Intermediate results of the prospective randomized study on the effect of lamina vastoadductoria dissection after superficial femoral artery stenting on the restenosis incidence in TASC-II type C and D lesions

Abstract

Aim. To compare the effectiveness of superficial femoral artery (SFA) stenting with/without lamina vastoadductoria dissection.Material and methods. The study included are 70 patients with TASCII type C and D lesions. All patients were divided onto 2 groups: group 1 (n=35) — conventional SFA stenting, group 2 (n=35) — SFA stenting with lamina vastoadductoria dissection. The average lesion length in group 1 was 22,92±5,62 cm, in group 2 — 21,2±5,42 cm. The primary endpoint was the absence of binary restenosis and reocclusion. Secondary composite endpoint was procedural success, limb salvage, secondary patency of the operated segment, intraoperative complications. The groups were comparable in age, sex, risk factors and comorbidities.Results. The procedural success in both groups was 100%. Primary patency after 24 months was 28,5% in group 1 and 60% in group 2. During the 24-month follow-up period, we recorded 1 death in group 2 due to myocardial infarction. In group 1, 2 deaths due to myocardial infarction and pancreatic cancer metastasis were recorded. Limb salvage was 100% in both groups. There were no intraoperative complications in both groups.Conclusion. Lamina vastoadductoria dissection is safe and does not lead to limb functional limitations. Biomechanical changes in the distal SFA segment contribute to the improvement of primary patency after stenting of SFA long lesions. Preliminary results of the single-center pilot study demonstrate the safety and efficacy of SFA stenting with lamina vastoadductoria dissection, emphasizing the need for further larger studies to compare it with conventional stenting and to assess the effectiveness during the long-term follow-up.