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Open-label multicenter registry on the outcomes of peripheral arterial disease treated by balloon angioplasty with optical frequency domain imaging in superficial femoral artery and popliteal artery (OCEAN-SFA study)

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Abstract

Although balloon angioplasty for femoropopliteal artery lesions has been associated with restenosis rates of up to 60% at 12 months, the mechanism of restenosis has not been fully evaluated. The aim of this study was to evaluate the relationship between the vascular features observed on optical frequency domain imaging (OFDI) before and after balloon angioplasty of femoropopliteal artery lesions, and restenosis at 6 months. This study was a prospective multicenter single arm study. OFDI was performed before and after balloon angioplasty and plaque characteristics and vascular features, along with de novo lesions, were assessed. The primary outcome was the presence or absence of restenosis 6 months after balloon angioplasty. Residual platelet reactivity was assessed according to VerifyNow platelet reactivity units (PRUs). The number of patients completing 6 months of follow-up was 47, of which 14 had developed restenosis. Maximum thickness of the dissection flap (odds ratio (OR) 2.71; 95% confidence interval [0.9–8.0]; p = 0.071) and lesion length were identified as risk factors for restenosis (OR 1.015; 95% confidence interval [0.001–0.029]; p = 0.039). The mean PRU at the time of treatment in patients with restenosis was significantly higher than in those without restenosis (286.3 ± 82.6 vs. 208.5 ± 03.6, p = 0.026). Long lesions and major dissection on OFDI after balloon angioplasty for femoropopliteal artery lesions increase restenosis at 6 months. In addition, high residual platelet reactivity at the time of EVT may also be a risk factor for restenosis.

Clinical Trial Registration Number UMIN000021120.

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Funding

This study was funded by Daiichi-Sankyo Company, Limited. The funding body had no role in the design of the study, the statistical analysis, or in writing this manuscript.

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Author notes

  1. Yoshiro Tsukiyama, Akihide Konishi contributed equally to this work.

Authors and Affiliations

  1. Division of Cardiovascular Medicine, Department of Internal Medicine, Kobe University Graduate School of Medicine, Kobe, Japan

    Yoshiro Tsukiyama, Akihide Konishi, Toshiro Shinke, Hiromasa Otake, Hiroyuki Kawamori, Kenichi Yanaka & Ken-ichi Hirata

  2. Division of Cardiovascular Medicine, Hyogo Prefectural Himeji Cardiovascular Center, Himeji, Japan

    Yoshiro Tsukiyama

  3. Clinical and Translational Research Center, Kobe University Hospital, Kobe, Japan

    Akihide Konishi, Yasumasa Kakei, Isao Nanba & Takashi Omori

  4. Division of Cardiology, Department of Medicine, Showa University School of Medicine, 1-5-8 Hatanodai, Shinagawa-ku, Tokyo, 142-8555, Japan

    Toshiro Shinke & Naoki Matsukawa

  5. Division of Cardiology, Osaka Saiseikai Nakatsu Hospital, Osaka, Japan

    Amane Kozuki & Junya Shite

  6. Cardiovascular Center, Kansai Rosai Hospital, Amagasaki, Japan

    Osamu Iida & Takayuki Ishihara

  7. Department of Cardiology, Hyogo Prefectural Awaji Medical Center, Sumoto, Japan

    Takumi Inoue & Masamichi Iwasaki

  8. Kakogawa Central City Hospital, Kakogawa, Japan

    Makoto Kadotani

  9. Kobe Cardiovascular Core Laboratory, Kobe, Japan

    Naoki Matsukawa & Keiji Noutomi

Authors
  1. Yoshiro Tsukiyama
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  2. Akihide Konishi
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  3. Toshiro Shinke
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  4. Amane Kozuki
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  5. Hiromasa Otake
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  7. Kenichi Yanaka
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  16. Isao Nanba
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  19. Ken-ichi Hirata
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Corresponding author

Correspondence to Toshiro Shinke.

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Conflict of interest

Dr. Shinke have served as members of advisory boards of Abbott Vascular and received honoraria from Daiichi-Sankyo and Abbott Vascular. Dr. Otake have served as members of the advisory boards of Abbott Vascular. Dr. Kozuki have received honoraria from Daiichi-Sankyo and Abbott Vascular.

Ethics approval

The study protocol was approved by the ethical review board at each participating institution and performed according to the guidelines of the Declaration of Helsinki.

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Written informed consent to participate in this study was obtained from all patients.

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Tsukiyama, Y., Konishi, A., Shinke, T. et al. Open-label multicenter registry on the outcomes of peripheral arterial disease treated by balloon angioplasty with optical frequency domain imaging in superficial femoral artery and popliteal artery (OCEAN-SFA study). Cardiovasc Interv and Ther 36, 321–329 (2021). https://doi.org/10.1007/s12928-020-00679-x

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  • DOI: https://doi.org/10.1007/s12928-020-00679-x

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