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 ―
Key result
Real-world Japanese prasugrel post-PCI linked to ~3% non-CABG bleeding and ~1% MACE at 3 months.
- n=4,157
Why the study?
Real-world data for prasugrel at the unique dose approved for Japanese patients with ischemic heart disease are limited, necessitating large-scale observational data.
Is prasugrel safe and effective in Japanese patients with ischemic heart disease undergoing percutaneous coronary intervention in real-world clinical practice?
Population
4,157 Japanese patients with ischemic heart disease undergoing PCI
Comparison
Prasugrel treatment at unique Japanese dose
Design
2-year observational study with interim analysis
Follow-up
3 months
Authors
Discussion
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Member takes
Implication
Supports short-term safety of Japan-specific prasugrel post-PCI in real-world Japanese patients; leaves open need for randomized confirmation.
Study Design
Type
Observational (n=4,157)
Multicenter
Yes
Structured PICO
Is prasugrel safe and effective in Japanese patients with ischemic heart disease undergoing percutaneous coronary intervention in real-world clinical practice?
P
Population
4,157 Japanese patients (mean age 68.3 years, 23.5% female) with ischemic heart disease undergoing percutaneous coronary intervention, treated with prasugrel and followed for a median of 112 days.
E
Exposure
Prasugrel (unique dose approved for Japanese patients)
O
Outcome
Safety (non-coronary artery bypass grafting-related bleeding adverse events, TIMI major and minor bleeding) and effectiveness (major adverse cardiovascular events [MACE], stent thrombosis)safety
Prasugrel at the Japan-specific dose appears safe and effective during the early phase of treatment in real-world Japanese patients with IHD undergoing PCI.
Limitations
- Observational study without control groups
- Short observation period due to being a 3-month interim analysis
- Direct comparisons with previous clinical trials are difficult because of differences in observation periods, patient backgrounds, and exclusion criteria
- Bleeding adverse events classification excluded bleeding occurring during invasive procedures such as PCI
Cite This Study
Nakamura et al. (2019) conducted an observational in Ischemic heart disease (IHD) requiring percutaneous coronary intervention (PCI) (n=4,157). Prasugrel was evaluated on Incidence of non-CABG-related bleeding adverse events. In Japanese patients with ischemic heart disease undergoing percutaneous coronary intervention in real-world practice, prasugrel treatment was associated with a 3.1% incidence of non-CABG-related bleeding adverse events and a 1.0% incidence of major adverse cardiovascular events at 3 months.