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 (TM) 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 (TM) 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 mu m. The number of well-apposed struts with and without neointima overlay was 5,135 (92.29%) and 396 (7.12%), respectively. Pen-strut low intensity was observed in 518 struts (9.31%). Conclusions: This first-in-man study of the Stellium (TM) stent shows the promising possibility of bioabsorbable polymeric surface coating paclitaxel-eluting stents out to 6 months. The low rate of pen-strut low intensity suggests low cellular toxicity of the Stellium (TM) stent compared with the first-generation DES. (Circ J 2010; 74: 2089-2096)