Department of Cardiovascular Medicine, Chiba University Graduate School of Medicine, Chiba, Japan.
Biostatistics Section, Clinical Research Center, Chiba University Hospital, Chiba, Japan.
PLoS One. 2022 Jul 28;17(7):e0272140. doi: 10.1371/journal.pone.0272140. eCollection 2022.
Triple antithrombotic therapy, including dual antiplatelet therapy and oral anticoagulant (OAC), is recommended for a short-term period after percutaneous coronary intervention (PCI) in patients requiring anticoagulation therapy. The purpose of this study was to compare in-hospital clinical outcomes between low-dose prasugrel (3.75 mg/day) and clopidogrel, as part of triple antithrombotic therapy, using a large database in Japan.
Patients with ischemic heart disease who underwent PCI between January 2015 and December 2019, and were prescribed triple therapy with aspirin, a P2Y12 inhibitor (clopidogrel or low-dose prasugrel), and OAC (direct oral anticoagulant: DOAC or vitamin K antagonist: VKA), were selected from the Diagnosis Procedure Combination database. The primary outcome was in-hospital mortality. The secondary outcomes were myocardial infarction, ischemic stroke, bleeding stroke, gastrointestinal bleeding, and blood transfusion.
Overall, 5,777 patients were eligible in this analysis. The patients were divided into 4 subgroups according to the type of P2Y12 inhibitor and OAC: clopidogrel/DOAC (n = 1,628), clopidogrel/VKA (n = 1,334), prasugrel/DOAC (n = 1,607), and prasugrel/VKA (n = 1,208). There was no significant difference in the incidence of death and gastrointestinal bleeding among the 4 subgroups. The prasugrel/DOAC group had significantly lower incidence of MI (OR 0.566, 95% CI 0.348-0.921). The incidence of ischemic stroke was significantly lower in the prasugrel/DOAC group (OR 0.701, 95% CI 0.502-0.979), and significantly higher in the clopidogrel/VKA group (OR 1.680, 95% CI 1.273-2.216). Need for blood transfusion was less frequent in the prasugrel/DOAC group (OR 0.729, 95% CI 0.598-0.890), and more frequent in both the clopidogrel/VKA group (OR 1.424, 95% CI 1.187-1.708) and the prasugrel/VKA group (OR 1.633, 95% CI 1.367-1.950).
Combination of low-dose prasugrel and DOAC was associated with lower incidence of MI, ischemic stroke, and blood transfusion. Low-dose prasugrel may be feasible as part of triple therapy in patients undergoing PCI.
对于需要抗凝治疗的经皮冠状动脉介入治疗(PCI)后的患者,推荐进行包括双联抗血小板治疗和口服抗凝剂(OAC)在内的三联抗血栓治疗。本研究旨在使用日本的一个大型数据库,比较低剂量普拉格雷(3.75mg/天)和氯吡格雷作为三联抗血栓治疗的一部分的住院期间临床结局。
从诊断程序组合数据库中选择 2015 年 1 月至 2019 年 12 月期间接受 PCI 且接受阿司匹林、P2Y12 抑制剂(氯吡格雷或低剂量普拉格雷)和 OAC(直接口服抗凝剂:DOAC 或维生素 K 拮抗剂:VKA)三联治疗的缺血性心脏病患者。主要结局是住院期间死亡率。次要结局是心肌梗死、缺血性卒中和出血性卒中和输血。
总体而言,5777 例患者符合本分析标准。根据 P2Y12 抑制剂和 OAC 的类型,将患者分为 4 个亚组:氯吡格雷/DOAC(n=1628)、氯吡格雷/VKA(n=1334)、普拉格雷/DOAC(n=1607)和普拉格雷/VKA(n=1208)。在 4 个亚组中,死亡率和胃肠道出血发生率没有显著差异。普拉格雷/DOAC 组的心肌梗死发生率明显较低(OR 0.566,95%CI 0.348-0.921)。普拉格雷/DOAC 组缺血性卒中和出血性卒中的发生率明显低于氯吡格雷/VKA 组(OR 0.701,95%CI 0.502-0.979 和 OR 1.680,95%CI 1.273-2.216),而氯吡格雷/VKA 组则明显更高(OR 1.424,95%CI 1.187-1.708 和 OR 1.633,95%CI 1.367-1.950)。普拉格雷/DOAC 组输血需求明显减少(OR 0.729,95%CI 0.598-0.890),氯吡格雷/VKA 组和普拉格雷/VKA 组输血需求明显增加(OR 1.424,95%CI 1.187-1.708 和 OR 1.633,95%CI 1.367-1.950)。
低剂量普拉格雷与 DOAC 联合使用与心肌梗死、缺血性卒中和输血发生率降低相关。低剂量普拉格雷可能是 PCI 后三联抗血栓治疗的可行选择。