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 brillation AF. This was a prospective, open-label randomized study assessing the safety and ef cacy 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 signi cantly shorter in the rivaroxaban group than in the warfarin group 6 vs. 8 days ; P 0.0135. The incidence of minor bleeding was signicantly lower in the rivaroxaban group than in the warfarin group 0 vs. 26.6 ; P 0.078. D-dimer concentration was signi cantly 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 signi cantly 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.