AXAFA summary

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 new oral anticoagulants (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. So far, it has not been examined whether NOACs can be used in the setting of catheter ablation of AF.

AXAFA is to test 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 AF patients who will undergo catheter ablation. About 50 study centers – 25 in Europe and 25 in the USA – that routinely perform catheter ablation will enroll the patients after obtaining informed consent.

The study participants will be randomized to either receive the factor Xa inhibitor Apixaban or VKA therapy. They will have to take the medicine for at least 30 days prior to the planned catheter ablation procedure. This interval may be shorter in patients undergoing a transesophageal echocardiogram (TEE) with exclusion of atrial thrombi. In this case the ablation can be performed shortly after the first taking of the medicine. Study medication has to be continued for three months after the ablation procedure. All patients will be treated following the current guidelines.