Indobufen-based dual antiplatelet therapy in patients with multivessel coronary disease undergoing drug-eluting stent implantation insight from the OPTION trial

IF 3.7 2区医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS American heart journal Pub Date : 2024-12-20 DOI:10.1016/j.ahj.2024.12.007

Lili Xu MD , Huajie Xu MD , Shujing Wu MD , Huanyi Zhang MB , Kang Cheng MD , Xiaoyan Wang MD , Manhua Chen MB , Guangping Li MD , Jiangnan Huang MD , Jun Lan MM , Guanghe Wei MM , Xin Zhao MD , Zhiyong Qi MD , Juying Qian MD , Hongyi Wu MD , Junbo Ge MD

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Abstract

Background

It remains unclear whether indobufen-based dual antiplatelet therapy (DAPT) preserves ischemic protection while limiting bleeding risk in patients with multivessel coronary disease (MVD). This study aimed to investigate the efficacy and safety of indobufen-based DAPT in patients with MVD.

Methods

Patients in the OPTION trial were stratified based on the presence of MVD. We compared the ischemic and bleeding risks of indobufen-based DAPT (indobufen 100mg twice a day plus clopidogrel 75 mg/d for 12 months) vs conventional DAPT (aspirin 100 mg/d plus clopidogrel 75 mg/d for 12 months) in patients with and without MVD, using landmarks at 6 months and 1-year post-percutaneous coronary intervention (PCI).

Results

Patients with MVD tended to be older and contained a higher prevalence of high-risk features. Compared with patients without MVD, those with MVD were at higher risk for net adverse clinical events and ischemic events. The risk of ischemic events between indobufen-based DAPT vs conventional DAPT was similar either in patients with MVD or without MVD during the first and second 6 months. During the first 6 months, indobufen-based DAPT decreased the risk of bleeding events consistently in patients with and without MVD. Of note, during the second 6 months, indobufen-based DAPT continually decreased the risk of bleeding events in patients with MVD but not in those without MVD.

Conclusions

In patients with MVD, indobufen plus clopidogrel DAPT compared to aspirin plus clopidogrel DAPT could reduce the risk of bleeding events while preserving ischemic protection during both the first and second 6 months post-PCI. Indobufen presents an effective option for patients with MVD, especially those at high ischemic risk requiring DAPT beyond 6 months post-PCI.

Trial registration

The trial was registered at www.chictr.org. A Randomized Controlled Trial of Indobufen vs Aspirin after Coronary Drug-eluting Stent Implantation: the OPTION Trial (ChiCTR-IIR-17013505).

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基于吲哚布芬的双重抗血小板治疗在接受药物洗脱支架植入术的多支冠状动脉疾病患者中的应用

背景：目前尚不清楚以吲哚布芬为基础的双重抗血小板治疗（DAPT）是否在限制多支冠状动脉疾病（MVD）患者出血风险的同时保留了缺血保护。本研究旨在探讨以吲哚布芬为基础的DAPT治疗MVD患者的有效性和安全性。方法：OPTION试验中的患者根据MVD的存在进行分层。我们使用经皮冠状动脉介入治疗（PCI）后6个月和1年的标志，比较了有和没有MVD的患者中，基于吲哚布芬的DAPT（吲哚布芬100mg/d，每天两次，加氯吡格雷75mg/d，持续12个月）与传统DAPT（阿司匹林100mg/d，加氯吡格雷75mg/d，持续12个月）的缺血性和出血风险。结果：MVD患者年龄偏大，具有较高的高危特征。与没有MVD的患者相比，MVD患者发生净不良临床事件和缺血性事件的风险更高。在前6个月和后6个月，有MVD或无MVD的患者中，基于吲哚布芬的DAPT与常规DAPT的缺血性事件风险相似。在前6个月，以吲哚布芬为基础的DAPT在有和没有MVD的患者中持续降低出血事件的风险。值得注意的是，在第二个6个月期间，以吲哚布芬为基础的DAPT持续降低MVD患者出血事件的风险，但在没有MVD的患者中没有。结论：在MVD患者中，与阿司匹林加氯吡格雷DAPT相比，吲哚布芬加氯吡格雷DAPT可以降低出血事件的风险，同时在pci术后的前6个月和后6个月保持缺血保护。Indobufen是MVD患者的有效选择，特别是那些pci术后6个月后需要DAPT的高缺血风险患者。试验注册：试验注册在www.chictr.org。冠脉药物洗脱支架植入术后茚布芬与阿司匹林的随机对照试验：OPTION试验（chicr - iir -17013505）

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来源期刊

American heart journal 医学-心血管系统

CiteScore

8.20

自引率

2.10%

发文量

214

审稿时长

38 days

期刊介绍： The American Heart Journal will consider for publication suitable articles on topics pertaining to the broad discipline of cardiovascular disease. Our goal is to provide the reader primary investigation, scholarly review, and opinion concerning the practice of cardiovascular medicine. We especially encourage submission of 3 types of reports that are not frequently seen in cardiovascular journals: negative clinical studies, reports on study designs, and studies involving the organization of medical care. The Journal does not accept individual case reports or original articles involving bench laboratory or animal research.