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

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.