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

N. Watanabe, Ko Ogawa, Yuuya Nakamura, Kouichirou Inoguchi, Akinori Ochi, Yuuta Chiba, Yoshimi Oonishi, Shirou Kawasaki, Masayoshi Oonuma, T. Itou, Tatsuya Onuki, T. Adachi, Youichi Kobayashi
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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. 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. 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.
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心房颤动导管消融围手术期中断抗凝治疗的安全性和有效性的前瞻性随机研究:SEACOAST节律性心房颤动试验
迄今为止,在日本尚未进行前瞻性随机研究,比较华法林和利伐沙班在房颤(AF)导管消融(CA)围手术期预防血栓和出血事件的使用。这是一项前瞻性、开放标签随机研究,评估华法林和利伐沙班在房颤CA围手术期的安全性和有效性。通过磁共振成像(MRI)检测到的血栓性事件,包括无症状脑损伤(SCL)、出血事件和凝血试验结果,评估与房颤CA围手术期华法林或利伐沙班中断的相关性。年龄65±9.4岁,因房颤接受CA治疗的患者前瞻性入选。出现症状性脑梗死,但36例患者中有12例(33.3%)在术后脑MRI检查中出现新的scl(利伐沙班组8/21,华法林组4/15);P = 0.47)。利伐沙班组住院时间明显短于华法林组(6天vs. 8天;P = 0.0135)。利伐沙班组轻度出血发生率显著低于华法林组(0比26.6%;P = 0.078)。华法林作用下SCL组d -二聚体浓度显著高于无SCL组(P = 0.024),利伐沙班作用下SCL组蛋白S值(P = 0.017)和凝血酶原时间(P = 0.018)显著低于无SCL组。就轻微出血的发生率而言,CA比华法林更安全。在接受利伐沙班治疗的患者中,较低的蛋白S水平可能与CA中SCL的发生率相关。
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