Department of Cardiology, Kurashiki Central Hospital.
Circ J. 2018 Jun 25;82(7):1874-1883. doi: 10.1253/circj.CJ-18-0114. Epub 2018 Apr 26.
Data on bleeding events in Japanese patients with acute coronary syndrome (ACS) are insufficient. In addition, the efficacy and safety of a maintenance dose of prasugrel 2.5 mg/day in high bleeding risk patients are unknown.
We prospectively enrolled 1,167 consecutive patients with suspected ACS and undergoing percutaneous coronary intervention. The maintenance dose of prasugrel 2.5 mg/day was prescribed for patients with a low body weight (≤50 kg), elderly (≥75 years), or renal insufficiency (eGFR ≤30 mL/min/1.73 m). In-hospital events were assessed in 992 ACS patients treated with drug-eluting stents. Excluding 29 in-hospital deaths, out-of-hospital events were assessed in 963 ACS patients. The primary safety outcome measure was major bleeding (Bleeding Academic Research Consortium types 3 and 5). The incidence of in-hospital major bleeding was 3.4%. Multivariate analysis showed that being elderly, low body weight, renal insufficiency, stroke history, femoral approach, and mechanical support usage were independent predictors of in-hospital major bleeding. The cumulative 1-year incidence of out-of-hospital major bleeding was not significantly different between the prasugrel 2.5 mg/day (n=284) and 3.75 mg/day (n=487) groups (1.6% vs. 0.7%, log-rank P=0.24). That of out-of-hospital definite or probable stent thrombosis was 0% in both groups.
The maintenance dose of adjusted prasugrel 2.5 mg/day seems to be one option in ACS patients at high bleeding risk.
关于急性冠状动脉综合征（ACS）日本患者出血事件的数据不足。此外，高出血风险患者使用普拉格雷 2.5mg/日维持剂量的疗效和安全性尚不清楚。
我们前瞻性纳入了 1167 例疑似 ACS 并接受经皮冠状动脉介入治疗的连续患者。对于体重较轻（≤50kg）、年龄较大（≥75 岁）或肾功能不全（eGFR≤30mL/min/1.73m）的患者，处方普拉格雷 2.5mg/日维持剂量。992 例接受药物洗脱支架治疗的 ACS 患者评估住院期间事件。排除 29 例住院期间死亡患者，963 例 ACS 患者评估院外事件。主要安全性结局指标为主要出血（BARC 类型 3 和 5）。住院期间主要出血的发生率为 3.4%。多变量分析显示，年龄较大、体重较轻、肾功能不全、卒中史、股动脉入路和机械支持使用是住院期间主要出血的独立预测因素。普拉格雷 2.5mg/日（n=284）和 3.75mg/日（n=487）组 1 年累计院外主要出血发生率无显著差异（1.6% vs. 0.7%，对数秩 P=0.24）。两组的院外明确或可能支架血栓形成发生率均为 0%。
调整后的普拉格雷 2.5mg/日维持剂量似乎是高出血风险 ACS 患者的一种选择。
