title: Uninterrupted rivaroxaban vs. uninterrupted vitamin K antagonists for catheter ablation in non-valvular atrial fibrillation.
abstract: OBJECTIVE
  VENTURE-AF is the first prospective randomized trial of uninterrupted rivaroxaban and vitamin K antagonists (VKAs) in patients with non-valvular atrial fibrillation (NVAF) undergoing catheter ablation (CA).
  
  
  RESULTS
  Trial size was administratively set at 250, the protocol-specified target. Events were independently and blindly adjudicated. We randomly assigned 248 NVAF patients to uninterrupted rivaroxaban (20 mg once-daily) or to an uninterrupted VKA prior to CA and for 4 weeks afterwards. The primary endpoint was major bleeding events after CA. Secondary endpoints included thromboembolic events (composite of stroke, systemic embolism, myocardial infarction, and vascular death) and other bleeding or procedure-attributable events. Patients were 59.5 ± 10 years of age, 71% male, 74% paroxysmal AF, and had a CHA2DS2-VASc score of 1.6. The average total heparin dose used to manage activated clotting time (ACT) was slightly higher (13 871 vs. 10 964 units; P < 0.001) and the mean ACT level attained slightly lower (302 vs. 332 s; P < 0.001) in rivaroxaban and VKA arms, respectively. The incidence of major bleeding was low (0.4%; 1 major bleeding event). Similarly, thromboembolic events were low (0.8%; 1 ischemic stroke and 1 vascular death). All events occurred in the VKA arm and all after CA. The number of any adjudicated events (26 vs. 25), any bleeding events (21 vs. 18), and any other procedure-attributable events (5 vs. 5) were similar.
  
  
  CONCLUSIONS
  In patients undergoing CA for AF, the use of uninterrupted oral rivaroxaban was feasible and event rates were similar to those for uninterrupted VKA therapy.
  Clinicaltrials.gov trial registration number is NCT01729871.
authors.affiliation: Arrhythmia and Electrophysiology Center, IRCCS Humanitas Research Hospital, Rozzano, Milan, Italy Gavazzeni Hospital, Second Arrhythmia and EP Unit, Bergamo, Italy.
authors.forename: Riccardo
authors.initials: R
authors.lastname: Cappato
authors.affiliation: Section of Cardiac Electrophysiology, Hospital of the University of Pennsylvania, Philadelphia, PA, USA.
authors.forename: Francis E
authors.initials: FE
authors.lastname: Marchlinski
authors.affiliation: Department of Cardiology, Division of Clinical Electrophysiology, JW Goethe University, Frankfurt, Germany.
authors.forename: Stefan H
authors.initials: SH
authors.lastname: Hohnloser
authors.affiliation: Heart and Vascular Institute, Penn State University College of Medicine, Hershey, PA, USA.
authors.forename: Gerald V
authors.initials: GV
authors.lastname: Naccarelli
authors.affiliation: Biostatistics and Programming, Janssen Research & Development, LLC, Raritan, NJ, USA.
authors.forename: Jim
authors.initials: J
authors.lastname: Xiang
authors.affiliation: Department of Medicine, Cardiovascular Institute, Loyola University, Chicago, IL, USA.
authors.forename: David J
authors.initials: DJ
authors.lastname: Wilber
authors.affiliation: Cardiology Division, Beijing AnZhen Hospital, Capital Medical University (CMU), Beijing, China.
authors.forename: Chang-Sheng
authors.initials: CS
authors.lastname: Ma
authors.affiliation: Medical Affairs, Bayer Healthcare Pharmaceuticals, Berlin, Germany.
authors.forename: Susanne
authors.initials: S
authors.lastname: Hess
authors.affiliation: Cardiac Electrophysiology, Swedish Heart & Vascular Institute, Seattle, WA, USA.
authors.forename: Darryl S
authors.initials: DS
authors.lastname: Wells
authors.affiliation: Heart and Arrhythmia Care of New York, Manhasset, NY, USA.
authors.forename: George
authors.initials: G
authors.lastname: Juang
authors.affiliation: Division of Cardiac Electrophysiology, Jessa Hospitals, Hasselt, Belgium.
authors.forename: Johan
authors.initials: J
authors.lastname: Vijgen
authors.affiliation: Department of Cardiology and Rhythmology, Marienhaus Klinikum St. Elisabeth, Neuwied, Germany.
authors.forename: Burkhard J
authors.initials: BJ
authors.lastname: Hügl
authors.affiliation: Department of Cardiology, Royal Bournemouth Hospital, Bournemouth, United Kingdom.
authors.forename: Richard
authors.initials: R
authors.lastname: Balasubramaniam
authors.affiliation: Départment de Cardiologie, CHU de Nancy, Nancy, France.
authors.forename: Christian
authors.initials: C
authors.lastname: De Chillou
authors.affiliation: Waller Department of Cardiology, St. Mary's Hospital, Imperial College NHS Trust, London, United Kingdom.
authors.forename: D Wyn
authors.initials: DW
authors.lastname: Davies
authors.affiliation: Medical Affairs, Janssen Scientific Affairs, LLC, Raritan, NJ, USA.
authors.forename: L Eugene
authors.initials: LE
authors.lastname: Fields
authors.affiliation: Texas Cardiac Arrhythmia Institute at St. David's Medical Center, 3000 N. I-35, Suite 720, Austin, TX 78705, USA dr.natale@gmail.com.
authors.forename: Andrea
authors.initials: A
authors.lastname: Natale
mesh_terms: D000889:Anti-Arrhythmia Agents / Q000627:therapeutic use; D001281:Atrial Fibrillation / Q000601:surgery*; D016063:Blood Loss, Surgical / Q000517:prevention & control*; D017115:Catheter Ablation / Q000009:adverse effects / Q000379:methods*; D004334:Drug Administration Schedule; D065427:Factor Xa Inhibitors / Q000008:administration & dosage*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D061646:Operative Time; D011446:Prospective Studies; D011667:Pulmonary Veins / Q000601:surgery; D012008:Recurrence; D012086:Reoperation; D000069552:Rivaroxaban / Q000008:administration & dosage*; D016037:Single-Blind Method; D016896:Treatment Outcome; D014812:Vitamin K / Q000037:antagonists & inhibitors*
chemical_list: D000889:Anti-Arrhythmia Agents; D065427:Factor Xa Inhibitors; D014812:Vitamin K; D000069552:Rivaroxaban
keywords: Atrial fibrillation; Catheter ablation; Oral anticoagulant; Thromboembolism; Uninterrupted