Key result
In Japanese patients with ischemic heart disease receiving long-term prasugrel in routine clinical practice, the 2-year cumulative incidence of MACE was 3.3% and TIMI major/minor bleeding was 2.7%, with higher event rates observed in patients meeting high bleeding risk criteria.
Why the study?
Data from patients receiving long-term prasugrel were evaluated to assess the utility of Academic Research Consortium for High Bleeding Risk (ARC-HBR) criteria in Japanese patients with ischemic heart disease.
Does high bleeding risk (ARC-HBR criteria) predict MACE and bleeding in Japanese patients with ischemic heart disease receiving long-term prasugrel?
Observational (n=4,155)
Yes
Does high bleeding risk (ARC-HBR criteria) predict MACE and bleeding in Japanese patients with ischemic heart disease receiving long-term prasugrel?
Long-term prasugrel at the Japanese-approved dose is safe and effective for ischemic heart disease, and ARC-HBR criteria effectively identify patients at higher risk for bleeding and MACE.
ARC-HBR criteria identify higher MACE and bleeding risk on prasugrel; extends applicability to Japanese IHD patients but leaves practice change open.
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.
No takes yet. Share an insight, caveat, or question.
Nakamura et al. (2020) conducted an observational in Ischemic heart disease requiring percutaneous coronary intervention (n=4,155). Prasugrel was evaluated on Cumulative incidence of major adverse cardiovascular events (MACE) at 2 years (95% CI 2.8-3.9). In Japanese patients with ischemic heart disease receiving long-term prasugrel in routine clinical practice, the 2-year cumulative incidence of MACE was 3.3% and TIMI major/minor bleeding was 2.7%, with higher event rates observed in patients meeting high bleeding risk criteria.
Synapse has enriched 5 closely related papers on similar clinical questions. Consider them for comparative context: