Efficacy and Safety Comparison of the Open (Femoral-popliteal Distal Bypass by Synthetic Vascular Graft) and Endovascular (Recanalization With Angioplasty and Stenting With Biomimetic Interwoven Nitinol Stent) Surgical Methods for the Treatment of Long Atherosclerotic Lesions of the Femoral-popliteal Segment Below the Knee, TASC D in Patients With Critical Limb Ischemia

Steno-occlusive lesion of the superficial femoral and popliteal artery is observed from 2.5% to 14.5% (National guidelines for the management of patients with vascular arterial pathology, Russian Consensus Document, 2010) of patients in different age groups. The standard technique of autovenous femoral-femoral or femoral-popliteal bypass surgery has shown its five-year effectiveness in 66-73.7% of patients (Remote endarterectomy versus supragenicular bypass surgery for long occlusions of the superficial femoral artery: Medium-term results of a randomized controlled trial (The REVAS trial ). by Suzanne S. Gisbertz, Rudolf P. Tutein Nolthenius, Gert Jan De Borst, Lyckle Van Der Laan, Tim Th C Overtoom, Frans L. Moll, Jean Paul PM De Vries 2010). However, these results are significantly impaired by femoral-popliteal bypass grafting below the knee joint, or femoral-tibial revascularization. In this position, five-year patency is 33-50% (Johnson WC, Lee KK A comparative evaluation of polytetra-fluoroethylene, umbilical vein, and saphenous vein bypass grafts for femoral-popliteal above-knee revascularization: a prospective randomized Department of Veterans Affairs cooperative study. J. Vasc. Surg). Patients whose own vein was previously used for coronary artery bypass grafting or has a small diameter and extensive lateral branches are also very problematic for surgery. At the same time, in patients with relatively compensated chronic ischemia of the lower extremities (CLI category 2-3 according to the Rutherford classification) and the absence of autologous material for shunting, it is possible to continue with optimal drug therapy. In the case of critical lower limb ischemia (category 4-6 according to the Rutherford classification), revascularization is indicated in order to preserve the limb (National guidelines for the diagnosis and treatment of diseases of the lower limb arteries, Section 7, pp. 59-61. Moscow, 2019). A common operation of percutaneous transluminal angioplasty with stenting of these arteries allows you to restore blood flow through your own arteries. However, with physiological flexion and extension of the hip and knee joints, there is a pronounced deformation of the stented popliteal and superficial femoral arteries both in the axial and angular directions. This is accompanied by breakage of the stents, or their restenosis and thrombosis. So, according to a number of authors, the two-year incidence of stent breakages in the superficial femoral artery ranges from 20% to 46% (Duda SH, Bosiers M, Lammer J, et al. Drug-eluting and bare nitinol stents for the treatment of atherosclerotic lesions in the superficial femoral artery: Long-term results from the SIROCCO trial. J Endovasc Ther 2006; 13: 701-710), and the frequency of restenosis and occlusions from 21.8% to 53.3% (Laird JR, Katzen BT, Scheinert D, et al. Nitinol stent implantation vs. balloon angioplasty for lesions in the superficial femoral and proximal popliteal arteries of patients with claudication: Three-year follow-up from the RESILIENT randomized trial. J Endovasc Ther 2012; 19: 1-9).

One of the possible solutions to the problem of stent breakage in the femoral-popliteal position is a modified method of their manufacture by braiding from nitinol wire. Pilot two-year studies with braided stents have indeed shown resistance to breakage in this position. Moreover, the frequency of restenosis was observed in 27.2% of patients (M. Werner, A. Paetzold, U. Banning-Eichenseer, S. Scheinert, M. Piorkowski, M. Ulrich, Y. Bausback, S. Bräunlich, A. Schmidt, D. Scheinert. Treatment of complex atherosclerotic femoropopliteal artery disease with a self-expanding interwoven nitinol stent: midterm results from the Leipzig SUPERA 500 registry // EuroIntervention 2014; March 2014).

At the same time, a recent study, where the authors studied the effectiveness of stenting of long lesions (200 mm or more) of the femoral-popliteal segment with BRM stents, showed unsatisfactory indicators (45%) of the patency of the stented segment within 2 years (Lin Y, Tang X, Fu W, Kovach R, George JC, Guo D. Stent fractures after superficial femoral artery stenting: risk factors and impact on patency. Journal of Endovascular Therapy. 2015 Jun; 22 (3): 319-26). This fact proves the need for a comparative study on such a cohort of patients using a interwoven nitinol stent, devoid of some of the disadvantages of usual BRM stents (as described above), which will improve the efficiency of this procedure both in the early and late postoperative period. Recently published by authors (Garcia L, Jaff MR, Metzger C, Sedillo G, Pershad A, Zidar F, Patlola R, Wilkins RG, Espinoza A, Iskander A, Khammar GS Wire-interwoven nitinol stent outcome in the superficial femoral and proximal popliteal arteries: twelve-month results of the SUPERB trial) the results of the effectiveness of such a procedure within 12 months, but with a shorter average length of the lesion (78.1 mm) showed encouraging results (the primary 12-month patency was 78.9%), which gives hope for good results even with long lesions.

Technology description:

Recanalization with angioplasty and stenting: Under local anesthesia, a standard endovascular approach is performed and the affected arterial segment is visualized. Perform transluminal or subintimal recanalization of the occluded segment of the arteries with a hydrophilic guide wire. Next, balloon angoplasty of the recanalized segment is performed. After control angiography, a biomimetic braided nitinol stent is placed throughout the lesion.