Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Observational Study
. 2023 Nov-Dec;75(6):403-408.
doi: 10.1016/j.ihj.2023.09.002. Epub 2023 Sep 20.

Two-year clinical outcomes of drug-coated balloon angioplasty and angiographic predictors of restenosis among patients with de novo femoropopliteal lesions

Kohei Yamaguchi  1 , Shinsuke Mori  2 , Tomoya Fukagawa  2 , Toshihiko Kishida  2 , Takahide Nakano  2 , Shigemitsu Shirai  2 , Masafumi Mizusawa  2 , Kenji Makino  2 , Yohsuke Honda  2 , Masakazu Tsutsumi  2 , Norihiro Kobayashi  2 , Masahiro Yamawaki  2 , Yoshiaki Ito  2
Affiliations
Observational Study

Two-year clinical outcomes of drug-coated balloon angioplasty and angiographic predictors of restenosis among patients with de novo femoropopliteal lesions

Kohei Yamaguchi et al. Indian Heart J. 2023 Nov-Dec.

Abstract

Objectives: We analyzed the 2-year clinical outcomes of patients with de novo femoropopliteal (FP) lesions who underwent drug-coated balloon (DCB) angioplasty and the angiographic predictors of restenosis.

Methods: This single-center, retrospective, and observational study evaluated 129 de novo FP lesions treated with DCB angioplasty without bailout stenting. Clinical outcomes and risk factors for loss of primary patency were analyzed using univariate and multivariate Cox proportional hazards regression models.

Results: The participants were aged 48-93 (mean: 73.6 ± 9.8) years, and 31% were women. Approximately 33% of the patients were receiving regular dialysis, and 35% of the affected limbs had critical ischemia. The mean lesion length was 132 ± 96 mm, and the mean reference vessel diameter (RVD) was 4.7 ± 0.8 mm. Forty-three (33%) limbs had chronic total occlusion of the target artery segment. Fifty-seven (44%) and 72 (56%) lesions were treated with DCB angioplasty using IN.PACT Admiral and Lutonix, respectively. The primary patency and amputation-free survival at 2 years were 59.3% and 89.5%, respectively. RVD was found to be an independent predictor of loss of primary patency. Based on the receiver operating characteristic analysis, an RVD of 4.2 mm was the best predictor of loss of primary patency at 2 years.

Conclusions: The short-term clinical outcome of DCB angioplasty for de novo FP lesions was acceptable. Moreover, an RVD of <4.2 mm was an independent predictor of restenosis after DCB angioplasty.

Keywords: Drug-coated balloon angioplasty; Endovascular treatment; Femoropopliteal artery.

PubMed Disclaimer

Conflict of interest statement

Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.

Figures

Fig. 1
Fig. 1
Flowchart of participant selection. DCB drug-coated balloon, FP femoropopliteal.
Fig. 2
Fig. 2
Kaplan–Meier curves for primary patency and AFS. (A) The primary patency rate at 2 years was 59.3%. (B) The AFS rate at 2 years was 89.5%. AFS amputation-free survival, EVT endovascular treatment.
Fig. 3
Fig. 3
Receiver operating characteristic analysis of reference vessel diameter for predicting the loss of primary patency. AUC area under curve, CI confidence interval.
Fig. 4
Fig. 4
Kaplan–Meier curves for primary patency stratified according to reference vessel diameter. RVD reference vessel diameter, EVT endovascular treatment.
See this image and copyright information in PMC

References

    1. Aboyans V., Ricco J.B., Bartelink M.L., et al. ESC guidelines on the diagnosis and treatment of peripheral arterial diseases, in collaboration with the European Society for Vascular Surgery (ESVS) Eur Heart J. 2017;39:763–816. - PubMed
    1. Laird J.A., Schneider P.A., Jaff M.R., et al. Long-term clinical effectiveness of a drug-coated balloon for the treatment of femoropopliteal lesions. Circ Cardiovasc Interv. 2019;12 doi: 10.1161/CIRCINTERVENTIONS.118.007702. - DOI - PMC - PubMed
    1. Rosenfield K., Jaff M.R., White C.J., et al. Trial of a paclitaxel-coated balloon for femoropopliteal artery disease. N Engl J Med. 2015;373:145–153. doi: 10.1056/NEJMoa1406235. - DOI - PubMed
    1. Steiner S., Willfort-Ehringer A., Sievert H., et al. 12-month results from the first-in-human randomized study of the ranger paclitaxel-coated balloon for femoropopliteal treatment. JACC Cardiovasc Intv. 2018;11:934–941. doi: 10.1016/j.jcin.2018.01.276. - DOI - PubMed
    1. Soga Y., Iida O., Urasawa K., et al. Three-year results of the IN.PACT SFA Japan trial comparing drug-coated balloons with percutaneous transluminal angioplasty. J Endovasc Ther. 2020;27:946–955. doi: 10.1177/1526602820948240. - DOI - PMC - PubMed

Publication types

Substances