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.

Autor:	Di Biase L; 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., Callans D; Hospital of the University of Pennsylvania, Philadelphia, USA., Hæusler KG; Center for Stroke Research Berlin & Department of Neurology, Charité-Universitätsmedizin Berlin, Germany., Hindricks G; Abteilung für Rhythmologie, Herzzentrum Leipzig GmbH, Leipzig, Germany., Al-Khalidi H; Department of Biostatistics & Bioinformatics, Duke University School of Medicine, USA., Mont L; Hospital Clinic Barcelona, Barcelona, Spain., Cosedis Nielsen J; Department of Clinical Medicine, Aarhus University Hospital, Denmark., Piccini JP; Duke University, Division of Cardiology Duke University Medical Center, Durham NC, USA., Schotten U; University Maastricht, Department of Physiology, Maastricht, Netherlands.; Atrial Fibrillation NETwork association (AFNET), Münster, Germany., Kirchhof P; 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.
Jazyk:	angličtina
Zdroj:	Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology [Europace] 2017 Jan; Vol. 19 (1), pp. 132-138.
DOI:	10.1093/europace/euw368
Abstrakt:	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. (Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2017. For permissions, please email: journals.permissions@oup.com.)
Databáze:	MEDLINE
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