Comparing the results of superficial femoral artery recanalization using drug-coated stents with and without adductor canal fasciotomy

• Cheban A.V.
• Osipova O.S.
• Khamyt K.A.
• Lysikov D.A.
• Ignatenko P.V.
• Gostev A.A.
• Saaya Sh.B.
• Karpenko A.A.

Abstract

Objective. This study was aimed at comparing the results of superficial femoral artery recanalization using a drug-coated stent with and without fasciotomy of the adductor canal during 2 years of follow-up.

Patients and methods. We conducted a randomized clinical trial of 60 (1:1) patients with TASC II type D extensive steno-occlusive lesions of the femoropopliteal segment. All patients underwent recanalization of the occluded femoropopliteal arterial segment with a drug-eluting stent. The difference to compare was that the patients of the study group (ZilverFas) were additionally subjected to fasciotomy of the adductor muscles at the level of the Hunter’s canal, whereas the control group (Zilver-alone) patients did not receive this supplementary procedure. Patency of the reconstruction zone was assessed after 24 months.

Results. Two-year primary patency in the study group was 60% and 33% in the control group (p=0.03). 24-month freedom from revascularization of the inflow and outflow arteries was 96% in the study group and 80% in the control group (log-rank, p=0.04). Primary assisted patency after 24 months was 66.5% in the study group versus 46.7% in the control group (log-rank, p=0.14). Two-year secondary patency was 69% in the study group versus 53.3% in the control group (log-rank, p=0.24). Breakdowns at 24 months decreased twofold (p=0.05).

After 12 months of follow-up, the number of asymptomatic patients in the ZilverFas group was significantly higher than in the control group (37 vs 13%, p=0.03).

Conclusion. Recanalization of the superficial femoral artery using a drug-coated stent in combination with fasciotomy of the adductor canal demonstrated better two-year primary patency and freedom from reoperation compared with recanalization not supplemented by fasciotomy.

Funding. The study was financially supported by a grant from the Russian Science Foundation, project № 23-75-10047 entitled “Development of new approaches to determining optimal technology of revascularization of the superficial femoral artery based on studying its biomechanics by means of ultrasound imaging, computational, experimental fluid dynamics and neural network analysis”.

Conflict of interest. The authors have no conflicts of interest to declare.

Authors’ contribution. Study conception and design – Karpenko A.A., Cheban A.V.; data collection and handling – Ignatenko P.V., Cheban A.V.; statistical processing – Gostev A.A., Osipova O.S.; draft manuscript preparation – Lysikov D.A., Khamyt K.A.; manuscript revision – Saaya Sh.B.-O.

Acknowledgements. The stents were provided by the COOK Medical Company free of charge.

For citation: Cheban A.V., Osipova O.S., Khamyt K.A., Lysikov D.A., Ignatenko P.V., Gostev A.A., Saaya Sh.B.-O, Karpenko A.A. Comparing the results of superficial femoral artery recanalization using drug-coated stents with and without adductor canal fasciotomy. Angiology and Vascular Surgery. Journal named after Academician A.V. Pokrovsky. 2024; 30 (2): 56–63. DOI: https://doi.org/10.33029/1027-6661-2024-30-2-56-63

Keywords:femoropopliteal lesions; fasciotomy; stenting; endovascular intervention