背景:调整剂量和标准剂量普拉格雷在接受经皮冠状动脉介入治疗(PCI)的东亚急性心肌梗死(AMI)患者中的相对疗效和安全性尚不清楚。这项研究旨在比较评估调整剂量(维持剂量:3.75mg)和标准剂量(维持剂量:10mg)普拉格雷在接受PCI的东亚AMI患者中的缺血和出血结局。
方法:来自日本和韩国全国AMI注册中心的合并数据集(n=17,118),我们确定了接受调整剂量或标准剂量普拉格雷治疗的患者.未接受急诊PCI的患者,口服抗凝剂的患者,以及符合韩国普拉格雷禁忌症标准的人群(年龄≥75岁,体重<60公斤,或中风史)被排除。比较调整剂量(n=1160)和标准剂量(n=1086)普拉格雷组的主要不良心血管事件(MACE)和心肌梗死溶栓(TIMI)主要出血事件。
结果:在倾向匹配队列中(每组n=702),在调整剂量和标准剂量普拉格雷组之间的住院MACE中没有观察到显着差异(1.85%vs.2.71%,优势比[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院内大出血发生率显着低于标准剂量组(0.43%vs.1.71%,OR0.25,95%CI0.07-0.88,p=0.031)。两组12个月MACE的累积发生率相当(4.70%vs.4.70%,或1.00,95%CI0.61-1.64,p=1.000)。
结论:在接受PCI的东亚AMI患者中,与接受标准剂量普拉格雷的患者相比,接受调整剂量普拉格雷的患者发生院内出血事件的风险较低,同时保持相当的1年MACE发生率。
BACKGROUND: 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.
METHODS: 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.
RESULTS: 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).
CONCLUSIONS: 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.