Indobufen-based Dual Antiplatelet Therapy in Patients with Multivessel Coronary Disease Undergoing Drug-eluting Stent Implantation Insight From the OPTION Trial

Am Heart J. 2024 Dec 20:S0002-8703(24)00335-1. doi: 10.1016/j.ahj.2024.12.007. Online ahead of print.

Abstract

Background: It remains unclear whether indobufen-based dual antiplatelet therapy (DAPT) preserves ischemic protection while limiting bleeding risk in patients with multivessel coronary disease (MVD). This study aimed to investigate the efficacy and safety of indobufen-based DAPT in patients with MVD.

Methods: Patients in the OPTION trial were stratified based on the presence of MVD. We compared the ischemic and bleeding risks of indobufen-based DAPT (indobufen 100mg twice a day plus clopidogrel 75mg/d for 12 months) versus conventional DAPT (aspirin 100mg/d plus clopidogrel 75mg/d for 12 months) in patients with and without MVD, using landmarks at 6 months and 1 year post-percutaneous coronary intervention (PCI).

Results: Patients with MVD tended to be older and contained a higher prevalence of high-risk features. Compared with patients without MVD, those with MVD were at higher risk for net adverse clinical events and ischemic events. The risk of ischemic events between indobufen-based DAPT versus conventional DAPT was similar either in patients with MVD or without MVD during the first and second 6 months. During the first 6 months, indobufen-based DAPT decreased the risk of bleeding events consistently in patients with and without MVD. Of note, during the second 6 months, indobufen-based DAPT continually decreased the risk of bleeding events in patients with MVD but not in those without MVD.

Conclusions: In patients with MVD, indobufen plus clopidogrel DAPT compared to aspirin plus clopidogrel DAPT could reduce the risk of bleeding events while preserving ischemic protection during both the first and second 6 months post-PCI. Indobufen presents an effective option for patients with MVD, especially those at high ischemic risk requiring DAPT beyond 6 months post-PCI.

Trial registration: The trial was registered at www.chictr.org. A Randomized Controlled Trial of Indobufen versus Aspirin after Coronary Drug-eluting Stent Implantation: the OPTION Trial (ChiCTR-IIR-17013505).

Keywords: drug-eluting stent; dual antiplatelet therapy; indobufen; multivessel coronary disease.