Indobufen Versus Aspirin Plus Clopidogrel in Patients After Coronary Stenting in Patients With Diabetes: A Post Hoc Analysis of the OPTION Trial
Year: 2025
Type: article
Abstract: ABSTRACT Background Despite increased risk of ischemic events in diabetes, the optimal anti‐thrombotic strategy for secondary prevention has not been defined. We aimed to assess the efficacy and safety of optimal antiplatelet agents such as indobufen‐based dual antiplatelet therapy (DAPT) in patients with diabetes after coronary stenting. Methods OPTION trial was a randomized, open‐label, noninferiority, and multicentric study in China. Enrolled subjects were randomized 1:1 to indobufen‐based DAPT or aspirin‐based DAPT. This post hoc analysis from OPTION trial was performed by the presence of diabetes. The primary endpoint was a 1‐year composite of cardiovascular death, nonfatal myocardial infarction, ischemic stroke, definite or probable stent thrombosis, or Bleeding Academic Research Consortium (BARC) criteria type 2, 3, or 5 bleeding. Results Of 4551 OPTION patients, the primary endpoint occurred in 93/1570 patients with diabetes (5.92%), as compared to 148/2981 without diabetes (4.96%) (HR: 0.72, 95% CI: 0.47–1.08, and HR: 0.73, 95% CI: 0.53–1.01, respectively), without significant interaction between diabetes status and treatment effect (Pinteraction = 0.935). The secondary efficacy endpoint was comparable between patients with (HR: 1.31, 95% CI: 0.60–2.84) and without diabetes (HR: 0.95, 95% CI: 0.51–1.76) (Pinteraction = 0.526). Similarly, both subgroups derived similar benefits for the safety endpoint (HR, 0.56; 95% CI, 0.34–0.92 for subjects with diabetes vs. HR, 0.66; 95% CI, 0.45–0.98 for those without diabetes; Pinteraction = 0.609). Conclusions In patients receiving DES implantation, indobufen‐based DAPT might be considered as a reasonable alternative to aspirin‐based DAPT in the secondary prevention for those with diabetes, especially in patients at high bleeding risk.
Source: Journal of Diabetes
Authors: Shujing Wu, Huajie Xu, Lili Xu, Huanyi Zhang, Kang Cheng, Xiaoyan Wang, Manhua Chen, Guangping Li, Jiangnan Huang, Jun Lan, Guanghe Wei, Xin Zhao, Zhiyong Qi, Juying Qian, Hongyi Wu, Junbo Ge, the OPTION investigators
Institutions: Fudan University, Zhongshan Hospital, Taian City Central Hospital, Northwest University, Wuxi Fourth People's Hospital, Central Hospital of Wuhan, Second Hospital of Tianjin Medical University, Guangxi Medical University, First Affiliated Hospital of GuangXi Medical University, Affiliated Hospital of Jining Medical University
Language: English
Subfield: Cardiology and Cardiovascular Medicine
Field: Medicine
Domain: Health Sciences
Open Access status: gold
Estimated APC paid: $3,000
OpenAlex ID: W4414023458