Italian Registry in the Setting of Atrial Fibrillation Ablation with Rivaroxaban - IRIS.

Background: Catheter ablation (CA) of atrial fibrillation is routinely used to obtain rhythm control. Evidence suggest that catheter ablation should be done during uninterrupted oral anticoagulation.

Methods: Italian Registry in the setting of atrial fibrillation ablation with rivaroxaban (IRIS) is an Italian multicenter, non-interventional, prospective study which enrolled 250 consecutive atrial fibrillation patients eligible for catheter ablation on rivaroxaban. The decision for rivaroxaban management was left to the physician: uninterrupted or shortly interrupted prior to Catheter ablation. Patients received a follow-up visit at 1 month and 12 months after the procedure.

Results: The primary outcome, represented by all-cause death and systemic embolism at 1 month and 12 months was characterized by one transient ischemic attack and one myocardial infarction in the first 30 days. Both events happened in patients with shortly interrupted strategy (P=0.147), and both in patients who underwent radiofrequency ablation (P=0.737). In the primary safety outcome represented by major bleeding we did not register any event in the 12-month follow-up. The secondary outcome constituted by minor bleeding registered 1 event, after the first 30 days since CA.

Conclusions: IRIS is the biggest real-life data registry regarding CA ablation on rivaroxaban in Italian setting, proving the safety and efficacy of rivaroxaban.