Xu Lili, Xu Huajie, Wu Shujing, Zhang Huanyi, Cheng Kang, Wang Xiaoyan, Chen Manhua, Li Guangping, Huang Jiangnan, Lan Jun, Wei Guanghe, Zhao Xin, Qi Zhiyong, Qian Juying, Wu Hongyi, Ge Junbo
Department of Cardiology, Zhongshan Hospital, Shanghai Institute of Cardiovascular Diseases, National Clinical Research Center for Interventional Medicine, Fudan University, Shanghai, China; Department of Cardiology, Shanghai Geriatric Medical Center, Shanghai, China.
Department of Infectious Diseases, Zhongshan Hospital, Fudan University, Shanghai, China.
Am Heart J. 2025 Apr;282:21-29. doi: 10.1016/j.ahj.2024.12.007. Epub 2024 Dec 20.
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.
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).
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.
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.
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).
基于吲哚布芬的双联抗血小板治疗（DAPT）在多支冠状动脉疾病（MVD）患者中是否能在限制出血风险的同时保持缺血保护作用仍不清楚。本研究旨在调查基于吲哚布芬的DAPT在MVD患者中的疗效和安全性。
OPTION试验中的患者根据是否存在MVD进行分层。我们比较了基于吲哚布芬的DAPT（吲哚布芬100mg，每日两次，加氯吡格雷75mg/d，共12个月）与传统DAPT（阿司匹林100mg/d加氯吡格雷75mg/d，共12个月）在有或无MVD的患者中的缺血和出血风险，采用经皮冠状动脉介入治疗（PCI）后6个月和1年的时间节点。
MVD患者往往年龄较大，且高危特征的患病率较高。与无MVD的患者相比，有MVD的患者发生净不良临床事件和缺血事件的风险更高。在第一个6个月和第二个6个月期间，基于吲哚布芬的DAPT与传统DAPT相比，有或无MVD的患者发生缺血事件风险相似。在第一个6个月期间，基于吲哚布芬的DAPT在有或无MVD的患者中均持续降低出血事件风险。值得注意的是，在第二个6个月期间，基于吲哚布芬的DAPT持续降低MVD患者的出血事件风险，但对无MVD的患者则无此作用。
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在PCI术后的第一个和第二个6个月期间均可降低出血事件风险，同时保持缺血保护作用。吲哚布芬为MVD患者，尤其是那些在PCI术后6个月以上需要DAPT且缺血风险高的患者提供了一种有效的选择。
该试验在www.chictr.org注册。冠状动脉药物洗脱支架植入术后吲哚布芬与阿司匹林的随机对照试验：OPTION试验（ChiCTR-IIR-17013505）
