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Safety Issues Associated with Paclitaxel-Eluting Balloons and Progress of Sirolimus-Eluting Balloons

Received: 1 February 2020    Accepted: 14 September 2020    Published: 19 September 2020
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Abstract

Drug eluting balloons (DEBs) are semi-compliant angioplasty balloons covered with an antiproliferative drug which is rapidly released locally into the vessel wall during balloon contact. Their advantages include a broader area of drug contact, more homogenous drug-tissue transfer for stent-based local drug delivery, no implant leaving as well as shortened dual antiplatelet therapy. DEBs application was first recommended by the European Society of Cardiology (ESC) and European Association for Cardio-Thoracic Surgery (EACTS) guidelines for the treatment of in-stent restenosis (ISR) after prior bare-metal stent (BMS) (Class IIA, Level B) in 2010. Since then, rapid progress has been made in the use of DEBs for treatment of in-stent restenosis, bifurcation, small vessel diseases, and other de novo occlusive coronary artery diseases even the symptomatic peripheral arterial disease. However, a meta-analysis of 28 randomized controlled trials (RCTs) with 4663 patients investigating paclitaxel-coated devices (DEBs & drug-eluting stent) in the femoral and/or popliteal arteries showed a highly significant association between risk of death and paclitaxel exposure in a dose-time-dependent manner. Safety issues associated with clinical application of paclitaxel DEBs in femoropopliteal artery was widely discussed. This study reviewed the issues, different molecular mechanisms of paclitaxel and sirolimus in antiproliferative effects, and progress of sirolimus-eluting balloons.

Published in International Journal of Cardiovascular and Thoracic Surgery (Volume 6, Issue 5)
DOI 10.11648/j.ijcts.20200605.11
Page(s) 54-59
Creative Commons

This is an Open Access article, distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution and reproduction in any medium or format, provided the original work is properly cited.

Copyright

Copyright © The Author(s), 2024. Published by Science Publishing Group

Keywords

Drug Eluting Balloons, Paclitaxel-Eluting Balloons, Sirolimus-Eluting Balloons

References
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Cite This Article
  • APA Style

    Yu Xia Yin, Zhi Yong Wang, Lu Ning Wang, Ming Kun Cao, Tian Heng Lu, et al. (2020). Safety Issues Associated with Paclitaxel-Eluting Balloons and Progress of Sirolimus-Eluting Balloons. International Journal of Cardiovascular and Thoracic Surgery, 6(5), 54-59. https://doi.org/10.11648/j.ijcts.20200605.11

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    ACS Style

    Yu Xia Yin; Zhi Yong Wang; Lu Ning Wang; Ming Kun Cao; Tian Heng Lu, et al. Safety Issues Associated with Paclitaxel-Eluting Balloons and Progress of Sirolimus-Eluting Balloons. Int. J. Cardiovasc. Thorac. Surg. 2020, 6(5), 54-59. doi: 10.11648/j.ijcts.20200605.11

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    AMA Style

    Yu Xia Yin, Zhi Yong Wang, Lu Ning Wang, Ming Kun Cao, Tian Heng Lu, et al. Safety Issues Associated with Paclitaxel-Eluting Balloons and Progress of Sirolimus-Eluting Balloons. Int J Cardiovasc Thorac Surg. 2020;6(5):54-59. doi: 10.11648/j.ijcts.20200605.11

