Rationale, Design, and Baseline Characteristics of the BioProsthetic Valves with Atrial Fibrillation (BPV-AF) Study
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ORIGINAL ARTICLE
Rationale, Design, and Baseline Characteristics of the BioProsthetic Valves with Atrial Fibrillation (BPV-AF) Study Yutaka Furukawa 1 & Makoto Miyake 2 & Tomoyuki Fujita 3 & Tadaaki Koyama 4 & Misa Takegami 5 & Tetsuya Kimura 6 & Kumiko Sugio 6 & Atsushi Takita 7 & Kunihiro Nishimura 5 & Chisato Izumi 8 & for the BPV-AF Registry group Accepted: 13 July 2020 # The Author(s) 2020
Abstract Purpose To date, clinical data on real-world treatment practices in Japanese patients with atrial fibrillation (AF) after bioprosthetic valve (BPV) replacement are needed. We conducted a large-scale, prospective, multicenter study to understand the actual usage of antithrombotic therapy and the incidence of thromboembolic and bleeding events in these patients, and to eliminate the clinical data gap between Japan and Western countries. Methods This was an observational study, in patients who had undergone BPV replacement and had a confirmed diagnosis of AF, with no mandated interventions. We report the baseline demographic and clinical data for the 899 evaluable patients at the end of the enrollment period. Results Overall, 45.7% of patients were male; the mean age was 80.3 years; AF was paroxysmal, persistent, or permanent in 36.9%, 34.6%, and 28.5% of patients, respectively. Mean risk scores for stroke and bleeding were 2.5 (CHADS2), 4.1 (CHA2DS2-VASc), and 2.5 (HAS-BLED). Many patients (76.2%) had comorbid hypertension and 54.8% had heart failure. Most BPVs (65.5%) were positioned in the aortic valve. Warfarin-based therapy, direct oral anticoagulant (DOAC)-based therapy, and antiplatelet therapy (without warfarin and DOAC) were administered to 55.0%, 29.3%, and 9.7% of patients, respectively. Conclusion Patients enrolled into this study are typical of the wider Japanese AF/BPV population in terms of age and clinical history. Future data accruing from the observational period will contribute to future treatment recommendations and guide therapeutic decisions in patients with BPV and AF. Trial registration ClinicalTrials.gov Identifier: UMIN000034485 Keywords Atrial fibrillation . Valvular heart disease . Bioprosthetic valve replacement . Antithrombotic therapy . Thromboembolism . Bleeding
Details of all investigators in the BPV-AF Registry group are provided in Online Resource 1. Electronic supplementary material The online version of this article (https://doi.org/10.1007/s10557-020-07038-1) contains supplementary material, which is available to authorized users. * Yutaka Furukawa [email protected] 1
Department of Cardiovascular Medicine, Kobe City Medical Center General Hospital, Kobe, Japan
2
Department of Cardiology, Tenri Hospital, Tenri, Japan
3
Cardiovascular Surgery Department, National Cerebral and Cardiovascular Center, Suita, Japan
4
Department of Cardiovascular Surgery, Kobe City Medical Center General Hospital, Kobe, Japan
5
Department of Preventive Medicine and Epidemiologic Informatics, National Cerebral and Cardiovascular Center, Suita, Japan
6
Medical Science Department, Daiichi Sankyo
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