Chisato Izumi1, Makoto Miyake2, Masashi Amano3, Takeshi Kitai4, Yuki Obayashi2, Misa Takegami5, Tetsuya Kimura6, Kumiko Sugio6, Takuyuki Matsumoto7, Kunihiro Nishimura5, Yutaka Furukawa4. 1. Department of Cardiovascular Medicine, National Cerebral and Cardiovascular Center, Osaka, Japan. Electronic address: izumi-ch@ncvc.go.jp. 2. Department of Cardiology, Tenri Hospital, Nara, Japan. 3. Department of Cardiovascular Medicine, National Cerebral and Cardiovascular Center, Osaka, Japan. 4. Department of Cardiovascular Medicine, Kobe City Medical Center General Hospital, Kobe, Japan. 5. Department of Preventive Medicine and Epidemiology, National Cerebral and Cardiovascular Center, Osaka, Japan. 6. Medical Science Department, Daiichi Sankyo Co., Ltd., Tokyo, Japan. 7. Safety and Risk Management Department, Daiichi Sankyo Co., Ltd., Tokyo, Japan.
Abstract
BACKGROUND: The incidence of cardiovascular diseases, including valvular heart disease and atrial fibrillation (AF), is rising as the elderly population increases. For patients with AF and bioprosthetic valves, current treatment guidelines for antithrombotic therapy vary by country, likely due to a lack of robust study data. METHODS: We conducted a multicenter, retrospective, observational analysis of 214 Japanese AF patients after bioprosthetic valve replacement in real-world clinical practice. The primary efficacy endpoint was the incidence of stroke/systemic embolism, and the primary safety endpoint was major bleeding. RESULTS: The mean observation period was 46.0 months. Warfarin was administered to 176 patients (82.2%), direct oral anticoagulants (DOAC) to 16 patients (7.5%), and antiplatelet drugs to 13 patients (6.1%). The number of patients who were treated with DOAC was increasing in the later period of registration. Stroke/systemic embolism was observed in 14 patients [1.77 patients/100 person-years (PY)]. Major bleeding was observed in 22 patients (2.83/100 PY). CONCLUSIONS: In a current real-world setting in Japan, warfarin was the most commonly used treatment in AF patients with bioprosthetic valves, but there was an increasing trend of DOAC-treated patients. Further investigations are needed to confirm the efficacy and safety of DOAC in patients with bioprosthetic valves.
BACKGROUND: The incidence of cardiovascular diseases, including valvular heart disease and atrial fibrillation (AF), is rising as the elderly population increases. For patients with AF and bioprosthetic valves, current treatment guidelines for antithrombotic therapy vary by country, likely due to a lack of robust study data. METHODS: We conducted a multicenter, retrospective, observational analysis of 214 Japanese AFpatients after bioprosthetic valve replacement in real-world clinical practice. The primary efficacy endpoint was the incidence of stroke/systemic embolism, and the primary safety endpoint was major bleeding. RESULTS: The mean observation period was 46.0 months. Warfarin was administered to 176 patients (82.2%), direct oral anticoagulants (DOAC) to 16 patients (7.5%), and antiplatelet drugs to 13 patients (6.1%). The number of patients who were treated with DOAC was increasing in the later period of registration. Stroke/systemic embolism was observed in 14 patients [1.77 patients/100 person-years (PY)]. Major bleeding was observed in 22 patients (2.83/100 PY). CONCLUSIONS: In a current real-world setting in Japan, warfarin was the most commonly used treatment in AFpatients with bioprosthetic valves, but there was an increasing trend of DOAC-treated patients. Further investigations are needed to confirm the efficacy and safety of DOAC in patients with bioprosthetic valves.