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Efficacy and Safety of Uninterrupted Periprocedural Edoxaban in Patients Undergoing Catheter Ablation for Atrial Fibrillation　- The Prospective KYU-RABLE Study.
Takahashi, Naohiko; Mukai, Yasushi; Kimura, Tetsuya; Yamaguchi, Keita; Matsumoto, Takuyuki; Origasa, Hideki; Okumura, Ken.
Afiliación
  • Takahashi N; Department of Cardiology and Clinical Examination, Oita University Faculty of Medicine.
  • Mukai Y; Cardiology Division, Japanese Red Cross Fukuoka Hospital.
  • Kimura T; Medical Science Department, Daiichi Sankyo Co., Ltd.
  • Yamaguchi K; Medical Science Department, Daiichi Sankyo Co., Ltd.
  • Matsumoto T; Safety and Risk Management Department, Daiichi Sankyo Co., Ltd.
  • Origasa H; Division of Biostatistics and Clinical Epidemiology, University of Toyama Graduate School of Medicine and Pharmaceutical Sciences.
  • Okumura K; Division of Cardiology, Saiseikai Kumamoto Hospital Cardiovascular Center.
Circ J ; 83(10): 2017-2024, 2019 09 25.
Article en En | MEDLINE | ID: mdl-31511436
BACKGROUND: The KYU-RABLE study, a prospective, multicenter, single-arm interventional study, evaluated the efficacy and safety of uninterrupted oral edoxaban in patients undergoing catheter ablation (CA) for atrial fibrillation (AF).Methods and Results:We enrolled patients with AF from 23 centers in Japan. Edoxaban 60 mg (30 mg in patients indicated for dose adjustment) was administered uninterrupted, once daily in the morning for ≥4 weeks before CA and 4 weeks ±7 days after CA with one dose delayed on the procedural day. The primary endpoint was a composite of thromboembolism and major bleeding during 4 weeks from the procedural day. Among the 513 eligible patients who underwent CA, 63.5% received edoxaban 60 mg/day and 36.1% received 30 mg/day. For the primary endpoint, no thromboembolism and 1 major bleeding event (0.2%, cardiac tamponade) were observed. The plasma edoxaban concentration decreased depending on the time from the last administration to the CA procedure. However, plasma levels of coagulative biomarkers were within appropriate ranges regardless of the interval from the last administration of edoxaban. CONCLUSIONS: The present study provided evidence of the efficacy and safety of uninterrupted edoxaban administered once daily in the morning, with one dose delayed on procedural day, in patients with AF undergoing CA. Edoxaban was associated with a low risk of periprocedural thromboembolic and bleeding complications.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Piridinas / Fibrilación Atrial / Tiazoles / Tromboembolia / Coagulación Sanguínea / Ablación por Catéter / Inhibidores del Factor Xa Tipo de estudio: Clinical_trials / Diagnostic_studies / Etiology_studies / Observational_studies / Risk_factors_studies Límite: Aged / Female / Humans / Male / Middle aged País/Región como asunto: Asia Idioma: En Revista: Circ J Asunto de la revista: ANGIOLOGIA / CARDIOLOGIA Año: 2019 Tipo del documento: Article Pais de publicación: Japón
Texto completo
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Piridinas / Fibrilación Atrial / Tiazoles / Tromboembolia / Coagulación Sanguínea / Ablación por Catéter / Inhibidores del Factor Xa Tipo de estudio: Clinical_trials / Diagnostic_studies / Etiology_studies / Observational_studies / Risk_factors_studies Límite: Aged / Female / Humans / Male / Middle aged País/Región como asunto: Asia Idioma: En Revista: Circ J Asunto de la revista: ANGIOLOGIA / CARDIOLOGIA Año: 2019 Tipo del documento: Article Pais de publicación: Japón