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.

背景： PRASFIT-Practice II 是一项上市后观察性研究，在 4,155 名接受长期普拉格雷治疗的日本缺血性心脏病 (IHD) 患者中进行。这些数据用于评估高出血风险学术研究联盟 (ARC-HBR) 标准的效用。

方法和结果：PRASFIT 实践 II 中的患者临床随访 2 年。主要终点是主要不良心血管事件 (MACE) 和心肌梗死溶栓 (TIMI) 大/小出血的累积发生率。根据 ARC-HBR 标准（HBR（40.1% 的患者）和非 HBR（59.9%））将患者分为 2 组，并评估 HBR 对主要终点的影响。普拉格雷双重抗血小板治疗的中位持续时间为 391.0 天。2 年时，MACE 的累积发生率为 3.3%，TIMI 大/小出血的累积发生率为 2.7%。1 年时，HBR 组的 MACE 和 TIMI 大/小出血（分别为 4.0% 和 3.4%）高于非 HBR 组（均为 1.3%）。

结论：本研究的结果证实了普拉格雷长期治疗的安全性和有效性，并证明了 ARC-HBR 出血风险标准适用于接受普拉格雷治疗的日本 IHD 患者。