Atrial fibrillation (AF) is the most frequent arrhythmia – affecting several millions of people in Europe and US. AF is associated with a high risk of stroke and other severe complications. Most of the patients need anticoagulation therapy to reduce their risk of stroke.
5-15% of the patients suffering from AF undergo catheter ablation treatment. During and after the ablation procedure, they require anticoagulation to reduce the risk of procedure-associated stroke. Factor Xa inhibitors and direct thrombin inhibitors are non vitamin K antagonist oral anticogulants (NOACs) that provide an alternative treatment to vitamin K antagonists (VKAs) for stroke prevention in AF. Their use has been evaluated in several large clinical trials, but their use around a catheter ablation procedure has not been well evaluated in controlled trials. Therefore, the German Atrial Fibrillation Network association (AFNET) initiated the AXAFA – AFNET 5 trial.
AXAFA – AFNET 5 will evaluate whether anticoagulation with the direct factor Xa inhibitor apixaban is as safe as VKA therapy in patients undergoing catheter ablation of AF in the prevention of peri-procedural complications such as death, stroke, and major bleeding events. The prospective, parallel-group, randomized, open, blinded outcome assessment, multi-center trial will enroll 630 evaluable AF patients who will undergo catheter ablation from 50 study centers – 25 in Europe and 25 in the USA – that routinely perform catheter ablation will enroll the patients after obtaining written informed consent.
The study participants will be randomized to either receive the factor Xa inhibitor apixaban or VKA therapy. Treatment will be initiated 30 days prior to the planned catheter ablation procedure and continued for three months after the procedure, following current consensus recommendations and guidelines. In addition to collecting clinical outcome data (stroke, major bleeding, and other cardiovascular complications), a brain MRI substudy, planned in half of the AXAFA – AFNET 5 patients, will assess the effect of study treatment on silent brain MRI lesions.
The German Atrial Fibrillation Network association (AFNET) initiated the AXAFA – AFNET 5 trial and bears the overall responsibility. The trial is partially funded by the German Centre for Cardiovascular Research (DZHK). The scientific conduct of the trial is overseen by a steering committee consisting of 10 interdisciplinary scientists from Europe and the USA chaired by Prof. Paulus Kirchhof, Birmingham, UK / Münster, Germany, as international chief investigator. Financial support for the conduct of the trial is provided by Bristol-Myers Squibb and Pfizer.
Prof. Kirchhof explains: “So far, we have insufficient data regarding the peri-procedural use of NOACs in patients undergoing catheter ablation. Some retrospective analyses even indicated that there are more complications with NOACs than with VKAs. This is a cause of concern. Hence, there is a need for a well-designed, controlled trial to test whether NOACs can be used in the setting of catheter ablation of AF. AXAFA – AFNET 5 will examine this question.”
About AFNET association
The Atrial Fibrillation Network association (AFNET) is an interdisciplinary research network comprising scientists and physicians from hospitals and practices dedicated to improving the management of atrial fibrillation through coordinated research in Germany and Europe. Its main objective is to conduct high quality investigator-initiated clinical trials and registries on a national and international level. Since January 2015, the AFNET infrastructure and four of the ongoing clinical trials are partially funded by the German Centre for Cardiovascular Research (DZHK). For these trials DZHK funds additional jobs for scientific project management.
The AFNET continues the long-term activities of the network which has been funded by the German Federal Ministry of Research and Education over a decade. The AFNET office o is located in Münster, Germany. The Board of Directors consists of Prof. Günter Breithardt, MD, Münster (Chairman), Prof. Paulus Kirchhof, MD, Münster / Birmingham, UK, Prof. Michael Näbauer, MD, Munich, Prof. Gerhard Steinbeck, MD, Munich.
ISRCTN87711003, NCT 02227550, EudraCT number: 2014-002442-45
Kompetenznetz Vorhofflimmern e.V. (AFNET)
Phone: +49 251 9801340
Angelika Leute, PhD
Phone: +49 202 2623395