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Patients with diabetes face a heightened risk of ischemic events after coronary stenting, yet the optimal antiplatelet strategy for secondary prevention remains debated. A post hoc analysis of the OPTION trial, published in the  Journal of Diabetes, evaluated the efficacy and safety of indobufen-based dual antiplatelet therapy (DAPT) compared with aspirin-based DAPT in patients with diabetes after coronary stenting with drug-eluting stents (DES). OPTION was a randomized, open-label, noninferiority, trial conducted across multiple centers in China, with patients randomized 1:1 to indobufen-based or aspirin-based DAPT.

Among 4551 patients, the 1-year primary composite endpoint—cardiovascular death, nonfatal myocardial infarction, ischemic stroke, definite or probable stent thrombosis, or BARC type 2, 3, or 5 bleeding—occurred in 93 of /1570 patients with diabetes (5.92%) and 148 of /2981 without diabetes (4.96%). Hazard ratios were similar for patients with diabetes (HR 0.72, 95% CI 0.47–1.08) and without diabetes (HR 0.73, 95% CI 0.53–1.01), with no significant interaction (Pinteraction = 0.935). 

Secondary efficacy and safety outcomes were also consistent between subgroups. Notably, safety outcomes showed favorable hazard ratios for indobufen in both diabetes (HR 0.56, 95% CI 0.34–0.92) and non-diabetes groups (HR 0.66, 95% CI 0.45–0.98).

The findings suggest that indobufen-based DAPT may represent a reasonable alternative to aspirin-based therapy for secondary prevention in patients with diabetes after DES implantation, particularly for those at high bleeding risk.

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Key highlights
  • Post hoc analysis of the OPTION trial compared indobufen- and aspirin-based DAPT in 4551 patients after DES implantation.
  • At 1 year, the primary composite endpoint occurred in 5.92% of patients with diabetes and 4.96% without diabetes, with no significant difference.
  • Efficacy outcomes were consistent across subgroups, while safety results favored indobufen.
  • Indobufen-based DAPT may be a safe alternative for secondary prevention, especially in patients at high bleeding risk.
Source

Wu S, Xu H, Xu L, et al. Indobufen Versus Aspirin Plus Clopidogrel in Patients After Coronary Stenting in Patients With Diabetes: A Post Hoc Analysis of the OPTION Trial. J Diabetes. 2025;17(9):e70152. doi:10.1111/1753-0407.70152

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Indobufen-Based DAPT Shows Comparable Safety to Aspirin-Based DAPT
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Indobufen may serve as a safe alternative to aspirin for secondary prevention in patients with diabetes undergoing DES implantation.

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