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
| Autor: | Kazuhito Shiosakai, Tomoko Iizuka, Toru Sekine, Masato Nakamura, Ken Kozuma, Shinya Nakamura, Takanari Kitazono, Ayumi Tanabe |
|---|---|
| Rok vydání: | 2020 |
| Předmět: |
medicine.medical_specialty
Prasugrel medicine.medical_treatment Myocardial Infarction Myocardial Ischemia Hemorrhage 030204 cardiovascular system & hematology 03 medical and health sciences 0302 clinical medicine Percutaneous Coronary Intervention Japan Internal medicine medicine Clinical endpoint Product Surveillance Postmarketing Humans Cumulative incidence cardiovascular diseases 030212 general & internal medicine Myocardial infarction business.industry Percutaneous coronary intervention General Medicine Thrombolysis medicine.disease Treatment Outcome Cardiology and Cardiovascular Medicine business Prasugrel Hydrochloride TIMI Mace Platelet Aggregation Inhibitors medicine.drug Follow-Up Studies |
| Zdroj: | Circulation journal : official journal of the Japanese Circulation Society. 84(11) |
| ISSN: | 1347-4820 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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