STELLIUM 1: First-In-Man Follow-up Evaluation of Bioabsorbable Polymer-Coated Paclitaxel-Eluting Stent

• Kozuki Amane

  Division of Cardiovascular Medicine, Department of Internal Medicine, Kobe University Graduate School of Medicine

• Shite Junya

  Division of Cardiovascular Medicine, Department of Internal Medicine, Kobe University Graduate School of Medicine

• Shinke Toshiro

  Division of Cardiovascular Medicine, Department of Internal Medicine, Kobe University Graduate School of Medicine

• Miyoshi Naoki

  Division of Cardiovascular Medicine, Department of Internal Medicine, Kobe University Graduate School of Medicine

• Sawada Takahiro

  Division of Cardiovascular Medicine, Department of Internal Medicine, Kobe University Graduate School of Medicine

• Hellig Farrel

  Sunward Park Hospital

• Abelson Mark

  Vergelegen Hospital

• Brown Basil

  PE Provincial Hospital

• Khan Sajidah

  Inkosi Albert Luthuli Hospital

• Mpe Martin

  Groote Schuur Hospital

• Ntsekhe Mpiko

  First Military Hospital

• Conway Damian

  Disa Vascular (Pty) Ltd

• Hirata Ken-ichi

  Division of Cardiovascular Medicine, Department of Internal Medicine, Kobe University Graduate School of Medicine

Abstract

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 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^TM 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^TM stent compared with the first-generation DES. (Circ J 2010; 74: 2089-2096)<br>

Journal

• Circulation Journal

  Circulation Journal 74 (10), 2089-2096, 2010

  The Japanese Circulation Society

Keywords

• Bioabsorbable polymer
• Neointima
• Optical coherence tomography
• Paclitaxel eluting stents

Details

• CRID: 1390282680078555648
• NII Article ID: 10026640146
• NII Book ID: AA11591968
• DOI: 10.1253/circj.cj-09-0859
• ISSN: 13474820
• ISSN: 13469843
• HANDLE: 20.500.14094/90001696
• Web Site: http://www.jstage.jst.go.jp/article/circj/74/10/74_CJ-09-0859/_pdf
• Web Site: https://search.jamas.or.jp/link/ui/2011066627
• Text Lang: en
• Data Source:
  • JaLC
  • IRDB
  • Crossref
  • CiNii Articles
• Abstract License Flag: Disallowed