title: Rationale and design of AXAFA-AFNET 5: an investigator-initiated, randomized, open, blinded outcome assessment, multi-centre trial to comparing continuous apixaban to vitamin K antagonists in patients undergoing atrial fibrillation catheter ablation.
abstract: Catheter ablation is the most efficacious rhythm control therapy in atrial fibrillation (AF) patients. There is growing evidence that catheter ablation procedures are best performed during continuous oral anticoagulation, but outcomes are variable depending on the anticoagulation strategy or agent chosen. Specifically, there is a need to evaluate the peri-procedural use of non-vitamin K antagonist oral anticoagulants (NOACs) in patients undergoing catheter ablation of AF. The AXAFA-AFNET 5 trial will test whether peri-procedural anticoagulation therapy using apixaban is a safe alternative to vitamin K antagonist (VKA) therapy for patients undergoing catheter ablation of AF.
  
  
  
  AXAFA-AFNET 5 is a randomized, prospective multi-centre study conducted in Europe and the USA. A total of 650 patients scheduled for AF ablation will be randomized 1:1 to undergo AF ablation on continuous treatment with the NOAC apixaban or with a VKA. Patients can undergo AF ablation after at least 30 days of continuous effective anticoagulation or after exclusion of atrial thrombi by transoesophageal echocardiogram. The trial includes a post-ablation magnetic resonance imaging substudy that will quantify silent brain lesions that can occur in neurologically asymptomatic patients after AF ablation. Patients will be followed on continuous anticoagulation for 3 months after the ablation. The primary outcome parameter of AXAFA-AFNET 5 is a composite of all-cause death, stroke, and major bleeding events.
  
  
  
  The results of AXAFA-AFNET 5 will provide evidence informing about the safety of apixaban in ablation patients and on its efficacy including effects on silent brain lesions. AXAFA - AFNET 5 is an investigator-initiated trial sponsored by AFNET. The trial is supported by the DZHK (German Centre for Cardiovascular Research) and by the BMBF (German Ministry of Education and Research) and by Bristol-Myers Squibb/Pfizer Alliance.
authors.affiliation: Albert Einstein College of Medicine, Montefiore Hospital, NY, USA.|Texas Cardiac Arrhythmia Institute at St. David's Medical Center, Austin, TX, USA.|Department of Biomedical Engineering, University of Texas, Austin, TX, USA.|Department of Cardiology, University of Foggia, Foggia, Italy.
authors.forename: Luigi
authors.initials: L
authors.lastname: Di Biase
authors.affiliation: Hospital of the University of Pennsylvania, Philadelphia, USA.
authors.forename: David
authors.initials: D
authors.lastname: Callans
authors.affiliation: Center for Stroke Research Berlin & Department of Neurology, Charité-Universitätsmedizin Berlin, Germany.
authors.forename: Karl Georg
authors.initials: KG
authors.lastname: Hæusler
authors.affiliation: Abteilung für Rhythmologie, Herzzentrum Leipzig GmbH, Leipzig, Germany.
authors.forename: Gerhard
authors.initials: G
authors.lastname: Hindricks
authors.affiliation: Department of Biostatistics & Bioinformatics, Duke University School of Medicine, USA.
authors.forename: Hussein
authors.initials: H
authors.lastname: Al-Khalidi
authors.affiliation: Hospital Clinic Barcelona, Barcelona, Spain.
authors.forename: Lluis
authors.initials: L
authors.lastname: Mont
authors.affiliation: Department of Clinical Medicine, Aarhus University Hospital, Denmark.
authors.forename: Jens
authors.initials: J
authors.lastname: Cosedis Nielsen
authors.affiliation: Duke University, Division of Cardiology Duke University Medical Center, Durham NC, USA.
authors.forename: Jonathan P
authors.initials: JP
authors.lastname: Piccini
authors.affiliation: University Maastricht, Department of Physiology, Maastricht, Netherlands.|Atrial Fibrillation NETwork association (AFNET), Münster, Germany.
authors.forename: Ulrich
authors.initials: U
authors.lastname: Schotten
authors.affiliation: Atrial Fibrillation NETwork association (AFNET), Münster, Germany p.kirchhof@bham.ac.uk.|University of Birmingham Institute of Cardiovascular Sciences, SWBH and UHB NHS Trusts, Birmingham, UK.|Department of Cardiovascular Medicine, Hospital of the University of Münster, Münster, Germany.
authors.forename: Paulus
authors.initials: P
authors.lastname: Kirchhof
mesh_terms: D000284:Administration, Oral; D000925:Anticoagulants / Q000008:administration & dosage* / Q000009:adverse effects; D001281:Atrial Fibrillation / Q000175:diagnosis / Q000401:mortality / Q000503:physiopathology / Q000601:surgery*; D017115:Catheter Ablation / Q000009:adverse effects / Q000401:mortality; D004334:Drug Administration Schedule; D017548:Echocardiography, Transesophageal; D005060:Europe; D065427:Factor Xa Inhibitors / Q000008:administration & dosage* / Q000009:adverse effects; D006470:Hemorrhage / Q000139:chemically induced; D006801:Humans; D008279:Magnetic Resonance Imaging; D011446:Prospective Studies; D011720:Pyrazoles / Q000008:administration & dosage* / Q000009:adverse effects; D011728:Pyridones / Q000008:administration & dosage* / Q000009:adverse effects; D012107:Research Design; D012307:Risk Factors; D020521:Stroke / Q000000981:diagnostic imaging / Q000401:mortality / Q000517:prevention & control*; D013997:Time Factors; D016896:Treatment Outcome; D014481:United States; D014812:Vitamin K / Q000037:antagonists & inhibitors*
chemical_list: D000925:Anticoagulants; D065427:Factor Xa Inhibitors; D011720:Pyrazoles; D011728:Pyridones; D014812:Vitamin K; C522181:apixaban
keywords: Ablation; Apixaban; Atrial fibrillation; Bleeding; Oral anticoagulation; Stroke ; Un-interrupted; Warfarin