Comparative retrospective analysis of the results of open femoral-popliteal bypass grafting and endovascular stenting with an interwoven biomimetic stent in patients with prolonged occlusions of the arteries in the femoropopliteal segment

Introduction. Autovenous graft is considered the gold standard for prolonged occlusive lesions of the arteries in the femoralpopliteal segment. However, the vein is not always anatomically suitable for bypass grafting; it may have been previously used in previous operations, for example, in coronary artery bypass grafting. Open surgery is always more traumatic than endovascular surgery. Conventional nitinol stents show unsatisfactory results in the femoral-popliteal position due to the high percentage of reocclusions associated with their breakage during physiological movements in the leg joints. The modified method of making interwoven nitinol stents allows improving their biomimetic properties and reducing the percentage of breakages and, accordingly, reocclusions.

Material and Methods. There was a retrospective analysis of 437 patients with prolonged atherosclerotic occlusive lesion in the femoropopliteal segment (> 20 cm). There were two groups: a group of bypass surgery and a group of endovascular intervention. The pseudo-randomization method of propensity score matching was used to align the groups according to various criteria.

Results. Primary and secondary patency rates for one- and two-year follow up were comparable between the two groups. A subgroup analysis of above-knee intervention showed that a two-year secondary patency rate was significantly higher in the endovascular intervention group than in the bypass group (90.9% vs. 77.5%, p = 0.048). The subgroup analysis of interventions below the knee joint showed that the patency rates at two years of primary and primary-assisted patency were significantly higher in the endovascular intervention group than in the bypass group with an artificial expanded polytetrafluoroethylene (ePTFE) graft (66.7% versus 42.4%, p = 0.046 and 76.7% versus 45.5%, p = 0.011, respectively). The autovenous graft showed better results for primary patency compared with the endovascular intervention group, but the difference was statistically insignificant (77.2% versus 66.7%, respectively, p = 0.3).

Conclusion. The analysis of obtained results suggests that the primary endovascular strategy may be recommended for all prolonged occlusive lesions of the femoropopliteal segment above the knee joint gap. For lesions below the knee joint, the autovenous bypass grafting remains the operation of choice, but in the absence of a suitable autovenous graft, the primary endovascular strategy may also be recommended. Additional large multicenter randomized trials are required to refine these recommendations.

1. Norgren L., Hiatt W.R., Dormandy J.A., Nehler M.R., Harris K.A., Fowkes F.G.et al. Inter-Society Consensus for the Management of Peripheral Arterial Disease (TASC II). J. Vasc. Surg. 2007;45(S):S5–67. DОI: 10.1016/j.jvs.2006.12.037.

2. Jaff M.R., White C.J., Hiatt W.R., Fowkes G.R., Dormandy J., Razavi M. et al. An update on methods for revascularization and expansion of the TASC lesion classification to include below-the-knee arteries: A supplement to the Inter-Society Consensus for the Management of Peripheral Arterial Disease (TASC II): The TASC steering committee. Catheter Cardiovasc. Interv. 2015;86(4):611–625. DОI: 10.1002/ccd.26122.

3. National guidelines on the diagnosis and treatment of diseases of the arteries of the lower extremities. Moscow; 2019:110 (In Russ.).

4. Aboyans V., Ricco J.B., Bartelink M.E.L., Björck M., Brodmann M., Cohnert T. et al. 2017 ESC guidelines on the diagnosis and treatment of peripheral arterial diseases, in collaboration with the European Society for Vascular Surgery (ESVS): Document covering atherosclerotic disease of extracranial carotid and vertebral, mesenteric, renal, upper and lower extremity arteries. Endorsed by: the European Stroke Organization (ESO)The Task Force for the Diagnosis and Treatment of Peripheral Arterial Diseases of the European Society of Cardiology (ESC) and of the European Society for Vascular Surgery (ESVS). Eur. Heart J. 2018;39(9):763–816. DОI: 10.1093/eurheartj/ehx095.

5. Lin Y., Tang X., Fu W., Kovach R., George J.C., Guo D. Stent fractures after superficial femoral artery stenting: Risk factors and impact on patency. J. Endovasc. Ther. 2015;22(3):319–326. DОI: 10.1177/1526602815580783.

