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Mortality risk after use of a paclitaxel-coated stent in femoropopliteal peripheral artery disease

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Abstract

Although paclitaxel-based devices which demonstrated improved outcomes in the treatment of lower-extremity peripheral artery disease (PAD) have been used worldwide, Katsanos et al. reported a systematic review and summary-level meta-analysis of RCTs in which application of paclitaxel-based devices in the femoropopliteal artery was associated with an increased mortality risk. The purpose of this study was to describe the safety of endovascular therapy (EVT) using paclitaxel-coated stents for femoropopliteal disease by evaluating the mortality risk compared with patients treated with paclitaxel-free devices. A retrospective, multicenter, non-randomized study examined 481 de-novo symptomatic PAD patients treated in 13 Japanese medical centers from January 2011 to December 2015. The risk of all-cause mortality was analyzed between the 65 patients treated with a paclitaxel-coated stent (PTX-coated group) and 416 patients treated with an uncoated balloon or bare nitinol stent (PTX-free group). Overall survival of the PTX-coated group and the PTX-free group were compared after propensity score matching. The 2-year overall survival estimates were 87.7% in the PTX-coated group vs 88.7% in the PTX-free group. There were no significant differences in the mortality risk between the groups through a full follow-up of 2 years (p = 0.80). The multivariate cox proportional hazards model identified three significant predictors of mortality; age (HR, 1.08; 95% CI, 1.03–1.13; p = 0.002), hemodialysis (HR, 3.16; 95% CI, 1.34–7.42; p = 0.008), and albumin (g/dl) (HR, 0.46; 95% CI, 0.25–0.85; p = 0.01).

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Authors and Affiliations

  1. Cardiovascular Center Tokeidai Memorial Hospital, 2-3 North-1, East1, Chuo-Ku, Sapporo, Hokkaido, 060-0031, Japan

    Michinao Tan, Kazushi Urasawa, Taichi Hayashi & Yusuke Sato

  2. Sapporo Cardiovascular Clinic, Sapporo, Japan

    Takuya Haraguchi

  3. Heart Center, Kasukabe Chuo General Hospital, Saitama, Japan

    Hiroshi Ando

  4. Department of Cardiology, Japanese Red Cross Kyoto Daini Hospital, Kyoto, Japan

    Yoshinori Tsubakimoto

  5. Nagoya EVT Clinic, Nagoya, Japan

    Daisuke Kamoi

  6. Department of Cardiovascular Medicine, Toyohashi Heart Center, Aichi, Japan

    Maoto Habara

  7. Department of Cardiology, Tokyobay UrayasuIchikawa Medical Center, Chiba, Japan

    Tatsuya Nakama

  8. TOWN Homecare Clinic Itabashi, Tokyo, Japan

    Hiroshi Sakamoto

  9. Department of Cardiology, Japanese Red Cross Kyoto Daiichi Hospital, Kyoto, Japan

    Masayoshi Kimura

  10. Department of Cardiology, Yamato Seiwa Hospital, Yamato, Japan

    Tatsuki Doijiri

  11. Department of Cardiology, Fukuoka University School of Medicine, Fukuoka, Japan

    Makoto Sugihara

  12. Department of Cardiology, Fukuoka Wajiro Hospital, Fukuoka, Japan

    Yuki Imoto

  13. Department of Radiology, Tsuchiya General Hospital, Hiroshima, Japan

    Tomoyasu Sato

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  1. Michinao Tan
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  2. Kazushi Urasawa
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  16. Yusuke Sato
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Correspondence to Michinao Tan.

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The authors declare no association with any individual, company, or organization having a vested interest in the subject matter/products mentioned in this article.

Human rights and ethical standards

This study was approved by the ethics committee of each hospital and written informed consents were obtained from patients.

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Tan, M., Urasawa, K., Haraguchi, T. et al. Mortality risk after use of a paclitaxel-coated stent in femoropopliteal peripheral artery disease. Cardiovasc Interv and Ther 37, 136–144 (2022). https://doi.org/10.1007/s12928-020-00744-5

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  • DOI: https://doi.org/10.1007/s12928-020-00744-5

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