Prasugrel for Japanese Patients With Ischemic Heart Disease in Long-Term Clinical Practice (PRASFIT-Practice II)　― 1-Year Follow-up Results of a Postmarketing Observational Study ―

Abstract

Background:Although the effectiveness and safety of prasugrel for the prevention of cardiovascular events in patients with ischemic heart disease (IHD) undergoing percutaneous coronary intervention (PCI) have been demonstrated, long-term real-world data of Japanese unique doses are insufficient. Therefore, we report the results of an analysis of 1-year follow-up data from a postmarketing observational study (PRASFIT-Practice II). Methods and Results:The safety and effectiveness analysis sets included 4,155 IHD patients receiving prasugrel (loading dose/ maintenance dose, 20/3.75 mg) as dual antiplatelet therapy (DAPT) with aspirin. At 360 days (after treatment start), 62.2% continued DAPT. Cumulative incidences of major adverse cardiovascular events and stent thrombosis were 1.6% and 0.2%, respectively. Cumulative incidences of Thrombolysis In Myocardial Infarction (TIMI) major bleeding and TIMI major or minor bleeding were 1.0% and 2.0%, respectively. Risk factors for TIMI major or minor bleeding in the first 30 days of treatment were age ≥80 years, anemia, female sex, and liver disease, and from day 31 to the end of month 12, hypertension and peptic ulcer. Conclusions:The 1-year follow-up results showed long-term effectiveness and safety of prasugrel at dosages approved in Japan for the treatment of IHD patients undergoing PCI.

Application of the Modified High Bleeding Risk Criteria for Japanese Patients in an All-Comers Registry of Percutaneous Coronary Intervention ― From the CREDO-Kyoto Registry Cohort-3 ―

“…Stroke was defined as ischemic or hemorrhagic with neurological symptoms lasting >24 h. To keep consistency with the CREDO-Kyoto PCI/CABG registry cohort-2, 8 bleeding body weight (BW), frailty, heart failure (HF), and peripheral artery disease (PAD), have been reported to be independently associated with bleeding complications, particularly in Japanese. [2][3][4] Therefore, the bleeding risk factors commonly seen in Japanese patients were added to the ARC-HBR criteria and the Japanese version of the HBR (J-HBR) criteria has been proposed by consensus of the Working Group of the Guidelines in the Japanese Circulation Society. 5 However, the prevalence of and the expected bleeding event rate in patients who fulfil the J-HBR criteria are currently unknown.…”

Correlation Between the Japanese Version of the High Bleeding Risk (J-HBR) Criteria and the PRECISE-DAPT Score, and Optimal J-HBR Cut-Off Score to Predict Major Bleeding

“…have been independently associated with bleeding in Japanese people. [4][5][6] Thus, the Japanese version of the HBR criteria (J-HBR) was developed. 7 Consequently, the evaluation of bleeding risk in the 2020 JCS guideline update on antithrombotic therapy in patients with CAD was based on the J-HBR score.…”

Efficacy of the hemostatic device VasoSTAT and the study of hemostatic factor

“…Patient age was not found to be significantly different between the hemostasis success and failure groups but tended to be higher in the latter. In general, due to the fragility of blood vessels and increased prevalence of hypertension, age is regarded as a risk factor for bleeding, as it is in patients undergoing PCI 18 , 19 . Therefore, it is necessary to be watchful of bleeding interventional procedures in elderly patients.…”