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Retrospective analysis on diameters of drug-coated balloons and predilatation balloons in infra-inguinal endovascular treatment (RABBIT study)

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Abstract

This multicenter retrospective study assessed the clinical outcomes of endovascular therapy (EVT) using a drug-coated balloon (DCB) that was larger than the predilatation balloons for femoropopliteal artery lesions. We analyzed 1140 cases with symptomatic peripheral artery disease that underwent EVT with DCB for femoropopliteal lesions between 2017 and 2021. The primary endpoint was procedural failure, defined as a composite of deteriorated dissection and bailout stenting. The secondary endpoints included deteriorated dissection, bailout stenting, restenosis, and target lesion revascularization. We performed propensity score matching to compare the clinical outcomes between EVT with a DCB which was larger than the predilatation balloon (larger DCB) and EVT with a DCB which was not (nonlarger DCB). We assigned 276 cases to the larger DCB group and 864 cases to the nonlarger DCB group. Procedural failure was observed in 75 cases, whereas restenosis occurred in 282 cases during a mean follow-up period of 12.7 ± 9.7 months. Propensity score matching extracted 273 pairs with no intergroup difference in baseline characteristics, except the predilatation balloon size. Procedural failure (9.2% versus 6.1%, P = 0.11), deteriorated dissection and bailout stenting proportion (both P > 0.05), and 1-year rates of freedom from restenosis (82.4% versus 84.1%, P = 0.59) and target lesion revascularization (89.7% versus 90.4%, P = 0.83) showed no significant difference between the larger and nonlarger DCB groups. Irrespective of whether the DCB size was larger than the predilatation balloon, no difference was observed in either procedural or clinical outcomes.

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Data availability

The data that support the findings of this study are available from the corresponding author, YI on reasonable request. The raw data are not publicly available due to their containing information that could compromise the privacy of research participants.

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Funding

This study was not supported by any funding.

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Authors and Affiliations

  1. Department of Cardiology, Funabashi Municipal Medical Center, 1-21-1, Kanasugi, Funabashi, Chiba, 273-8588, Japan

    Yo Iwata & Shigeru Fukuzawa

  2. Department of Metabolic Medicine, Osaka University Graduate School of Medicine, Osaka, Japan

    Mitsuyoshi Takahara

  3. Department of Cardiology, Shonan Kamakura General Hospital, Kanagawa, Japan

    Kazuki Tobita

  4. Department of Cardiovascular Medicine, Asahi General Hospital, Chiba, Japan

    Naoki Hayakawa

  5. Department of Cardiology, Saiseikai Yokohama-City Tobu Hospital, Kanagawa, Japan

    Shinsuke Mori

  6. Department of Cardiology, Sendai Kousei Hospital, Miyagi, Japan

    Kazunori Horie

  7. Department of Cardiovascular Medicine, Tokyo-Bay Urayasu Ichikawa Medical Center, Chiba, Japan

    Tatsuya Nakama

  8. Department of Cardiology, Tokyo Saiseikai Central Hospital, Tokyo, Japan

    Kenji Suzuki

Authors
  1. Yo Iwata
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  2. Mitsuyoshi Takahara
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  3. Kazuki Tobita
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  4. Naoki Hayakawa
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  5. Shinsuke Mori
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  6. Kazunori Horie
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  7. Tatsuya Nakama
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  8. Kenji Suzuki
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  9. Shigeru Fukuzawa
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Contributions

All authors contributed to the study conception, design, and data collection. Analysis were performed by Mitsuyoshi Takahara. The first draft of the manuscript was written by Yo Iwata and all authors commented on previous versions of the manuscript. All authors read and approved the final manuscript.

Corresponding author

Correspondence to Yo Iwata.

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Conflict of interest

Tatsuya Nakama is a consultant for BD, Boston Scientific, Century Medical, Cook Medical, Cordis Cardinal Health, Kaneka Medix, NIPRO, and Orbus Neich. The remaining authors declare that they have no conflict of interest.

Ethics approval, consent to participate, and publish

The study protocol was approved by the local ethics committees at all participating centers, and the study was performed in accordance with the Declaration of Helsinki. The requirement for informed consent was waived considering the retrospective study design, where existing medical records were used.

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Iwata, Y., Takahara, M., Tobita, K. et al. Retrospective analysis on diameters of drug-coated balloons and predilatation balloons in infra-inguinal endovascular treatment (RABBIT study). Cardiovasc Interv and Ther (2024). https://doi.org/10.1007/s12928-024-01001-9

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  • DOI: https://doi.org/10.1007/s12928-024-01001-9

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