Improving of the Long-term Results after Stenting of the Superficial Femoral Artery – Intermediate Results of a Pilot Prospective Randomized Study

Vladimir Starodubtsev ¹, Pavel Ignatenko ¹, Andrey Karpenko ¹, Artem Rabtsun ²

¹ Siberian Biomedical Research Center, Ministry for Public Health Care Russian Federation, Novosibirsk, Russia; ² Siberian Biomedical Research Center, Ministry for Public Health Care Russian Federation, Novosibissk, Russia;

Date, time and location: 2018.05.26 13:30, Exhibition area, 1st Floor. Zone – A

Abstract

Novosibirsk, Russian Federation

Objective:  to improve the long-term results of stenting of the superficial femoral artery (SFA) by increasing mobility of the distal segment of SFA in the Gunther channel.

Methods 

Fifty patients with TASC-II D lesions were randomized 1:1, 25 performed stenting of SFA (group 1) and 25 performed stenting of SFA, supplemented by the dissection of the lamina vastoadductoria (group 2). The distribution of limb ischemia (Rutherford) in the groups was as follows: in the first group 2 St – 18 (72%), 3 St – 4(16%), 5 St – 3(12%); in the second group 2 St – 20(80%), 3 St – 2(8%), 5, St – 3(12%). The number of implanted stents: in the first group – 1 stent 17(68%), 2 stent 8(32%); in the second group – 1 stent 18(72%), 2 stent 7(28%). The average length of lesions in the first group was 23.6 cm in the second group - 22.2 cm. Primary endpoint - patency of the vessel, which is defined as the absence of binary restenosis and reocclusion. Secondary composite endpoint is the success of the procedure, limb salvage, the secondary patency of the operated segment, and intraoperative complications. The groups were balanced by age, sex, risk factors and comorbidity.

Results 

The procedure was successful 100% in both groups. The primary patency after 9 months was 16 (64%) in the first group and 20 (80%) in the second group (p=0.2). There were no lethal outcomes during the period of observation. The limb salvage in both groups was 100%. No intraoperative complications in both groups.

Conclusions 

Dissection of the lamina vastoadductoria after stenting of the superficial femoral artery is safe and demonstrates a high primary patency of the operated segment. The method is required the long-term follow-up in patients with dissection of the lamina vastoadductoria.