University Prague and University Hospital Kralovske Vinohrady, Prague, Czech Republic. Electronic address: pavel.osmancik@gmail.com. 2. Cardiocenter, Third Faculty of Medicine, Charles University Prague and University Hospital Kralovske Vinohrady, Prague, Czech Republic. 3. Cardiocenter, Department of Cardiology, Na Homolce Hospital, Prague, Czech Republic. 4. 1st Department of Internal Medicine, Faculty of Medicine, University Hospital Hradec Kralove, Charles University, Prague, Czech Republic. 5. Clinic of Cardiology, Masaryk University and University Hospital Brno, Brno, Czech Republic. 6. Department of Cardiology, Cardiocenter, Hospital Podlesí a.s., Trinec, Czech Republic. 7. Department of Cardiology, Krajská zdravotni a.s., Masaryk Hospital and UJEP, Usti nad Labem, Czech Republic. 8. Department of Cardiology, University Hospital and Faculty of Medicine Pilsen, Pilsen, Czech Republic. 9. Cardiocenter, Department of Cardiology, University Hospital Olomouc, Czech Republic. 10. Cardiocenter, 2nd Internal Clinic-Cardiology and Angiology, Charles University, General Faculty Hospital, Prague, Czech Republic. 11. Cardiocenter, Institute of Clinical and Experimental Medicine, Prague, Czech Republic. 12. Institute of Biostatistics and Analyses, Masaryk University, Brno, Czech Republic.
Abstract
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.
RCT Entities:
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 AFpatients 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 AFpatients (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 AFpatients.
Authors: Joseph Jensen; Christina Thaler; Retu Saxena; Domenico Calcaterra; Jason Sanchez; Quirino Orlandi; Kevin M Harris Journal: CASE (Phila) Date: 2020-02-18