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Vascular response to paclitaxel-eluting nitinol self-expanding stent in superficial femoral artery lesions: post-implantation angioscopic findings from the SHIMEJI trial (Suppression of vascular wall Healing after IMplantation of drug Eluting peripheral stent in Japanese patients with the Infra inguinal lesion: serial angioscopic observation)

  • Yoshiro Tsukiyama
  • Toshiro ShinkeEmail author
  • Takayuki Ishihara
  • Hiromasa Otake
  • Daisuke Terashita
  • Amane Kozuki
  • Masashi Fukunaga
  • Kan Zen
  • Tetsuo Horimatsu
  • Kenichi Fujii
  • Junya Shite
  • Masaaki Uematsu
  • Mitsuyoshi Takahara
  • Osamu Iida
  • Shinsuke Nanto
  • Ken-ichi Hirata
Original Paper
  • 12 Downloads

Abstract

The aim of this study was to elucidate the vascular responses to paclitaxel-eluting stent (Zilver PTX stent) in superficial femoral artery lesion at different elapsed times using angioscopy. Patients who received Zilver PTX stent implantation from five centers were enrolled. We performed angioscopic examinations at 2, 6, and 12 months after implantation and evaluated neointimal coverage (NIC) grade, intra-stent thrombus (IS-Th) grade, and presence of yellow plaque. NIC grade 0 was defined as stent struts exposed; grade 1, struts transparently visible although covered; grade 2, struts embedded in the neointima, but translucent; and grade 3, struts fully embedded and invisible. IS-Th was graded as follows: grade 0 (none), 1 (focal), and 2 (diffusely spread). Angioscopic follow-up evaluation was performed at 2 months (25 patients, 42 lesions), 6 months (18 patients, 23 stents), and 12 months (14 patients, 24 stents) after stent implantation. Dominant NIC grade significantly increased over time; however, 16.3% of the cases had NIC grade 1 or 2 at 12 months. IS-Th grade decreased; however IS-Th and yellow plaque were persistently observed in 62.5% and 83.3% cases, respectively, at 12 months. An ongoing healing response was observed at 12 months after implantation; however, thrombogenic findings were noted. Prolonged dual antiplatelet therapy could potentially enhance the clinical utility of Zilver PTX.

Keywords

Zilver PTX Intra-stent thrombus Neointimal coverage Angioscopy Superficial femoral artery Stent thrombosis 

Notes

Funding

There is no financial support with regard to this manuscript.

Compliance with ethical standards

Conflict of interest

Dr. Shinke, Dr. Otake, and Dr. Shite serve as members of the advisory board of Abbott Vascular, Inc. The authors have no conflicts of interest to declare.

Ethical approval

A local ethical committee approved this study.

Informed consent

All enrolled study patients provided written informed consent to participate in the study.

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Copyright information

© Springer Nature B.V. 2019

Authors and Affiliations

  • Yoshiro Tsukiyama
    • 1
  • Toshiro Shinke
    • 1
    • 8
    Email author
  • Takayuki Ishihara
    • 2
  • Hiromasa Otake
    • 1
  • Daisuke Terashita
    • 1
  • Amane Kozuki
    • 3
  • Masashi Fukunaga
    • 4
  • Kan Zen
    • 5
  • Tetsuo Horimatsu
    • 4
  • Kenichi Fujii
    • 4
  • Junya Shite
    • 3
  • Masaaki Uematsu
    • 2
  • Mitsuyoshi Takahara
    • 6
  • Osamu Iida
    • 2
  • Shinsuke Nanto
    • 7
  • Ken-ichi Hirata
    • 1
  1. 1.Kobe University Graduate School of MedicineKobeJapan
  2. 2.Kansai Rosai HospitalAmagasakiJapan
  3. 3.Osaka Saiseikai Nakatsu HospitalOsakaJapan
  4. 4.Hyogo College of MedicineNishinomiyaJapan
  5. 5.Omihachiman Community Medical CenterShigaJapan
  6. 6.Osaka University Graduate School of MedicineOsakaJapan
  7. 7.Nishinomiya Municipal Central HospitalNishinomiyaJapan
  8. 8.Division of Cardiovascular MedicineShowa University School of MedicineTokyoJapan

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