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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)

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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.

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Authors and Affiliations

  1. Kobe University Graduate School of Medicine, Kobe, Japan

    Yoshiro Tsukiyama, Toshiro Shinke, Hiromasa Otake, Daisuke Terashita & Ken-ichi Hirata

  2. Kansai Rosai Hospital, Amagasaki, Japan

    Takayuki Ishihara, Masaaki Uematsu & Osamu Iida

  3. Osaka Saiseikai Nakatsu Hospital, Osaka, Japan

    Amane Kozuki & Junya Shite

  4. Hyogo College of Medicine, Nishinomiya, Japan

    Masashi Fukunaga, Tetsuo Horimatsu & Kenichi Fujii

  5. Omihachiman Community Medical Center, Shiga, Japan

    Kan Zen

  6. Osaka University Graduate School of Medicine, Osaka, Japan

    Mitsuyoshi Takahara

  7. Nishinomiya Municipal Central Hospital, Nishinomiya, Japan

    Shinsuke Nanto

  8. Division of Cardiovascular Medicine, Showa University School of Medicine, 1-5-8, Hatanodai, Shinagawa-ku, Tokyo, 142-8666, Japan

    Toshiro Shinke

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  1. Yoshiro Tsukiyama
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Corresponding author

Correspondence to Toshiro Shinke.

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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.

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A local ethical committee approved this study.

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

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Tsukiyama, Y., Shinke, T., Ishihara, T. et al. 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). Int J Cardiovasc Imaging 35, 1777–1784 (2019). https://doi.org/10.1007/s10554-019-01638-1

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