Prasugrel for Japanese Patients With Ischemic Heart Disease in Long-Term Clinical Practice (PRASFIT-Practice II)　― A 3-Month Interim Analysis of a Postmarketing Observational Study ―

Abstract

Background: A unique dose of prasugrel has been approved exclusively for Japanese patients, but real-world data for prasugrel at that dose in patients with ischemic heart disease (IHD) are limited. Therefore, large-scale, real-world data are needed. Methods and Results: A 2-year observational study of Japanese patients with IHD undergoing percutaneous coronary intervention and being treated with prasugrel to evaluate safety and effectiveness. This report is an interim analysis of data from case report forms (CRFs) after 3 months. CRFs were collected from 4,270 patients, 4,157 of whom were eligible for the safety and effectiveness analysis sets (mean age, 68.3 years; male, 76.5%). The median treatment period was 112 days, and 92.3% of patients continued treatment with prasugrel. The incidence of non-coronary artery bypass grafting-related bleeding adverse events (AEs) was 3.1%, of which Thrombolysis in Myocardial Infarction (TIMI) major and minor bleeding accounted for 0.5% and 0.6%, respectively. The most common bleeding AEs were gastrointestinal disorders, which accounted for 43.2% of the sum of "TIMI major and minor bleeding AEs". The incidence of major adverse cardiovascular events (MACE) was 1.0%, and the cumulative incidence of MACE was 1.4%. The incidence of stent thrombosis was 0.2%. Conclusions: Interim study results indicated that prasugrel was safe and effective during the early phase of treatment in Japanese patients with IHD in real-world clinical settings.

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 ―

“…A possible reason for this finding is that in the present analysis, after the initial PCI, only 2 patients experienced bleeding (TIMI major or minor bleeding) at the puncture site. 5 This may be because, although the femoral artery has been chosen as the principal access site for PCI in the past, recently the radial artery is increasingly chosen, as the transradial approach is a safe alternative, leading to reductions in mortality, major bleeding complications, MACE and vascular complications compared with the femoral artery approach. 11 This explanation is consistent with our interpretation of the results of the previous 3-month interim analysis.…”

“…11 This explanation is consistent with our interpretation of the results of the previous 3-month interim analysis. 5 However, approximately 25% of the bleeding AEs occurred during the early treatment phase. Therefore, further inhibition of bleeding AEs during this period is deemed critical for reducing the incidence of bleeding AEs during the treatment.…”

“…9, 10 In the previous PRASFIT-Practice II interim analysis, multivariate analyses of risk factors for cardiovascular events were carried out for all cardiovascular events. 5 In contrast, in the present analysis we focused on the risk of MACE, because these are considered more severe and clinically important than other cardiovascular events. The results indicated that CCr <30 mL/min, prior MI, prior ischemic stroke, and anemia were risk factors for MACE.…”

“…Prasugrel (initial loading dose [LD]/maintenance dose [MD], 60/10 mg) has been shown by the results of the Trial to Assess Improvement in Therapeutic Outcomes by Optimizing Platelet Inhibition with Prasugrel-Thrombolysis In Myocardial Infarction (TRITON-TIMI) 38, a multinational phase III trial conducted in Europe and the USA, to reduce the incidence of ischemic cardiovascular events in patients with acute coronary syndrome (ACS), as compared with clopidogrel (LD/MD, 300/75 mg); however, the inci-prasugrel to be effective and with a good safety profile based on the incidence of acute cardiovascular events and bleeding AEs during the PCI perioperative period, respectively. 5 Here, we report the results of an analysis of the 1-year data on the effectiveness and safety of prasugrel, as well as the factors associated with the discontinuation of dual antiplatelet therapy (DAPT).…”

JCS 2020 Guideline Focused Update on Antithrombotic Therapy in Patients With Coronary Artery Disease

“…Gastrointestinal bleeding or urinary tract bleeding requiring hospitalization or transfusion in the past 6 months or at any time, if recurrent. 5,36,37 First non-traumatic bleeding event requiring hospitalization or transfusion in the past 6-12 months.…”