STELLIUM 1: First-in-man follow-up evaluation of bioabsorbable polymer-coated paclitaxel-eluting stent

Background: Durable polymers used for first-generation drug-eluting stents (DES) potentially contribute to persistent inflammation and late DES thrombosis. The vascular response to the Stellium™ stent, which is coated with an absorbable polymer for slow release of low-dose paclitaxel, was evaluated in the present study. Methods and Results: The 37 patients with stable angina were implanted with 47 Stellium™ stents. Quantitative coronary angiography (QCA) was performed at baseline, and QCA and optical coherence tomography (OCT) were performed at 6 months post-implant. The primary endpoint was major adverse cardiac events (MACE). At 6 months, 1 case of MACE occurred because of total occlusion of a protected left main artery. In-stent and segment binary restenosis rates were both 0%. In-stent late loss was 0.19±0.54 mm. Altogether, 5,564 struts were visualized by OCT and mean neointimal thickness was 150.03±146.36 μm. The number of well-apposed struts with and without neointima overlay was 5,135 (92.29%) and 396 (7.12%), respectively. Peri-strut low intensity was observed in 518 struts (9.31%). Conclusions: This first-in-man study of the Stellium™ stent shows the promising possibility of bioabsorbable polymeric surface coating paclitaxel-eluting stents out to 6 months. The low rate of peri-strut low intensity suggests low cellular toxicity of the Stellium™ stent compared with the first-generation DES.