Efficacy and Safety of Dual-Drug-Eluting Stents for de Novo Coronary Lesions in South Korea-The Effect Trial

Abstract

BACKGROUND: Drug-eluting stents (DESs) are commonly used in percutaneous coronary intervention (PCI) procedures; however, complications including in-stent restenosis and stent thrombosis are significant challenges. The dual-DES is a stent that elutes two drugs to target various stages of the restenosis reaction. This study investigated the safety and efficacy of dual-DES in clinical practice. METHODS: This study included 375 patients who underwent PCI with Cilotax(™) or DXR(™) dual-DESs at one of 13 centers in South Korea. The primary endpoint was target lesion failure (TLF) within 1 year. The secondary endpoints were cardiac death, myocardial infarction (MI), target lesion revascularization (TLR), and stent thrombosis. RESULTS: The rates of TLF in dual-DESs (3.7%) were comparable to those reported in conventional DES. In addition, the DXR(™) group had a significantly lower rate of TLF than the Cilotax(™) group. In multivariate analysis, the DXR(™) group had a lower risk of TLF (adjusted hazard ratio (HR) 0.30, 95% CI 0.09-0.92, p = 0.036) and MI (adjusted HR 0.16, 95% CI 0.03-0.82, p = 0.027) than the Cilotax(™) group. CONCLUSION: Dual-DESs had similar clinical outcomes regarding efficacy and safety as conventional DES. Among the dual-DES, the DXR(™) stent as a new generation dual-DES had more favorable clinical outcomes than the Cilotax(™) stent.