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比较低剂量普拉格雷和氯吡格雷作为需要口服抗凝治疗和经皮冠状动脉介入治疗的三联抗栓治疗一部分的短期临床结局。

Comparison of short-term clinical outcomes between low-dose prasugrel and clopidogrel as part of triple antithrombotic therapy in patients requiring oral anticoagulant therapy and percutaneous coronary intervention.

机构信息

Department of Cardiovascular Medicine, Chiba University Graduate School of Medicine, Chiba, Japan.

Biostatistics Section, Clinical Research Center, Chiba University Hospital, Chiba, Japan.

出版信息

PLoS One. 2022 Jul 28;17(7):e0272140. doi: 10.1371/journal.pone.0272140. eCollection 2022.

Abstract

BACKGROUND

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.

METHODS

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.

RESULTS

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).

CONCLUSIONS

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.

摘要

背景

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。

方法

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。

结果

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)。

结论

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。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/444d/9333269/d03de727ee69/pone.0272140.g001.jpg

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