Prospective Randomized Study of the Safety and Efficacy of Interrupted Anticoagulant’s Therapy in the Perioperative Period of Catheter Ablation for Atrial Fibrillation: The SEACOAST Rhythm AF Trial

Abstract

No prospective, randomized study has been conducted to date in Japan comparing the use of warfarin and rivaroxaban for preventing thrombotic and bleeding events in the perioperative period of catheter ablation （CA） for atrial fibrillation （AF）. This was a prospective, open-label randomized study assessing the safety and efficacy of warfarin and rivaroxaban in the perioperative period of CA for AF. Thrombotic events including silent cerebral lesion （SCL） detected by magnetic resonance imaging （MRI）, bleeding events, and coagulation test results were assessed in correlation with interrupted warfarin or rivaroxaban in the perioperative period of CA for AF. Finally, thirty-six patients （18 men; aged 65±9.4 years） who underwent CA for AF were prospectively enrolled. No instance of symptomatic cerebral infarction occurred, but 12 of 36 patients （33.3％） showed new SCLs during the postprocedural cerebral MRI examination （8/21 in the rivaroxaban group and 4/15 in the warfarin group; P＝0.47）. The duration of hospitalization was significantly shorter in the rivaroxaban group than in the warfarin group （6 vs. 8 days; P＝0.0135）. The incidence of minor bleeding was significantly lower in the rivaroxaban group than in the warfarin group （0％ vs. 26.6％; P＝0.078）. D-dimer concentration was significantly higher in the SCL group than in the no-SCL group （P＝0.024） under warfarin, while the values of protein S （P＝0.017） and prothrombin time （P＝0.018） were significantly lower in the SCL group than in the no-SCL group under rivaroxaban. Rivaroxaban usage in CA is safer than warfarin usage with respect to the incidence of minor bleeding. In patients receiving rivaroxaban therapy, a lower protein S level may be correlated with the incidence of SCL in CA.