Dataset Information

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.

SUBMITTER: Furukawa Y

PROVIDER: S-EPMC7497314 | biostudies-literature | 2020 Oct

REPOSITORIES: biostudies-literature

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Publications

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

Furukawa Yutaka Y Miyake Makoto M Fujita Tomoyuki T Koyama Tadaaki T Takegami Misa M Kimura Tetsuya T Sugio Kumiko K Takita Atsushi A Nishimura Kunihiro K Izumi Chisato C

Cardiovascular drugs and therapy 20200724 5

<h4>Purpose</h4>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.<h4>Methods</h4>This was an observational study, in pa ...[more]

PMID: 32710129

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Project description:Introduction: There were few data about the clinical profiles and long-term outcomes in Chinese patients with atrial fibrillation (AF) and bioprosthetic valves. Methods: The retrospective study enrolled 903 patients with bioprosthetic valve replacement at our hospital and discharged with a diagnosis of AF from January 2010 to December 2018. Results: The median age was 65.6 (61.9-69.1) years, and 548 (60.7%) patients were women. During a follow-up period of 3.84 (2.64-5.51) years, 68 (1.8 per 100 person-years) patients died, 81 (2.1 per 100 person-years) patients developed thromboembolism, and 23 (0.6 per 100 person-years) patients experienced major bleeding. The CHA2DS2-VASc score, as a categorical variable (low, moderate, or high risk), predicted the risk of thromboembolism with the C-statistic of 0.6 (95% CI: 0.511-0.689, p = 0.046). The incidence of the CHA2DS2-VASc score increment was 11.6 per 100 person-years, and the annual reclassification rate of stroke risk (from a low or moderate group to a higher group) was 12.7%. The current proportion of oral anticoagulants was 52.3, 59, and 63.2%, respectively, in the low, moderate, and high stroke risk groups. Age (OR: 1.04, 95% CI: 1.01-1.06, p = 0.01), left atrial size (OR: 1.05, 95% CI: 1.03-1.08, p < 0.001), and rheumatic heart disease (OR: 1.49, 95% CI: 1.05-2.10, p = 0.025) were positively associated with the use of oral anticoagulants. The history of chronic kidney disease (OR: 0.20, 95% CI: 0.05-0.76, p = 0.018), prior surgical ablation (OR: 0.33, 95% CI: 0.24-0.47, p < 0.001), and antiplatelet agent use (OR: 0.08, 95% CI: 0.05-0.13, p < 0.001) were inversely related to the use of oral anticoagulants. Higher admission estimated glomerular filtration rate (HR: 0.515, 95% CI: 0.311-0.853, p = 0.01), left ventricular ejection fraction (HR: 0.961, 95% CI: 0.931-0.992, p = 0.014), concomitant surgical ablation (HR: 0.348, 95% CI: 0.171-0.711, p = 0.004), and rheumatic heart disease history (HR: 0.515, 95% CI: 0.311-0.853, p = 0.01) were associated with a lower risk of death. Surgical ablation (HR: 0.263, 95% CI: 0.133-0.519, p < 0.001) and oral anticoagulants (HR: 0.587, 95% CI: 0.375-0.918, p = 0.019) were related to a lower risk of thromboembolism. Conclusion: Chinese patients with AF and bioprosthetic valve(s) were relatively young and had a high prevalence of rheumatic heart disease with few comorbidities. The percentage of mitral bioprosthetic valve replacement was high. The proportion of concomitant surgical ablation or surgical left atrial appendage occlusion or exclusion was relatively low. The thromboembolic events were the major long-term adverse events. The anticoagulation therapy was underused in patients at moderate or high stroke risk. The CHA2DS2-VASc score was verified to be used for predicting stroke risk in this population. The stroke risk dynamically changed; it needed to be reestimated once the risk factor changed.

Project description:BackgroundAtrial fibrillation is a serious public health problem posing a considerable burden to not only patients, but the healthcare environment due to high rates of morbidity, mortality, and medical resource utilization. There are limited data on the variation in treatment practice patterns across different countries, healthcare settings and the associated health outcomes.Methods/designRHYTHM-AF was a prospective observational multinational study of management of recent onset atrial fibrillation patients considered for cardioversion designed to collect data on international treatment patterns and short term outcomes related to cardioversion. We present data collected in 10 countries between May 2010 and June 2011. Enrollment was ongoing in Italy and Brazil at the time of data analysis. Data were collected at the time of atrial fibrillation episode in all countries (Australia, Brazil, France, Germany, Italy, Netherlands, Poland, Spain, Sweden, United Kingdom), and cumulative follow-up data were collected at day 60 (±10) in all but Spain. Information on center characteristics, enrollment data, patient demographics, detail of atrial fibrillation episode, medical history, diagnostic procedures, acute treatment of atrial fibrillation, discharge information and the follow-up data on major events and rehospitalizations up to day 60 were collected.DiscussionA total of 3940 patients were enrolled from 175 acute care centers. 70.5% of the centers were either academic (44%) or teaching (26%) hospitals with an overall median capacity of 510 beds. The sites were mostly specialized with anticoagulation clinics (65.9%), heart failure (75.1%) and hypertension clinics (60.1%) available. The RHYTHM-AF registry will provide insight into regional variability of antiarrhythmic and antithrombotic treatment of atrial fibrillation, the appropriateness of such treatments with respect to outcomes, and their cost-efficacy. Observations will help inform strategies to improve cardiovascular outcomes in patients with atrial fibrillation.Trial registrationClinical trials NCT01119716.

Dataset Information

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

Purpose

Methods

Results

Conclusion

Trial registration

Publications

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

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