著者

Yugo Yamashita Toshiki Fukasawa Chikashi Takeda Masato Takeuchi Koh Ono Koji Kawakami

出版者

The Japanese Circulation Society

雑誌

Circulation Journal (ISSN:13469843)

巻号頁・発行日

pp.CJ-23-0818, (Released:2023-12-23)

参考文献数

34

被引用文献数

1

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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.

著者

Aki Kuwauchi Satomi Yoshida Shiro Tanaka Sachiko Tanaka Chikashi Takeda Hiroshi Yonekura Isao Nahara Koji Kawakami

出版者

Society for Clinical Epidemiology

雑誌

Annals of Clinical Epidemiology (ISSN:24344338)

巻号頁・発行日

pp.22011, (Released:2022-03-11)

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BackgroundThe controversy concerning the benefits of pulmonary artery catheter (PAC)-based hemodynamic monitoring in cardiac surgeries has not been adequately addressed. This study aims to compare the all-cause mortality between the PAC with venous oxygen saturation monitoring and the Vigileo/FloTrac (FloTrac) system with central venous oxygen saturation monitoring in cardiac surgeries.MethodsThis nationwide retrospective study includes adult patients who underwent elective cardiac surgeries between April 2010 and October 2014, based on the Japanese health insurance claims database. The main outcome was 30-day all-cause mortality. Propensity scores (PS) were used to adjust for the confounding factors. Treatment effects were estimated using multivariable logistic regression analysis, including PS.ResultsA total of 5,838 patients were included in this study. The crude 30-day mortality rates were 2.4% (8/334) and 1.7% (96/5,504) in the FloTrac and PAC groups, respectively. After PS matching, the ORs for 30-day all-cause mortality, in-hospital mortality after PAC placement (vs. FloTrac) were 0.36 (95% CI: 0.05 – 2.37; p= 0.28) and 0.59 (95% CI: 0.16 – 2.20; p= 0.43), respectively. The amount of dobutamine was larger in the PAC group (281±31 mg vs 155±19 mg; p <0.001). There were no significant differences in the amounts of other inotropes, the volume of fluids, or blood transfusions.ConclusionsThe association between PAC (with venous oxygen saturation monitoring) and mortality in patients who underwent elective cardiac surgeries was unclear compared to FloTrac (with central venous oxygen saturation monitoring). Additional investigation is needed to evaluate the benefits of PAC-specific hemodynamic parameters in this population.

著者

Aki Kuwauchi Satomi Yoshida Chikashi Takeda Yugo Yamashita Takeshi Kimura Masato Takeuchi Koji Kawakami

出版者

Japan Epidemiological Association

雑誌

Journal of Epidemiology (ISSN:09175040)

巻号頁・発行日

pp.JE20220360, (Released:2023-04-22)

参考文献数

27

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BackgroundAcute 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.MethodsThe 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 6 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.ResultsA 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% 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 by the diagnosis-based algorithm.ConclusionsThe diagnosis-based algorithm may be a relatively sensitive method for identifying acute PE inpatients in the Japanese DPC database.