A comparison of the safety and effectiveness of prasugrel and clopidogrel in younger population undergoing percutaneous coronary intervention: A retrospective study using a Japanese claims database
A comparison of the safety and effectiveness of prasugrel and clopidogrel in younger population undergoing percutaneous coronary intervention: A retrospective study using a Japanese claims database
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DOI：
10.1016/j.jjcc.2020.10.001
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发表时间：
2021-02-01
影响因子：
2.5
通讯作者：
Ohte, Nobuyuki
中科院分区：
文献类型：
--
作者：
Hagiwara, Hiromi;Fukuta, Hidekatsu;Ohte, Nobuyuki
背景：普拉格雷比氯吡格雷更有效地抑制血小板聚集。在全球III期试验中，普拉格雷[负荷剂量/维持剂量（LD/MD），60/10 mg]降低了计划接受经皮冠状动脉介入治疗（PCI）的急性冠状动脉综合征患者缺血事件的发生率，但与氯吡格雷相比，其出血风险更高。在一项针对相似患者的日本III期试验中，调整了普拉格雷剂量方案（LD/MD，20/3.75 mg），普拉格雷和氯吡格雷的疗效与全球试验相当;但是，由于把握度有限，无法确定安全性。鉴于严格的入组标准，日本III期试验的结果可能不适用于常规临床实践。我们比较了普拉格雷和氯吡格雷在日本患者中的安全性和有效性。方法：通过分析日本上市后阶段准备的大型索赔数据库，我们确定了接受PCI的患者，并比较了接受普拉格雷和接受氯吡格雷的患者之间出血和缺血性冠状动脉事件的发生率。结果：在2014年1月1日至2018年12月31日期间，我们确定了1977例计划接受紧急PCI的患者（紧急PCI队列）和1922例计划接受择期PCI的患者（择期PCI队列）。倾向评分匹配后，紧急（n = 1080）和择期PCI（n = 1626）队列中普拉格雷和氯吡格雷组的基线临床特征无显著差异。在考克斯比例风险分析中，出血或缺血性冠状动脉事件的发生率在中位数8个月的后续在两个cohols.Conclusions：普拉格雷的安全性和有效性是可比的氯吡格雷在真实的世界日本患者计划接受PCI。(c)2020年日本心脏病学院。由爱思唯尔有限公司发布。保留所有权利。
Background: Prasugrel inhibits platelet aggregation more potently than clopidogrel. In the global phase III trial, prasugrel [loading dose/maintenance dose (LD/MD), 60/10 mg] reduced the incidence of ischemic events but involved a higher risk of hemorrhage than clopidogrel in patients with acute coronary syndromes who were scheduled to undergo percutaneous coronary intervention (PCI). In the Japanese phase III trial for similar patients wherein the prasugrel dose regimen was adjusted (LD/MD, 20/3.75 mg), the efficacy of prasugrel and clopidogrel were comparable to that in the global trial; however, the safety could not be determined due to limited power. Given the strict enrollment criteria, the results of the Japanese phase III trial may not be applicable to routine clinical practice. We compared the safety and effectiveness of prasugrel and clopidogrel in the real-world setting in Japanese patients.Methods: With an analysis of a large claims database prepared during the post-marketing stages in Japan, we identified patients undergoing PCI and compared the incidence of bleeding and ischemic coronary events between patients who received prasugrel and those receiving clopidogrel.Results: Between January 1, 2014 and December 31, 2018, we identified 1977 patients who were scheduled to undergo urgent PCI (urgent PCI cohort) and 1922 who were scheduled to undergo elective PCI (elective PCI cohort). After propensity-score matching, there were no significant differences in the baseline clinical characteristics of the prasugrel and clopidogrel groups in the urgent (n = 1080) and elective PCI (n = 1626) cohorts. In Cox proportional hazard analyses, there were no significant differences in the incidence of bleeding or ischemic coronary events during the median 8-month follow-up in both cohorts.Conclusions: The safety and effectiveness of prasugrel was comparable to that of clopidogrel in real world Japanese patients scheduled to undergo PCI. (c) 2020 Japanese College of Cardiology. Published by Elsevier Ltd. All rights reserved.