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

Luigi Di Biase, David Callans, Karl Georg Haeusler, Gerhard Hindricks, Hussein Al-Khalidi, Lluis Mont, Jens Cosedis Nielsen, Jonathan P. Piccini, Ulrich Schotten, Paulus Kirchhof*

*Corresponding author for this work

Research output: Contribution to journalArticleAcademicpeer-review

Abstract

Aims 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.

Methods and results 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.

Conclusion 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.

Original languageEnglish
Pages (from-to)132-138
Number of pages7
JournalEP Europace
Volume19
Issue number1
DOIs
Publication statusPublished - Jan 2017

Keywords

  • Atrial fibrillation
  • Ablation
  • Oral anticoagulation
  • Apixaban
  • Warfarin
  • Un-interrupted
  • Stroke
  • Bleeding
  • ACADEMIC RESEARCH CONSORTIUM
  • PERIPROCEDURAL ANTICOAGULATION
  • RADIOFREQUENCY ABLATION
  • BLEEDING COMPLICATIONS
  • UNINTERRUPTED RIVAROXABAN
  • MEDICARE BENEFICIARIES
  • ORAL ANTICOAGULANTS
  • SAFETY
  • DABIGATRAN
  • MANAGEMENT

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