Mori Hiroyoshi, Mizukami Takuya, Maeda Atsuo, Fukui Kazuki, Akashi Yoshihiro, Ako Junya, Ikari Yuji, Ebina Toshiaki, Tamura Kouichi, Namiki Atsuo, Michishita Ichiro, Kimura Kazuo, Suzuki Hiroshi
Department of Cardiology, Showa University Fujigaoka Hospital, Yokohama 227-8501, Japan.
Kanagawa Cardiovascular and Respiratory Center, Department of Cardiology, Yokohama 236-0051, Japan.
J Clin Med. 2022 Apr 4;11(7):2016. doi: 10.3390/jcm11072016.
Dual antiplatelet therapy (DAPT) with aspirin plus P2Y12 inhibitor is used as a standard therapy for patients with acute myocardial infarction (AMI) treated with drug-eluting stents (DESs). In Japan, clopidogrel was the major P2Y12 inhibitor used for a decade until the new P2Y12 inhibitor, prasugrel, was introduced. Based on clinical studies considering Japanese features, the set dose for prasugrel was reduced to 20 mg as a loading dose (LD) and 3.75 mg as a maintenance dose (MD); these values are 60 and 10 mg, respectively, globally. Despite this dose discrepancy, little real-world clinical data regarding its efficacy and safety exist.
From the K-ACTIVE registry, based on the DAPT regimen, patients were divided into a prasugrel group and a clopidogrel group. The ischemic event was a composite of cardiovascular death, non-fatal MI, and non-fatal stroke. The bleeding event was type 3 or 5 bleeding based on the Bleeding Academic Research Consortium (BARC) criteria.
Substantially more patients were prescribed prasugrel ( = 2786) than clopidogrel ( = 890). Clopidogrel tended to be selected over prasugrel in older patients with numerous comorbidities. Before adjustments were made, the cumulative incidence of ischemic events at 1 year was significantly greater in the clopidogrel group than in the prasugrel group ( = 0.007), while the cumulative incidence of bleeding events at 1 year was comparable between the groups ( = 0.131). After adjustments were made for the age, sex, body weight, creatine level, type of AMI, history of MI, approach site, oral anticoagulation therapy, presence of multivessel disease, Killip classification, and presence of intra-aortic balloon pumping, both ischemic and bleeding events became comparable between the groups.
A Japanese dose of prasugrel was commonly used in AMI patients in the real-world database. Both the prasugrel and clopidogrel groups showed comparable rates of 1 year ischemic and bleeding events.
阿司匹林联合P2Y12抑制剂的双重抗血小板治疗（DAPT）被用作接受药物洗脱支架（DES）治疗的急性心肌梗死（AMI）患者的标准治疗方法。在日本，在新型P2Y12抑制剂普拉格雷引入之前的十年间，氯吡格雷是主要使用的P2Y12抑制剂。基于考虑日本人群特征的临床研究，普拉格雷的设定剂量减至负荷剂量（LD）20mg和维持剂量（MD）3.75mg；而在全球范围内，这些数值分别为60mg和10mg。尽管存在这种剂量差异，但关于其疗效和安全性的真实世界临床数据却很少。
从K-ACTIVE注册研究中，根据DAPT治疗方案，将患者分为普拉格雷组和氯吡格雷组。缺血事件是心血管死亡、非致命性心肌梗死和非致命性卒中的复合事件。出血事件根据出血学术研究联盟（BARC）标准为3型或5型出血。
使用普拉格雷的患者（n = 2786）明显多于使用氯吡格雷的患者（n = 890）。在患有多种合并症的老年患者中，氯吡格雷的选用倾向高于普拉格雷。在进行调整之前，氯吡格雷组1年时缺血事件的累积发生率显著高于普拉格雷组（P = 0.007），而两组1年时出血事件的累积发生率相当（P = 0.131）。在对年龄、性别、体重、肌酐水平、AMI类型、心肌梗死病史、手术部位、口服抗凝治疗、多支血管病变的存在、Killip分级以及主动脉内球囊泵的使用情况进行调整后，两组间的缺血和出血事件发生率变得相当。
在真实世界数据库中，日本剂量的普拉格雷常用于AMI患者。普拉格雷组和氯吡格雷组1年时的缺血和出血事件发生率相当。
