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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.

Publication ,  Journal Article
Di Biase, L; Callans, D; Hæusler, KG; Hindricks, G; Al-Khalidi, H; Mont, L; Cosedis Nielsen, J; Piccini, JP; Schotten, U; Kirchhof, P
Published in: Europace
January 2017

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.

Duke Scholars

Published In

Europace

DOI

EISSN

1532-2092

Publication Date

January 2017

Volume

19

Issue

1

Start / End Page

132 / 138

Location

England

Related Subject Headings

  • Vitamin K
  • United States
  • Treatment Outcome
  • Time Factors
  • Stroke
  • Risk Factors
  • Research Design
  • Pyridones
  • Pyrazoles
  • Prospective Studies
 

Citation

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Di Biase, L., Callans, D., Hæusler, K. G., Hindricks, G., Al-Khalidi, H., Mont, L., … Kirchhof, P. (2017). 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. Europace, 19(1), 132–138. https://doi.org/10.1093/europace/euw368
Di Biase, Luigi, David Callans, Karl Georg Hæusler, Gerhard Hindricks, Hussein Al-Khalidi, Lluis Mont, Jens Cosedis Nielsen, Jonathan P. Piccini, Ulrich Schotten, and Paulus Kirchhof. “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.Europace 19, no. 1 (January 2017): 132–38. https://doi.org/10.1093/europace/euw368.
Journal cover image

Published In

Europace

DOI

EISSN

1532-2092

Publication Date

January 2017

Volume

19

Issue

1

Start / End Page

132 / 138

Location

England

Related Subject Headings

  • Vitamin K
  • United States
  • Treatment Outcome
  • Time Factors
  • Stroke
  • Risk Factors
  • Research Design
  • Pyridones
  • Pyrazoles
  • Prospective Studies