Background:The current status and outcomes of direct oral anticoagulant (DOAC) use have not been widely evaluated in unselected patients with atrial fibrillation (AF) in the real world.Methods and ...Results:The Fushimi AF Registry is a community-based prospective survey of AF patients who visited the participating medical institutions (n=80) in Fushimi, Kyoto, Japan. Follow-up data with oral anticoagulant (OAC) status were available for 3,731 patients by the end of November 2015. We evaluated OAC status and clinical outcomes according to OAC status. The number (incidence rate) of stroke/systemic embolism (SE) and major bleeding events during the median follow-up of 3.0 years was 224 (2.3%/year) and 177 (1.8%/year), respectively. After the release of DOAC, the prevalence of DOAC use increased gradually and steadily, and that of warfarin, DOAC and no OAC was 37%, 26% and 36%, respectively in 2015. On Cox proportional hazards modeling incorporating change in OAC status as a time-dependent covariate for stroke/SE and major bleeding events, use of DOAC compared with warfarin was not associated with stroke/SE events (HR, 0.95; 95% CI: 0.59–1.51, P=0.82) or major bleeding events (HR, 0.82; 95% CI: 0.50–1.36, P=0.45).Conclusions:In real-world clinical practice, there were no significant differences in stroke/SE events or major bleeding events for DOAC compared with warfarin in patients with AF.
•Venous thromboembolism (VTE) is becoming a common issue in Japan.•The management strategies of VTE have changed dramatically in the past decade.•Direct oral anticoagulants could provide unique ...treatment strategies for VTE.•There are still a number of uncertain issues for VTE.•Future research is needed especially for cancer-associated VTE and minor VTE.
Clinicians have been more and more often encountering patients with venous thromboembolism (VTE), including pulmonary embolism and deep vein thrombosis, leading to the increased importance of VTE in daily clinical practice. VTE is becoming a common issue in Asian countries including Japan. The management strategies of VTE have changed dramatically in the past decade including the introduction of direct oral anticoagulants (DOACs). In addition, there have been several landmark clinical trials assessing acute treatment strategies including thrombolysis and inferior vena cava (IVC) filter. The current VTE guidelines do not recommend the routine use of thrombolysis or IVC filters based on recent evidence; Nevertheless, the prevalence of thrombolysis and IVC filter use in Japan was strikingly high. The novel profiles of DOACs with rapid onset of action and potential benefit of a lower risk for bleeding compared with vitamin K antagonist could make home treatment feasible and is safer even with extended anticoagulation therapy. One of the most clinically relevant issues for VTE treatment is optimal duration of anticoagulation for the secondary prevention of VTE. Considering recent evidence, optimal duration of anticoagulation should be determined based on the risk for recurrence as well as the risk for bleeding in an individual patient. Despite the recent advances for VTE management, there are still a number of uncertain issues that challenge clinicians in daily clinical practice, such as cancer-associated VTE and minor VTE including subsegmental pulmonary embolism and distal deep vein thrombosis, warranting future research. Several clinical trials are now ongoing for these issues, globally as well as in Japan. The current review is aimed to overview the recent advances in VTE management, describe the current status including some domestic issues in Japan, and discuss the future perspective of VTE.
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Coronavirus disease 2019 (COVID-19) has become a major health problem worldwide since 2020. Although the main pathophysiology of COVID-19 is a respiratory infectious disease, it could also cause ...cardiovascular complications, including thrombosis. Thus, anticoagulation therapy has been thought to help prevent thrombosis, leading to improved survival. However, to date, several aspects of the optimal anticoagulation strategies for COVID-19 remain unclear. Considering the status of COVID-19-related thrombosis and some domestic issues in Japan, the optimal anticoagulation strategies for COVID-19 might have to be based on Japanese domestic clinical data considering racial difference. Racial disparities in terms of thromboembolic risk have been well known in the pre-COVID-19 era, and the risk of COVID-19-associated thrombosis depending on race could be an important issue. Considering a potential higher risk of bleeding with anticoagulation therapy in the Asian population, it might be important to maintain a good balance between the risks of thrombosis and bleeding. Latest evidences of COVID-19-related thrombosis and anticoagulation strategies, including some domestic issues in Japan, showed a different status of COVID-19-related thrombosis in Japan from that in Western countries, suggesting the potential benefit of different anticoagulation strategies, specifically for the Japanese population. Although these insights could be useful for the consideration of anticoagulation strategies for the Japanese population, the final decision should be based on balancing the benefits and risks of anticoagulation therapy in each patient.
Background: The effectiveness and safety of edoxaban for venous thromboembolism (VTE) in unselected real-world patients have not been fully evaluated.Methods and Results: In the Japanese nationwide ...administrative database, we identified 6,262 VTE patients in whom edoxaban was initiated; these patients were divided into 3 groups based on their index doses: 15 mg/day (n=235), 30 mg/day (n=4,532), and 60 mg/day (n=1,495). We evaluated patient characteristics, recurrent VTEs, and a composite endpoint of intracranial hemorrhage (ICH) and gastrointestinal (GI) bleeding. Patient characteristics among the 15-, 30-, and 60-mg edoxaban groups varied widely regarding several aspects, including age (mean 81.0, 76.2, and 65.0 years, respectively) and body weight (mean 49.5, 51.8, and 70.3 kg, respectively). At 180 days, the cumulative incidence of recurrent VTEs in the 15-, 30-, and 60-mg edoxaban groups was 4.4%, 2.6%, and 1.8%, respectively, whereas that of ICH or GI bleeding was 7.3%, 5.4%, and 3.3%, respectively. Subgroup analyses showed that the cumulative incidence of ICH or GI bleeding in patients in the 15-mg edoxaban group was 3.6% for patients aged ≥80 years, 8.4% for those with a body weight <60 kg, and 31.3% for those with renal dysfunction.Conclusions: Only a minority of patients with VTEs received a super low dose (15 mg) of edoxaban, and these patients may be at higher risk of bleeding as well as VTE recurrence.
Background: Acute pulmonary embolism (PE) is a life-threatening in-hospital complication. Recently, several studies have reported the clinical characteristics of PE among Japanese patients using the ...diagnostic procedure combination (DPC)/per diem payment system database. However, the validity of PE identification algorithms for Japanese administrative data is not yet clear. The purpose of this study was to evaluate the validity of using DPC data to identify acute PE inpatients.Methods: The reference standard was symptomatic/asymptomatic PE patients included in the COntemporary ManageMent AND outcomes in patients with Venous ThromboEmbolism (COMMAND VTE) registry, which is a cohort study of acute symptomatic venous thromboembolism (VTE) patients in Japan. The validation cohort included all patients discharged from the six hospitals included in both the registry and DPC database. The identification algorithms comprised diagnosis, anticoagulation therapy, thrombolysis therapy, and inferior vena cava filter placement. Each algorithm’s sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) were estimated.Results: A total of 43.4% of the validation cohort was female, with a mean age of 67.3 years. The diagnosis-based algorithm showed a sensitivity of 90.2% (222/246; 95% confidence interval CI, 85.8–93.6%), a specificity of 99.8% (228,485/229,027; 95% CI, 99.7–99.8%), a PPV of 29.1% (222/764; 95% CI, 25.9–32.4%) and an NPV of 99.9% (228,485/229,509; 95% CI, 99.9–99.9%) for identifying symptomatic/asymptomatic PE. Additionally, 94.6% (159/168; 95% CI, 90.1–97.5%) of symptomatic PE patients were identified using the diagnosis-based algorithm.Conclusion: The diagnosis-based algorithm may be a relatively sensitive method for identifying acute PE inpatients in the Japanese DPC database.
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