OPTION –Indobufen is Noninferior to Aspirin After Coronary Drug-Eluting Stent Implantation

By Leah Kosyakovsky on

Key Points:

  • Indobufen, a platelet aggregation inhibitor, has been shown to be a shorter acting antiplatelet in comparison to aspirin. However, it has not been studied as a component of DAPT in patients requiring stent implantation.
  • In the OPTION study, patients with CAD undergoing stent placement were randomized to either indobufen or aspirin. The primary outcome of interest was a 1-year composite of CV death, nonfatal MI, ischemic stroke, definite or probable stent thrombosis, or BARC type-2, 3, or 5 bleeding
  • Indobufen was found to be non-inferior to aspirin in the primary endpoint.

In animal models, the platelet aggregation inhibitor indobufen has been shows to inhibit coagulation with a shorter duration of antiplatelet efficacy than aspirin, enabling complete platelet function recovery at 24 hours. However, indobufen has never been studied as an aspirin alternative in patients with coronary artery disease requiring DAPT after stent placement.  In a breaking presentation at the 2022 AHA Scientific Sessions today, Dr. Junbo Ge (Chinese Academy of Sciences) and his team presented their study: “Efficacy and Safety of Indobufen versus Aspirin After Coronary Drug-Eluting Stent Implantation: A Randomized, Open-Label, Non-Inferiority Trial,” or the OPTION trial.

The OPTION study (NCT05105750) was a single-center randomized non-inferiority clinical trial conducted in Nanjing, China which evaluated the effects of aspirin 100mg daily versus indobufen 200mg BID in patients with coronary atherosclerosis with an indication or stent placement (in additional to clopidogrel therapy). The inclusion criteria comprised any adults with CAD; relevant exclusions included indobufen or aspirin contraindication or high bleeding risk. A total of 4,551 patients were randomized. The mean age was 61, and 35% of patients were female; 44% had stable angina, and 56% had unstable angina at randomization.

The primary outcome was a 1-year composite of CV death, nonfatal MI, ischemic stroke, definite or probable stent thrombosis, or BARC type-2, 3, or 5 bleeding; indobufen was non-inferior to aspirin in this primary outcome (HR 0.73, 95% CI 0.56-0.94; p=0.15). The secondary efficacy endpoint of CV death, nonfatal MI, ischemic stroke, and definite or probable stent thrombosis was not significantly different between the two groups. The secondary safety endpoint of BARC type 2,3, or 5 bleeding  was reduced in the indobufen group (HR 0.63, 95% CI 0.46-0.85; p=0.002), which likely drove the overall composite result. There were no differences in any of the prespecified subgroups of age, sex, smoking status, or presence of diabetes, hypertension, renal disease, or multivessel disease.

When discussing the clinical implications of the study at AHA, Dr. Ge stated: “There is no statistical difference in the 1-year composite endpoint between indobufen plus clopidogrel DAPT and conventional DAPT after PCI.”