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 -
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 -
复制标题
DOI：
10.1253/circj.cj-19-0645
复制
发表时间：
2020-01-01
影响因子：
3.3
通讯作者：
Iizuka, Tomoko
中科院分区：
文献类型：
--
作者：
Nakamura, Masato;Kitazono, Takanari;Iizuka, Tomoko
背景：虽然普拉格雷预防接受经皮冠状动脉介入治疗（PCI）的缺血性心脏病（IHD）患者心血管事件的有效性和安全性已得到证实，但日本独特剂量的长期真实世界数据不足。因此，我们报告了上市后观察性研究 (PRASFIT-Practice II) 1 年随访数据的分析结果。 方法和结果：安全性和有效性分析组包括 4,155 名接受普拉格雷（负荷剂量/维持剂量，20/3.75 mg）作为阿司匹林双重抗血小板治疗 (DAPT) 的 IHD 患者。 360 天（治疗开始后），62.2% 的人继续进行 DAPT。主要不良心血管事件和支架内血栓的累积发生率分别为1.6%和0.2%。心肌梗死溶栓 (TIMI) 大出血和 TIMI 大出血或小出血的累积发生率分别为 1.0% 和 2.0%。治疗前 30 天发生 TIMI 大出血或小出血的危险因素为年龄 >= 80 岁、贫血、女性和肝脏疾病，以及第 31 天至第 12 个月末、高血压和消化性溃疡。 结论：1 年随访结果显示，普拉格雷在日本批准的剂量下用于治疗接受 PCI 的 IHD 患者的长期有效性和安全性。
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.