Rationale, Design, and Baseline Characteristics of the BioProsthetic Valves with Atrial Fibrillation (BPV-AF) Study

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

The Characteristics, Long-Term Outcomes, Risk Factors, and Antithrombotic Therapy in Chinese Patients With Atrial Fibrillation and Bioprosthetic Valves

“…The clinical characteristics in our study were different from those reported in previous studies ( 6 , 7 , 10 , 11 ). Patients were younger in our study than those in previous studies.…”

“…The related reasons might be as follows: first, the enrollment in the present study was based on the patients who underwent BVR at our hospital and discharged with AF diagnosis. The patients who developed AF after the BPV were not included, which was the enrollment criteria for the BPV-AF study ( 7 ), and these patients were generally older and had more comorbidities than patients in our study. Second, according to the Cardiovascular Surgery Outcomes 2019 published by Fuwai Hospital ( 19 ), which is the largest medical center for cardiovascular diseases in China, the proportion of the application of BPVs was only 20%, significantly lower than that in other countries.…”

“…Thus, the number of patients with BPV and AF is increasing. Previous studies focused on the management of AF and enrolled only a few patients with both AF and BPVs, and the sample size was small (6)(7)(8)(9)(10)(11)(12)(13)(14)(15)(16). The risk factors of thromboembolism and mortality in such population were also unknown.…”

Impact of mitral versus aortic bioprosthetic valve position on thromboembolism and bleeding risk in patients with atrial fibrillation

“…Prospective large-sample studies analyzing nationwide Japanese data are warranted. A large-scale prospective registry study (UMIN0 0 0 034485) in patients with AF with bioprosthetic valves is currently in progress [21] .…”

Additional Effects of Antiplatelet Therapy on Anticoagulant Agents in Patients With Bioprosthetic Valves and Atrial Fibrillation

“…A large-scale prospective study (UMIN000034485) in AF patients with bioprosthetic valves is currently in progress. 35 efficacy events without increasing safety outcomes by adding SAPT on anticoagulant therapy. Moreover, there is a possibility that the clinical backgrounds may be different between patients after bioprosthetic valve replacement and those with lone AF.…”