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

Masato Nakamura, Takanari Kitazono, Ken Kozuma, Toru Sekine, Shinya Nakamura, Kazuhito Shiosakai, Ayumi Tanabe, Tomoko Iizuka

Research output: Contribution to journalArticlepeer-review

Abstract

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. 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. 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.

Original languageEnglish
Pages (from-to)1981-1989
Number of pages9
JournalCirculation Journal
Volume84
Issue number11
DOIs
Publication statusPublished - Oct 23 2020

All Science Journal Classification (ASJC) codes

  • Cardiology and Cardiovascular Medicine

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