Department of Cardiovascular Medicine, National Cerebral and Cardiovascular Center, Osaka, Japan.
Department of Cardiology, Chung-Ang University Hospital, Seoul, South Korea.
Int J Cardiol. 2024 Sep 1;410:132197. doi: 10.1016/j.ijcard.2024.132197. Epub 2024 May 31.
The comparative efficacy and safety of adjusted- and standard-dose prasugrel in East Asian patients with acute myocardial infarction (AMI) undergoing percutaneous coronary intervention (PCI) remain unclear. This study aimed to comparatively assess the ischaemic and bleeding outcomes of adjusted-dose (maintenance dose: 3.75 mg) and standard-dose (maintenance dose: 10 mg) prasugrel in East Asian patients with AMI undergoing PCI.
From a combined dataset sourced from nationwide AMI registries in Japan and South Korea (n = 17,118), patients treated with either adjusted- or standard-dose prasugrel were identified. Patients who did not undergo emergent PCI, those on oral anticoagulants, and those meeting the criteria of contraindication of prasugrel in South Korea (age ≥ 75 years, body weight < 60 kg, or history of stroke) were excluded. Major adverse cardiovascular events (MACE) and Thrombolysis in Myocardial Infarction (TIMI) major bleeding events were compared between the adjusted-dose (n = 1160) and standard-dose (n = 1086) prasugrel groups.
Within the propensity-matched cohort (n = 702 in each group), no significant difference was observed in the in-hospital MACE between the adjusted- and standard-dose prasugrel groups (1.85% vs. 2.71%, odds ratio [OR] 0.68, 95% confidence interval [CI] 0.33-1.38, p = 0.286). However, the incidence of in-hospital major bleeding was significantly lower in the adjusted-dose prasugrel group than in the standard-dose group (0.43% vs. 1.71%, OR 0.25, 95% CI 0.07-0.88, p = 0.031). The cumulative 12-month incidence of MACE was equivalent in both groups (4.70% vs. 4.70%, OR 1.00, 95% CI 0.61-1.64, p = 1.000).
Among East Asian patients with AMI undergoing PCI, those administered adjusted-dose prasugrel exhibited a lower risk of in-hospital bleeding events than those administered standard-dose prasugrel, while maintaining a comparable 1-year incidence of MACE.
调整剂量和标准剂量普拉格雷在东亚经皮冠状动脉介入治疗（PCI）的急性心肌梗死（AMI）患者中的疗效和安全性比较尚不清楚。本研究旨在比较东亚 AMI 患者 PCI 中调整剂量（维持剂量：3.75mg）和标准剂量（维持剂量：10mg）普拉格雷的缺血和出血结局。
从日本和韩国全国性 AMI 注册中心的合并数据集（n=17118）中，确定了接受调整剂量或标准剂量普拉格雷治疗的患者。未行紧急 PCI、口服抗凝剂、或符合韩国普拉格雷禁忌标准（年龄≥75 岁、体重<60kg 或中风史）的患者被排除在外。主要不良心血管事件（MACE）和血栓形成溶栓（TIMI）大出血事件在调整剂量（n=1160）和标准剂量（n=1086）普拉格雷组之间进行比较。
在倾向匹配队列（每组 n=702）中，调整剂量和标准剂量普拉格雷组的住院期间 MACE 无显著差异（1.85% vs. 2.71%，比值比[OR]0.68，95%置信区间[CI]0.33-1.38，p=0.286）。然而，调整剂量普拉格雷组的住院期间大出血发生率显著低于标准剂量组（0.43% vs. 1.71%，OR0.25，95%CI0.07-0.88，p=0.031）。两组 12 个月的 MACE 累积发生率相当（4.70% vs. 4.70%，OR1.00，95%CI0.61-1.64，p=1.000）。
在东亚 AMI 行 PCI 的患者中，与标准剂量普拉格雷相比，调整剂量普拉格雷可降低住院期间出血事件的风险，同时保持 1 年 MACE 发生率相当。
