Indobufen Versus Aspirin Plus Clopidogrel in Patients After Coronary Stenting in Patients With Diabetes: A Post Hoc Analysis of the OPTION Trial

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 (P_interaction = 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) (P_interaction = 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; P_interaction = 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.