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日本慢性冠状动脉综合征患者经皮冠状动脉介入治疗后使用生物可降解聚合物铂铬依维莫司洗脱支架行普拉格雷单药治疗(ASET-JAPAN)。

Prasugrel Monotherapy After Percutaneous Coronary Intervention With Biodegradable-Polymer Platinum-Chromium Everolimus Eluting Stent for Japanese Patients With Chronic Coronary Syndrome (ASET-JAPAN).

机构信息

Department of Cardiology, Fujita Health University Hospital.

Cardiovascular Research Centre for Advanced Imaging and Core Laboratory (CORRIB), University of Galway.

出版信息

Circ J. 2023 May 25;87(6):857-865. doi: 10.1253/circj.CJ-23-0051. Epub 2023 Mar 11.

DOI:10.1253/circj.CJ-23-0051
PMID:36908118
Abstract

BACKGROUND

P2Y12 inhibitor monotherapy without aspirin immediately after percutaneous coronary intervention (PCI) has not been tested in East Asian patients, so in this study we aimed to assess the safety and feasibility of reduced dose (3.75 mg/day) prasugrel monotherapy in Japanese patients presenting with chronic coronary syndrome (CCS).

METHODS AND RESULTS

ASET-JAPAN is a prospective, multicenter, single-arm pilot study that completed enrolment of 206 patients from 12 Japanese centers in September 2022. Patients with native de-novo coronary lesions and a SYNTAX score <23 were treated exclusively with biodegradable-polymer platinum-chromium everolimus-eluting stent(s). Patients were loaded with standard dual antiplatelet therapy (DAPT) and following successful PCI and optimal stent deployment, they received low-dose prasugrel (3.75 mg/day) monotherapy for 3 months. The primary ischemic endpoint was a composite of cardiac death, spontaneous target-vessel myocardial infarction, or definite stent thrombosis. The primary bleeding endpoint was Bleeding Academic Research Consortium (BARC) type 3 or 5. At 3-month follow-up, there were no primary bleeding or ischemic events, or any stent thrombosis.

CONCLUSIONS

This pilot study showed the safety and feasibility of prasugrel monotherapy in selected low-risk Japanese patients with CCS. This "aspirin-free" strategy may be a safe alternative to traditional DAPT following PCI.

摘要

背景

在东亚患者中,经皮冠状动脉介入治疗(PCI)后不联合使用阿司匹林的 P2Y12 抑制剂单药治疗尚未得到检验,因此本研究旨在评估在患有慢性冠状动脉综合征(CCS)的日本患者中使用低剂量(3.75mg/天)普拉格雷单药治疗的安全性和可行性。

方法和结果

ASET-JAPAN 是一项前瞻性、多中心、单臂的初步研究,于 2022 年 9 月在日本的 12 个中心完成了 206 例患者的入组。患者的病变为初发的、非阻塞性冠状动脉病变,且 SYNTAX 评分<23,接受了可生物降解聚合物载铂-铬依维莫司洗脱支架(s)的治疗。患者接受标准双联抗血小板治疗(DAPT),在成功进行 PCI 和最佳支架扩张后,他们接受低剂量普拉格雷(3.75mg/天)单药治疗 3 个月。主要缺血终点是心脏死亡、自发性靶血管心肌梗死或明确的支架血栓形成的复合终点。主要出血终点是出血学术研究联合会(BARC)3 型或 5 型。在 3 个月随访时,没有发生主要出血或缺血事件,也没有发生任何支架血栓形成。

结论

这项初步研究表明,在患有 CCS 的日本低危患者中,普拉格雷单药治疗是安全可行的。这种“无阿司匹林”策略可能是 PCI 后传统 DAPT 的一种安全替代方案。

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