Summary: In a post-hoc analysis of the OPTION trial, indobufen-based dual antiplatelet therapy after drug-eluting stenting performed consistently in patients with and without diabetes, with no interaction between diabetes status and treatment effect for ischemic outcomes, and a similar safety advantage in both groups.
PICO Summary
| Element | Detail |
|---|---|
| Population | 4551 OPTION patients after drug-eluting stent implantation, 1570 with diabetes; open-label, multicentre, China. |
| Intervention | Indobufen-based dual antiplatelet therapy (reversible COX inhibitor plus a P2Y12 inhibitor). |
| Comparison | Aspirin-based DAPT (aspirin plus clopidogrel); analysed by diabetes status. |
| Outcome | The 1-year composite (ischemic events plus clinically relevant bleeding) was similar across arms in diabetes (HR 0.72) and without (HR 0.73), with no interaction (p=0.935). The safety endpoint favoured indobufen in both diabetes (HR 0.56; 95% CI 0.34–0.92) and non-diabetes (HR 0.66; 95% CI 0.45–0.98), interaction p=0.609. Efficacy endpoints did not differ by diabetes status. |
Indobufen vs aspirin DAPT after stenting (OPTION)
Post-hoc RCT · type 2 diabetes · 1 year
Indobufen-based DAPT behaved consistently regardless of diabetes status, with a similar bleeding-safety advantage in both subgroups. Diabetes did not modify the treatment effect.
Expert Commentary
This is a worthwhile analysis whose message is best stated as consistency rather than a diabetes-specific breakthrough. The appeal of indobufen lies in its reversible inhibition of cyclo-oxygenase, so platelet function recovers within hours rather than the days aspirin demands, which is mechanistically attractive for reducing bleeding without sacrificing ischaemic protection. What this post-hoc analysis actually shows is that the indobufen-based regimen behaved the same in diabetic and non-diabetic patients, with no statistical interaction for the composite or efficacy endpoints and a similar bleeding-related safety advantage in both, so diabetes does not appear to modify the treatment effect. That is reassuring for a high-risk group, but I would resist framing it as a uniquely diabetic benefit. The caveats matter: this is a subgroup analysis of an open-label trial, the comparator was clopidogrel rather than a more potent P2Y12 inhibitor, and indobufen is unavailable in many countries including the United States. Can I use this with my patients? Where indobufen is available, it supports it as a reasonable aspirin alternative after stenting, including in diabetic patients at bleeding risk, while elsewhere the broader lesson is to individualise antiplatelet strategy by ischaemic and bleeding risk.
References
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