title: Interventional left atrial appendage closure vs novel anticoagulation agents in patients with atrial fibrillation indicated for long-term anticoagulation (PRAGUE-17 study).
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.
  
  
  METHODS
  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.
  
  
  CONCLUSIONS
  The PRAGUE-17 trial will determine if LAA occlusion is noninferior to treatment with NOAC in moderate- to high-risk AF patients.
authors.affiliation: Cardiocenter, Third Faculty of Medicine, Charles University Prague and University Hospital Kralovske Vinohrady, Prague, Czech Republic. Electronic address: pavel.osmancik@gmail.com.
authors.forename: Pavel
authors.initials: P
authors.lastname: Osmancik
authors.affiliation: Cardiocenter, Third Faculty of Medicine, Charles University Prague and University Hospital Kralovske Vinohrady, Prague, Czech Republic.
authors.forename: Petr
authors.initials: P
authors.lastname: Tousek
authors.affiliation: Cardiocenter, Third Faculty of Medicine, Charles University Prague and University Hospital Kralovske Vinohrady, Prague, Czech Republic.
authors.forename: Dalibor
authors.initials: D
authors.lastname: Herman
authors.affiliation: Cardiocenter, Department of Cardiology, Na Homolce Hospital, Prague, Czech Republic.
authors.forename: Petr
authors.initials: P
authors.lastname: Neuzil
authors.affiliation: Cardiocenter, Department of Cardiology, Na Homolce Hospital, Prague, Czech Republic.
authors.forename: Pavel
authors.initials: P
authors.lastname: Hala
authors.affiliation: 1st Department of Internal Medicine, Faculty of Medicine, University Hospital Hradec Kralove, Charles University, Prague, Czech Republic.
authors.forename: Josef
authors.initials: J
authors.lastname: Stasek
authors.affiliation: 1st Department of Internal Medicine, Faculty of Medicine, University Hospital Hradec Kralove, Charles University, Prague, Czech Republic.
authors.forename: Ludek
authors.initials: L
authors.lastname: Haman
authors.affiliation: Clinic of Cardiology, Masaryk University and University Hospital Brno, Brno, Czech Republic.
authors.forename: Petr
authors.initials: P
authors.lastname: Kala
authors.affiliation: Clinic of Cardiology, Masaryk University and University Hospital Brno, Brno, Czech Republic.
authors.forename: Martin
authors.initials: M
authors.lastname: Poloczek
authors.affiliation: Department of Cardiology, Cardiocenter, Hospital Podlesí a.s., Trinec, Czech Republic.
authors.forename: Marian
authors.initials: M
authors.lastname: Branny
authors.affiliation: Department of Cardiology, Cardiocenter, Hospital Podlesí a.s., Trinec, Czech Republic.
authors.forename: Jan
authors.initials: J
authors.lastname: Chovancik
authors.affiliation: Department of Cardiology, Krajská zdravotni a.s., Masaryk Hospital and UJEP, Usti nad Labem, Czech Republic.
authors.forename: Pavel
authors.initials: P
authors.lastname: Cervinka
authors.affiliation: Department of Cardiology, Krajská zdravotni a.s., Masaryk Hospital and UJEP, Usti nad Labem, Czech Republic.
authors.forename: Jiri
authors.initials: J
authors.lastname: Holy
authors.affiliation: Department of Cardiology, University Hospital and Faculty of Medicine Pilsen, Pilsen, Czech Republic.
authors.forename: Vlastimil
authors.initials: V
authors.lastname: Vancura
authors.affiliation: Department of Cardiology, University Hospital and Faculty of Medicine Pilsen, Pilsen, Czech Republic.
authors.forename: Richard
authors.initials: R
authors.lastname: Rokyta
authors.affiliation: Cardiocenter, Department of Cardiology, University Hospital Olomouc, Czech Republic.
authors.forename: Milos
authors.initials: M
authors.lastname: Taborsky
authors.affiliation: Cardiocenter, 2nd Internal Clinic-Cardiology and Angiology, Charles University, General Faculty Hospital, Prague, Czech Republic.
authors.forename: Tomas
authors.initials: T
authors.lastname: Kovarnik
authors.affiliation: Cardiocenter, 2nd Internal Clinic-Cardiology and Angiology, Charles University, General Faculty Hospital, Prague, Czech Republic.
authors.forename: David
authors.initials: D
authors.lastname: Zemanek
authors.affiliation: Cardiocenter, Institute of Clinical and Experimental Medicine, Prague, Czech Republic.
authors.forename: Petr
authors.initials: P
authors.lastname: Peichl
authors.affiliation: Institute of Biostatistics and Analyses, Masaryk University, Brno, Czech Republic.
authors.forename: Sarka
authors.initials: S
authors.lastname: Haskova
authors.affiliation: Institute of Biostatistics and Analyses, Masaryk University, Brno, Czech Republic.
authors.forename: Jiri
authors.initials: J
authors.lastname: Jarkovsky
authors.affiliation: Cardiocenter, Third Faculty of Medicine, Charles University Prague and University Hospital Kralovske Vinohrady, Prague, Czech Republic.
authors.forename: Petr
authors.initials: P
authors.lastname: Widimsky
mesh_terms: D000925:Anticoagulants / Q000627:therapeutic use*; D020517:Atrial Appendage / Q000601:surgery*; D001281:Atrial Fibrillation / Q000188:drug therapy* / Q000601:surgery*; D002318:Cardiovascular Diseases / Q000401:mortality; D004617:Embolism / Q000209:etiology; D006470:Hemorrhage / Q000209:etiology; D006801:Humans; D011446:Prospective Studies; D011788:Quality of Life; D020521:Stroke / Q000209:etiology; D014812:Vitamin K / Q000037:antagonists & inhibitors
chemical_list: D000925:Anticoagulants; D014812:Vitamin K