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Clinical outcome of drug-coated balloon versus scaffold device in patients with superficial femoral artery chronic total occlusion

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Abstract

The demand for endovascular therapy is increasing in an aging society, but the problem of restenosis in the chronic phase has not been resolved in femoropopliteal occlusive disease. Few studies have compared drug-coated balloon (DCB) and scaffold devices in chronic total occlusion (CTO) of the superficial femoral artery (SFA). This study aimed to compare DCBs with scaffold in patients with CTO of the SFA. This was a single-center, retrospective study. From June 2018 to December 2019, we compared 31 patients and 33 limbs treated with DCBs and 44 patients and 45 limbs treated with a stent or stent-graft (scaffold) for SFA CTO. The primary endpoint was 12-month primary patency. The secondary endpoints were 12-month freedom from clinically driven target lesion revascularization (CD-TLR) and 12-month freedom from re-occlusion. The DCBs were performed using an intravascular ultrasound (IVUS)-guided approach or a non-loop wire technique. Baseline characteristics were similar between the groups. An intraluminal approach was performed to use all DCBs. The bailout stent rate was 0% in the DCB group. Kaplan–Meier analysis showed that rates of 12-month primary patency tended to be higher in the DCB than in the scaffold group (92.7 vs. 76.6%, p = 0.073) and that freedom from CD-TLR also did not differ significantly between the two groups (96.8 vs. 86.3%, p = 0.17). Kaplan–Meier analysis also showed that the 12-month freedom from re-occlusion rate was significantly less in the Scaffold than in the DCB group (96.8 vs. 79.3%, p = 0.045). Therefore, we concluded that in treatment for CTO of the SFA, a DCB with intraluminal angioplasty without bailout stenting was less re-occlusion compared with scaffold.

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Acknowledgements

We thank Ellen Knapp, PhD, from Edanz Group (https://jp.edanz.com/ac), for editing a draft of this manuscript.

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This research received no specific grants from any funding agency in the public, commercial, or not-for-profit sectors.

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Authors and Affiliations

  1. Department of Cardiovascular Medicine, Asahi General Hospital, I-1326 Asahi, , Chiba, 289-2511, Japan

    Naoki Hayakawa, Masataka Arakawa, Satoshi Hirano, Sandeep Shakya & Junji Kanda

  2. Department of Cardiovascular Medicine, University of Tokyo Hospital, Tokyo, Japan

    Satoshi Kodera

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  1. Naoki Hayakawa
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  2. Satoshi Kodera
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  3. Masataka Arakawa
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Correspondence to Naoki Hayakawa.

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All procedures were performed in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Declaration of Helsinki and its later amendments or comparable ethical standards. The study was approved by the Institutional Review Board (IRB) of Asahi General Hospital.

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Hayakawa, N., Kodera, S., Arakawa, M. et al. Clinical outcome of drug-coated balloon versus scaffold device in patients with superficial femoral artery chronic total occlusion. Heart Vessels 37, 282–290 (2022). https://doi.org/10.1007/s00380-021-01912-0

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