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  • @article{10.11648/j.ijcts.20200605.11,
      author = {Yu Xia Yin and Zhi Yong Wang and Lu Ning Wang and Ming Kun Cao and Tian Heng Lu and Hai Jun Zhang},
      title = {Safety Issues Associated with Paclitaxel-Eluting Balloons and Progress of Sirolimus-Eluting Balloons},
      journal = {International Journal of Cardiovascular and Thoracic Surgery},
      volume = {6},
      number = {5},
      pages = {54-59},
      doi = {10.11648/j.ijcts.20200605.11},
      url = {https://doi.org/10.11648/j.ijcts.20200605.11},
      eprint = {https://article.sciencepublishinggroup.com/pdf/10.11648.j.ijcts.20200605.11},
      abstract = {Drug eluting balloons (DEBs) are semi-compliant angioplasty balloons covered with an antiproliferative drug which is rapidly released locally into the vessel wall during balloon contact. Their advantages include a broader area of drug contact, more homogenous drug-tissue transfer for stent-based local drug delivery, no implant leaving as well as shortened dual antiplatelet therapy. DEBs application was first recommended by the European Society of Cardiology (ESC) and European Association for Cardio-Thoracic Surgery (EACTS) guidelines for the treatment of in-stent restenosis (ISR) after prior bare-metal stent (BMS) (Class IIA, Level B) in 2010. Since then, rapid progress has been made in the use of DEBs for treatment of in-stent restenosis, bifurcation, small vessel diseases, and other de novo occlusive coronary artery diseases even the symptomatic peripheral arterial disease. However, a meta-analysis of 28 randomized controlled trials (RCTs) with 4663 patients investigating paclitaxel-coated devices (DEBs & drug-eluting stent) in the femoral and/or popliteal arteries showed a highly significant association between risk of death and paclitaxel exposure in a dose-time-dependent manner. Safety issues associated with clinical application of paclitaxel DEBs in femoropopliteal artery was widely discussed. This study reviewed the issues, different molecular mechanisms of paclitaxel and sirolimus in antiproliferative effects, and progress of sirolimus-eluting balloons.},
     year = {2020}
    }
    

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  • TY  - JOUR
    T1  - Safety Issues Associated with Paclitaxel-Eluting Balloons and Progress of Sirolimus-Eluting Balloons
    AU  - Yu Xia Yin
    AU  - Zhi Yong Wang
    AU  - Lu Ning Wang
    AU  - Ming Kun Cao
    AU  - Tian Heng Lu
    AU  - Hai Jun Zhang
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    JF  - International Journal of Cardiovascular and Thoracic Surgery
    JO  - International Journal of Cardiovascular and Thoracic Surgery
    SP  - 54
    EP  - 59
    PB  - Science Publishing Group
    SN  - 2575-4882
    UR  - https://doi.org/10.11648/j.ijcts.20200605.11
    AB  - Drug eluting balloons (DEBs) are semi-compliant angioplasty balloons covered with an antiproliferative drug which is rapidly released locally into the vessel wall during balloon contact. Their advantages include a broader area of drug contact, more homogenous drug-tissue transfer for stent-based local drug delivery, no implant leaving as well as shortened dual antiplatelet therapy. DEBs application was first recommended by the European Society of Cardiology (ESC) and European Association for Cardio-Thoracic Surgery (EACTS) guidelines for the treatment of in-stent restenosis (ISR) after prior bare-metal stent (BMS) (Class IIA, Level B) in 2010. Since then, rapid progress has been made in the use of DEBs for treatment of in-stent restenosis, bifurcation, small vessel diseases, and other de novo occlusive coronary artery diseases even the symptomatic peripheral arterial disease. However, a meta-analysis of 28 randomized controlled trials (RCTs) with 4663 patients investigating paclitaxel-coated devices (DEBs & drug-eluting stent) in the femoral and/or popliteal arteries showed a highly significant association between risk of death and paclitaxel exposure in a dose-time-dependent manner. Safety issues associated with clinical application of paclitaxel DEBs in femoropopliteal artery was widely discussed. This study reviewed the issues, different molecular mechanisms of paclitaxel and sirolimus in antiproliferative effects, and progress of sirolimus-eluting balloons.
    VL  - 6
    IS  - 5
    ER  - 

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Author Information
  • National United Engineering Laboratory for Biomedical Material Modification, Dezhou, China

  • Department of Emergency, Inner Mongolia people's Hospital, Hohhot, China

  • School of Materials Science and Engineering, University of Science and Technology, Beijing, China

  • National United Engineering Laboratory for Biomedical Material Modification, Dezhou, China

  • National United Engineering Laboratory for Biomedical Material Modification, Dezhou, China

  • National United Engineering Laboratory for Biomedical Material Modification, Dezhou, China

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