6. Duda S.H., Bosiers M., Lammer J., Scheinert D., Zeller T., Oliva V. 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(6):701–710. DОI: 10.1583/05-1704.1.

7. Laird J.R., Katzen B.T., Scheinert D., Lammer J., Carpenter J., Buchbinder M. 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):1–9. DОI: 10.1583/11-3627.1.

8. Werner M., Paetzold A., Banning-Eichenseer U., Scheinert S., Piorkowski M., Ulrich M. et al. Treatment of complex atherosclerotic femoropopliteal artery disease with a self-expanding interwoven nitinol stent: midterm results from the Leipzig SUPERA 500 registry. EuroIntervention. 2014;10(7):861–868. DОI: 10.4244/EIJV10I7A147.

9. Garcia L., Jaff M.R., Metzger C., Sedillo G., Pershad A., Zidar F. et al. Wire-interwoven nitinol stent outcome in the superficial femoral and proximal popliteal arteries: Twelve-month results of the SUPERB trial. Circ. Cardiovasc. Interv. 2015;8(5):e000014. DОI: 10.1161/CIRCINTERVENTIONS.113.000937.

10. Conte M.S., Bradbury A.W., Kolh P., White J.V., Dick F., Fitridge R. et al. Global vascular guidelines on the management of chronic limb-threatening ischemia. Eur. J. Vasc. Endovasc. Surg. 2019;58(1S):S1–S109.e33. DОI: 10.1016/j.ejvs.2019.05.006.

11. Ruzankin P.S. A fast algorithm for maximal propensity score matching. Methodol. Comput. Appl. Probab. 2020;(22):477–495. DОI: 10.1007/s11009-019-09718-4.

12. Okuno S., Iida O., Iida T., Yamaoka T., Kitano I., Asai M. et al. Comparison of clinical outcomes between endovascular therapy with self-expandable nitinol stent and femoral-popliteal bypass for trans-atlantic inter-society consensus II C and D femoropopliteal lesions. Ann. Vasc. Surg. 2019;57:137–143. DОI: 10.1016/j.avsg.2018.09.024.

13. Siracuse J.J., Giles K.A., Pomposelli F.B., Hamdan A.D., Wyers M.C., Chaikof E.L. et al. Results for primary bypass versus primary angioplasty/stent for intermittent claudication due to superficial femoral artery occlusive disease. J. Vasc. Surg. 2012;55(4):1001–1007. DОI: 10.1016/j.jvs.2011.10.128.

14. ihara H., Soga Y., Mii S., Okazaki J., Yamaoka T., Kamoi D. et al. Comparison of long-term outcome after endovascular therapy versus bypass surgery in claudication patients with Trans-Atlantic Inter-Society Consensus-II C and D femoropopliteal disease. Circ. J. 2014;78(2):457–464. DОI: 10.1253/circj.cj-13-1147.

15. Enzmann F.K., Nierlich P., Aspalter M., Hitzl W., Dabernig W., Hölzenbein T. et al. Nitinol stent versus bypass in long femoropopliteal lesions: 2-year results of a randomized controlled trial. JACC Cardiovasc. Interv. 2019;12(24):2541–2549. DОI: 10.1016/j.jcin.2019.09.006.

16. Lammer J., Zeller T., Hausegger K.A., Schaefer P.J., Gschwendtner M., Mueller-Huelsbeck S. et al. Sustained benefit at 2 years for covered stents versus bare-metal stents in long SFA lesions: Тhe VIASTAR trial. Cardiovasc. Intervent. Radiol. 2015;38(1):25–32. DОI: 10.1007/s00270-014-1024-9.

17. Reijnen M.M.P.J., van Walraven L.A., Fritschy W.M., Lensvelt M.M.A., Zeebregts C.J., Lemson M.S. et al. 1-year results of a multicenter randomized controlled trial comparing heparin-bonded endoluminal to femoropopliteal bypass. JACC Cardiovasc. Interv. 2017;10(22):2320–2331. DОI: 10.1016/j.jcin.2017.09.013.