Kozuki A., Shite J., Shinke T., Miyoshi N., Sawada T., Hellig F., Abelson M., Brown B., Khan S., Mpe M., Ntsekhe M., Conway D., Hirata K.-I.
Division of Cardiovascular Medicine, Department of Internal Medicine, Kobe University Graduate School of Medicine, Kobe, Japan; Sunward Park Hospital, Johannesburg, South Africa; Vergelegen Hospital, Somerset West, South Africa; PE Provincial Hospital, Port Elizabeth, South Africa; Inkosi Albert Luthuli Hospital, Durban, South Africa; Groote Schuur Hospital, Cape Town, South Africa; First Military Hospital, Pretoria, South Africa; Disa Vascular (Pty) Ltd, Cape Town, South Africa
Kozuki, A., Division of Cardiovascular Medicine, Department of Internal Medicine, Kobe University Graduate School of Medicine, Kobe, Japan; Shite, J., Division of Cardiovascular Medicine, Department of Internal Medicine, Kobe University Graduate School of Medicine, Kobe, Japan; Shinke, T., Division of Cardiovascular Medicine, Department of Internal Medicine, Kobe University Graduate School of Medicine, Kobe, Japan; Miyoshi, N., Division of Cardiovascular Medicine, Department of Internal Medicine, Kobe University Graduate School of Medicine, Kobe, Japan; Sawada, T., Division of Cardiovascular Medicine, Department of Internal Medicine, Kobe University Graduate School of Medicine, Kobe, Japan; Hellig, F., Sunward Park Hospital, Johannesburg, South Africa; Abelson, M., Vergelegen Hospital, Somerset West, South Africa; Brown, B., PE Provincial Hospital, Port Elizabeth, South Africa; Khan, S., Inkosi Albert Luthuli Hospital, Durban, South Africa; Mpe, M., Groote Schuur Hospital, Cape Town, South Africa; Ntsekhe, M., First Military Hospital, Pretoria, South Africa; Conway, D., Disa Vascular (Pty) Ltd, Cape Town, South Africa; Hirata, K.-I., Division of Cardiovascular Medicine, Department of Internal Medicine, Kobe University Graduate School of Medicine, Kobe, Japan
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.