First Report of the Resolute Onyx 2.0 mm Zotarolimus-Eluting Stent for the Treatment of Coronary Lesions with Very Small Reference Vessel Diameter

Abstract Objective To explore the safety and efficacy of a dedicated drug-eluting stent (DES) for the treatment of coronary lesions with very small reference vessel diameter (RVD). Background Smaller RVD is associated with increased risk of restenosis and target lesion failure (TLF) after stent implantation. Methods This was a prospective, single-arm, multicenter trial of the Resolute Onyx 2.0mm zotarolimus-eluting stent (ZES). The primary endpoint was 12-month TLF, which was compared with a pre-specified performance goal. Subjects with stable or unstable angina or ischemia, target lesions ≤27mm in length and RVD ≥2.0 and Results A total of 101 subjects with 104 lesions were enrolled. The mean age was 67.3±9.6 years, 47% of subjects were diabetic, the mean lesion length was 12.6±6.3mm and the mean RVD was 1.91±0.26 mm. The rate of TLF at 12 months was 5.0%, fulfilling the pre-specified performance goal of 19% (p Conclusions In this first report of a DES with a dedicated size to treat lesions with RVD