Catheter Ablation -> Atrial Fibrillation & Atrial Flutter: -> Quality Measures & Complications D-PO04 - Poster Session IV (ID 15) Poster

D-PO04-203 - Reevaluation For Duration Of Anticoagulation In Blanking Period Of Af Ablation (new Reducible) Trial (ID 1235)


Background: At least two months of anticoagulation is recommended after radiofrequency catheter ablation (RFCA) of atrial fibrillation (AF). However, the risk of thromboembolic events after RFCA is very low with most events occurring within 2 weeks after the procedure.
Objective: We hypothesized that non-vitamin K antagonist oral anticoagulants (NOAC) use for the first one month after the RFCA for patients with paroxysmal AF and low thromboembolic risk would be sufficient compared to conventional NOAC use for 2 months.
Methods: This trial was a multi-center, non-blinded, open label phase 3 clinical trial. Only patients with paroxysmal AF and CHA2DS2-VASc score of 0 or 1 were enrolled. Patients were randomized to either one month NOAC group or two months NOAC group. Primary outcome endpoint was thromboembolic and major bleeding events during 2 month of follow-up.
Results: A total of 242 patients who underwent RFCA for AF were randomized. Mean age and CHA2DS2-VASc score were 52.93 ± 9.78 and 0.51 ± 0.65. During 2 months of follow-up, no thromboembolic event occurred in both groups (0% vs. 0%; p > 0.999). No major bleeding was observed with both groups (0% vs. 0%; p > 0.999). Hematoma not requiring transfusion or additional hospitalization occurred in six patients: two patient in one month group and four patients in two months group.
Conclusion: One month anticoagulation with NOAC after RFCA in patients with paroxysmal AF and CHA2DS2-VASc score of 0 or 1 showed similar efficacy and safety compared to standard 2 months NOAC use.