Prasugrel for Japanese Patients With Ischemic Heart Disease in Long-Term Clinical Practice (PRASFIT-Practice II)　― Final 2-Year Follow-up Results of a Postmarketing Observational Study ―

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  • Nakamura Masato
    Division of Cardiovascular Medicine, Toho University Ohashi Medical Center
  • Kitazono Takanari
    Department of Medicine and Clinical Science, Graduate School of Medical Sciences, Kyushu University
  • Kozuma Ken
    Division of Cardiology, Department of Internal Medicine, Teikyo University
  • Sekine Toru
    Post Marketing Study Department, Daiichi Sankyo Co., Ltd.
  • Nakamura Shinya
    Post Marketing Study Department, Daiichi Sankyo Co., Ltd.
  • Shiosakai Kazuhito
    Clinical Data and Biostatistics Department, Daiichi Sankyo Co., Ltd.
  • Tanabe Ayumi
    Clinical Data and Biostatistics Department, Daiichi Sankyo Co., Ltd.
  • Iizuka Tomoko
    Post Marketing Study Department, Daiichi Sankyo Co., Ltd.

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<p>Background:PRASFIT-Practice II is a postmarketing observational study conducted in 4,155 Japanese patients with ischemic heart disease (IHD) who received long-term prasugrel. The data were used to assess the utility of Academic Research Consortium for High Bleeding Risk (ARC-HBR) criteria.</p><p>Methods and Results:Patients in PRASFIT-practice II were clinically followed for 2 years. The primary endpoint was the cumulative incidence of major adverse cardiovascular events (MACE) and Thrombolysis in Myocardial Infarction (TIMI) major/minor bleeding. Patients were divided into 2 groups based on ARC-HBR criteria (HBR (40.1% of patients) and non-HBR (59.9%)) and the effect of HBR on the primary endpoint was assessed. The median duration of dual antiplatelet therapy with prasugrel was 391.0 days. At 2 years, the cumulative incidence of MACE was 3.3%, and of TIMI major/minor bleeding was 2.7%. At 1 year, MACE and TIMI major/minor bleeding in the HBR group (4.0% and 3.4%, respectively) were higher than that in the non-HBR group (1.3% for both). Landmark analysis at 3 months and 1 year showed that the higher risk of MACE or TIMI major/minor bleeding in the HBR group persisted through 2 years.</p><p>Conclusions:The results of this study confirmed the safety and effectiveness of long-term treatment with prasugrel, and demonstrated that the ARC-HBR criteria for bleeding risk are applicable in Japanese IHD patients treated with prasugrel.</p>

収録刊行物

  • Circulation Journal

    Circulation Journal 84 (11), 1981-1989, 2020-10-23

    一般社団法人 日本循環器学会

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