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

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.

1. Ostchega Y, Paulose‐Ram R, Dillon CF, et al. Prevalence of peripheral arterial disease and risk factors in persons aged 60 and older: data from the National Health and Nutrition Examination Survey 1999-2004. J Am Geriatr Soc. 2007;55(4):583-9. doi:10.1111/j.1532-5415.2007.01123.x.

2. Fowkes FGR, Rudan D, Rudan I, et al. Comparison of global estimates of prevalence and risk factors for peripheral artery disease in 2000 and 2010: a systematic review and analysis. The Lancet. 2013;382(9901):1329-40. doi:10.1016/S0140-6736(13)61249-0.

3. Balzer JO, Thalhammer A, Khan V, et al. Angioplasty of the pelvic and femoral arteries in PAOD: results and review of the literature. Eur J Radiol. 2010;75(1):48-56. doi:10.1016/j.ejrad.2010.04.016.

4. Gallagher KA, Meltzer AJ, Ravin RA, et al. Endovascular management as first therapy for chronic total occlusion of the lower extremity arteries: comparison of balloon angioplasty, stenting, and directional atherectomy. J Endovasc Ther. 2011;18(5):624-7. doi:10.1583/11-3539.1.

5. de Boer SW, van den Heuvel DA, de Vries-Werson DA, et al. Shortterm Results of the RAPID Ra ndomized Trial of the Legflow P aclitaxel-Eluting Balloon With Supera Stenting vs Supera Stenting Alone for the Treatment of I nterme d iate and Long Superficial Femoral Artery Lesions. J Endovasc Ther. 2017;24(6):783-92. doi:10.1177/1526602817725062.

6. Tosaka A, Soga Y, Iida O, et al. Classification and clinical impact of restenosis after femoropopliteal stenting. JACC. 2012;59(1):16- 23. doi:10.1016/j.jacc.2011.09.036.

7. Scheinert D, Scheinert S, Sax J, et al. Prevalence and clinical impact of stent fractures after femoropopliteal stenting. JACC. 2005;45(2):312-5. doi:10.1016/j.jacc.2004.11.026.

8. Clark TW, Groffsky JL, Soulen MC. Predictors of long-term patency after femoropopliteal angioplasty: results from the STAR registry. J Vasc Interv Radiol.2001;12(8):923-33. doi:10.1016/S1051-0443(07)61570-X.

9. Adlakha S, Sheikh M, Wu J, et al. Stent fracture in the coronary and peripheral arteries. J Interv Cardiol. 2010;23(4):411-9. doi:10.1111/j.1540-8183.2010.00567.x.

10. Bosiers M, Torsello G, Gißler HM, et al. Nitinol stent implantation in long superficial femoral artery lesions: 12-month results of the DURABILITY I study. J Endovasc Ther. 2009;16(3):261-9. doi:10.1583/08-2676.1.

11. Dake MD, Ansel GM, Jaff MR, et al. Sustained safety and effectiveness of paclitaxel-eluting stents for femoropopliteal lesions: 2-year follow-up from the Zilver PTX randomized and single-arm clinical studies. JACC. 2013;61(24):2417-27. doi:10.1016/j.jacc.2013.03.034.

12. Rabtsun A, Karpenko A, Zoloev DG, et al. Remote Endarterectomy and Lamina Vastoadductoria Dissection Improves Superficial Femoral Artery Biomechanical Behavior during Limb Flexion. Ann Vasc Surg. 2018;50:112-8. doi:10.1016/j.avsg.2017.12.007.

13. Gerhard-Herman MD, Gornik HL, Barrett C, et al. 2016 AHA/ACC guideline on the management of patients with lower extremity peripheral artery disease: executive summary: a report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. JACC. 2017;69(11):1465- 508. doi:10.1016/j.jacc.2016.11.008.

14. Elmahdy MF, Buonamici P, Trapani M, et al. Long-Term Primary Patency Rate After Nitinol Self-Expandable Stents Implantation in Long, Totally Occluded Femoropopliteal (TASC II C & D) Lesions. Heart, Lung and Circulation. 2017;26(6):604-11. doi: 10.1016/j.hlc.2016.09.011.

15. Karaskov AM, Kamenskaya OV, Klinkova AS, et al. The functional state of peripheral perfusion in patients with combined lower limb ischemia and Type 2 diabetes mellitus during revascularization of the main arteries. Patologija krovoobrashhenija i kardiohirurgija. 2015;19(1):78-83. (In Russ.) doi:10.21688/1681-3472-2015-1-78-83.