Registry of antithrombotic therapy in atrial fibrillation patients with bioprosthetic valves: A retrospective observational study

Izumi, Chisato; Miyake, Makoto; Amano, Masashi; Kitai, Takeshi; Obayashi, Yuki; Takegami, Misa; Kimura, Takeshi; Sugio, Kumiko; Matsumoto, Teruyuki; Nishimura, Kunihiro; Furukawa, Yutaka

doi:10.1016/j.jjcc.2020.02.006

Cited by 12 publications

(20 citation statements)

References 18 publications

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“…In comparison with the recent publication from the retrospective BPV-AF registry, in which just 7.5% (16/214) of evaluable patients received DOACs [15], 29.3% (263/899) of patients in our study were found to be treated with DOAC-based therapy at baseline. This difference is likely owing to the timing of the two studies; in the retrospective analysis, we can infer a slow uptake of DOACs in the first few years after approvals were obtained, whereas a higher rate of DOAC prescription is found in current clinical practice.…”

Section: Discussioncontrasting

confidence: 56%

“…Furthermore, clinical study data in this population are limited and come primarily from Caucasian patients [10,11], which may not reflect the experience in Japanese clinical practice. Data in Japanese patients with AF who have undergone BPV implantation were recently reported from a small-scale retrospective analysis [15], but prospective analyses in the Japanese real-world clinical population are still required to fill the evidence gap. Moreover, although bleeding data have been reported for Asian patients living in the USA [14], it is widely accepted that residential location can have a strong influence on health outcomes (in terms of medical care, environment, and socioeconomic factors).…”

Section: Discussionmentioning

confidence: 99%

“…We acknowledge that there may be bias inherent in the requirement for 1 year of follow-up data which results in the exclusion of patients with shorter data intervals who may have more severe complications. However, as the study was initiated after DOACs became available in Japan (the first approvals were obtained in 2011 [22]), it will provide the most up-to-date information on the usage of anticoagulants in the real world and deliver a counterpoint to the recent retrospective BPV-AF analysis [15].…”

Section: Strengths and Limitationsmentioning

confidence: 99%

“…Recently, we reported the status and outcomes of patients with BPV replacement and AF in real-world clinical practice [15]. However, that analysis utilized a retrospective, observational design and had a relatively small sample size, and very few patients treated with DOACs were included.…”

Section: Introductionmentioning

confidence: 99%

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

Furukawa

Miyake

Fujita

et al. 2020

Cardiovasc Drugs Ther

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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

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Section: Discussioncontrasting

confidence: 56%

Section: Discussionmentioning

confidence: 99%

Section: Strengths and Limitationsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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

Furukawa

Miyake

Fujita

et al. 2020

Cardiovasc Drugs Ther

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“…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.…”

Section: Introductionmentioning

confidence: 99%

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

Ren

Yang

Zhu

et al. 2021

Front. Cardiovasc. Med.

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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.

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Direct Oral Anticoagulation Versus Warfarin in Patients with Atrial Fibrillation and Bioprosthetic Heart Valves: a Retrospective, Real-World Cohort Study

Eikelboom

Whitlock

Sibilio

et al. 2022

Cardiovasc Drugs Ther

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Registry of antithrombotic therapy in atrial fibrillation patients with bioprosthetic valves: A retrospective observational study

Cited by 12 publications

References 18 publications

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

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

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

Direct Oral Anticoagulation Versus Warfarin in Patients with Atrial Fibrillation and Bioprosthetic Heart Valves: a Retrospective, Real-World Cohort Study

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