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Penetration rate of the placement of a drug-eluting stent for the treatment of superficial femoral artery lesions in Japan

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Abstract

Stent placement for treating superficial femoral artery (SFA) lesions has been approved. The Zilver PTX stent, a drug-eluting stent (DES) for treating SFA lesions, has been available in Japan since 2012. However, the penetration rate of this DES has not yet been reported. This prospective multicenter registry study enrolled 314 patients (354 limbs) to be treated by stent placement in 2014 (UMIN000011551). The primary endpoint was the measurement of the penetration rate of the DES. The secondary endpoints were measuring the freedom from restenosis, freedom from target lesion revascularization (TLR), freedom from major adverse limb event (MALE), and the survival rate at 12 months postoperatively. Female patients comprised 28% participants. The mean age was 73.1 ± 9.2 years. A total of 56% patients had diabetes mellitus (DM), 36% patients were receiving hemodialysis, and 30% used cilostazol at baseline. The mean lesion length was 156 ± 101 mm, and the percentage of TASC II C/D lesions was 58%. Critical limb ischemia (CLI) was observed in 32% limbs. The penetration rates of the Zilver PTX stent were only 8%. The primary patency rate was similar between DES and bare-metal stents (BMS) at 12 months postoperatively (77 vs. 84%, p = 0.52). In this study, the rates of freedom from restenosis, freedom from TLR, freedom from MALE, and the survival rate at 12 months postoperatively were 83, 86, 85, and 89%, respectively. The penetration rate of a first-generation DES placement for treating SFA lesions is low in Japan. On the other hand, BMS is well utilized and its primary patency is acceptable.

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Authors and Affiliations

  1. Department of Cardiology, Saiseikai Yokohama City Eastern Hospital, Yokohama, Japan

    Shinsuke Mori & Keisuke Hirano

  2. Cardiovascular Center, Takatsu General Hospital, Kawasaki, Japan

    Yasutaka Yamauchi & Akira Miyamoto

  3. Cardiovascular Center, Synthesis Shinkawabashi Hospital, Kawasaki, Japan

    Eijiro Hayashi

  4. Department of Cardiology, Yamato-Seiwa Hospital, Yamato, Japan

    Tatsuki Doijiri

  5. Department of Cardiology, Nagatsuda Welfare General Hospital, Yokohama, Japan

    Takeshi Takamura

  6. Department of Cardiology, Showa University Fujigaoka Hospital, Yokohama, Japan

    Atsuo Maeda

  7. Department of Cardiology, Yokosuka City Hospital, Yokosuka, Japan

    Jun Okuda

  8. Department of Cardiology, Kawasaki Municipal Tama Hospital, Kawasaki, Japan

    Koichi Mizuno

  9. Department of Cardiology, Hiratsuka Kyosai Hospital, Hiratsuka, Japan

    Yuko Onishi

  10. Department of Cardiology, Yokohama Sakae Kyosai Hospital, Yokohama, Japan

    Taku Iwaki & Ichiro Michishita

  11. Cardiovascular Center, Yokohama City University Medical Center, Yokohama, Japan

    Kengo Tsukahara

  12. Division of Cardiology, Tokai University School of Medicine, Isehara, Japan

    Norihiko Shinozaki

  13. Division of Cardiology and Catheterization Laboratories, Showa University Northern Yokohama Hospital, Yokohama, Japan

    Hiroshi Araki

  14. Department of Cardiology, St. Marianna University School of Medicine, Kawasaki, Japan

    Ken Kongoji

  15. Department of Cardiology, Yokohama City University Hospital, Yokohama, Japan

    Teruyasu Sugano

Authors
  1. Shinsuke Mori
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  2. Keisuke Hirano
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  3. Yasutaka Yamauchi
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  4. Eijiro Hayashi
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  5. Tatsuki Doijiri
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  6. Takeshi Takamura
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  7. Atsuo Maeda
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  8. Jun Okuda
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  9. Koichi Mizuno
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  10. Yuko Onishi
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  11. Taku Iwaki
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  12. Kengo Tsukahara
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  13. Norihiko Shinozaki
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  14. Hiroshi Araki
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  15. Ken Kongoji
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  16. Teruyasu Sugano
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  17. Akira Miyamoto
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  18. Ichiro Michishita
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Corresponding author

Correspondence to Shinsuke Mori.

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Mori, S., Hirano, K., Yamauchi, Y. et al. Penetration rate of the placement of a drug-eluting stent for the treatment of superficial femoral artery lesions in Japan. Heart Vessels 32, 1093–1098 (2017). https://doi.org/10.1007/s00380-017-0982-7

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  • DOI: https://doi.org/10.1007/s00380-017-0982-7

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