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Comparison Between Clinical Outcomes of Low- and High-Dose Paclitaxel Drug-Coated Balloon in Endovascular Therapy for Femoropopliteal Lesion

  • Clinical Investigation
  • ARTERIAL INTERVENTIONS
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Abstract

Purpose

There is a little datum about the impact of paclitaxel dosage in patients undergoing drug-coated balloons (DCB) in endovascular therapy (EVT) for femoropopliteal lesions. In the current study, the authors sought to compare the clinical outcomes of low-dose (LD) and high-dose (HD) paclitaxel DCBs for patients undergoing EVT for femoropopliteal lesions in a real-world setting.

Materials and methods

The study population was derived from a multicenter registry named “Evaluation of clinical outcome after endovascular therapy for femoropopliteal artery disease in Kanagawa” (LANDMARK registry). This registry consists of patients from 5 hospitals in Kanagawa, Japan. Overall, 1,378 patients with 1,777 lesions received treatment between July 2017 and June 2020. Among these, DCB angioplasty was performed in 477 patients (516 lesions). Propensity score matching analysis was performed to compare the clinical outcomes of LD-DCB (Lutonix; Becton Dickinson and Company, Franklin Lakes, New Jersey) and HD-DCB (IN.PACT Admiral; Medtronic Vascular, Santa Clara, CA, USA).

Results

A total of 160 matched pairs of lesions were analyzed. Primary patency and freedom from target lesion revascularization at 2 years were similar between the two groups (LD-DCB vs. HD-DCB: 72% vs. 70%, p = 0.53; and 75% vs. 73%, p = 0.59, respectively).

Conclusion

No significant differences were found in the clinical outcomes between LD-DCB and HD-DCB angioplasty for femoropopliteal lesions.

Level of Evidence

Level 3

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Data Availability

Due to the nature of this research, participants of this study did not agree for their data to be shared publicly, so supporting data are not available.

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Acknowledgements

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Funding

This study was not supported by any funding.

Author information

Authors and Affiliations

  1. Department of Cardiology, Saiseikai Yokohama City Eastern Hospital, 3-6-1 Shimosueyoshi, Tsurumi-ku, Yokohama, Kanagawa, 230-0012, Japan

    Shinsuke Mori, Yohsuke Honda, Masakazu Tsutsumi, Norihiro Kobayashi, Masahiro Yamawaki & Yoshiaki Ito

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

    Yasutaka Yamauchi

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

    Tatsuki Doijiri

  4. Department of Cardiology, Shonan Kamakura General Hospital, Kamakura, Japan

    Kazuki Tobita

  5. Cardiovascular Center, Yokosuka Kyosai Hospital, Yokosuka, Japan

    Keiichi Hishikari

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Contributions

Material preparation was performed by YI. Data collection was performed by YY, TD, KT, KH, YH, and MT. Data analysis was performed by SM and NK. The first draft of the manuscript was written by SM and MY.

Corresponding author

Correspondence to Shinsuke Mori.

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Conflict of Interest

Kazuki Tobita reports remuneration for lecture at Medtronic. All other authors report no conflict of interest

Ethics Approval

Approval was obtained from the local ethics committee. All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki Declaration and its later amendments or comparable ethical standards.

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Informed consent was obtained from all individual participants included in the study.

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Mori, S., Yamauchi, Y., Doijiri, T. et al. Comparison Between Clinical Outcomes of Low- and High-Dose Paclitaxel Drug-Coated Balloon in Endovascular Therapy for Femoropopliteal Lesion. Cardiovasc Intervent Radiol 46, 590–597 (2023). https://doi.org/10.1007/s00270-022-03289-7

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