OPTIMIZATION OF ENDOVASCULAR STRATEGY SELECTION IN PATIENTS WITH DIABETES MELLITUS AND CRITICAL LIMB ISCHEMIA: FROM EVIDENCE TO THE PLAN ALGORITHM

  2. 2026
  3. OPTIMIZATION OF ENDOVASCULAR STRATEGY SELECTION IN PATIENTS WITH DIABETES MELLITUS AND CRITICAL LIMB ISCHEMIA: FROM EVIDENCE TO THE PLAN ALGORITHM

Hmoshynskyi M. V., Bilonozhenko M. S., Pylypenko R. V.

OPTIMIZATION OF ENDOVASCULAR STRATEGY SELECTION IN PATIENTS WITH DIABETES MELLITUS AND CRITICAL LIMB ISCHEMIA: FROM EVIDENCE TO THE PLAN ALGORITHM

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About the author:

Hmoshynskyi M. V., Bilonozhenko M. S., Pylypenko R. V.

Heading:

LITERATURE REVIEWS

Type of article:

Scientific article

Annotation:

According to the IDF Diabetes Atlas (2025), 589 million adults aged 20–79 years were living with diabetes mellitus in 2024, representing 11.1% of this age group. This number is projected to increase to 853 million (13.0%) by 2050. The aim is to synthesize evidence published between 2016 and 2026 on endovascular revascularization in patients with diabetes mellitus and chronic limb-threatening ischemia, compare randomized trial findings with current guideline recommendations, and formulate an algorithm for selecting treatment strategies and devices according to the PLAN framework. A structured narrative review of literature published between 2016 and 2026 was conducted using PubMed/ MEDLINE, Scopus, Web of Science, the Cochrane Library, ClinicalTrials.gov, and ISRCTN. Following a multistage selection process, 45 publications were included in the analysis. The analysis showed that amputation-free survival, limb salvage, and the need for repeat revascularization should be considered the principal measures of treatment effectiveness. The BASIL-3 trial found no advantage of paclitaxel-coated balloons or drug-eluting stents over standard balloon angioplasty in terms of amputation-free survival. Similar findings were reported in SWEDEPAD 1, which demonstrated no reduction in the incidence of major amputation. In contrast, the multicenter SirPAD trial involving 1,252 patients showed that sirolimus-coated balloon angioplasty reduced the incidence of the primary endpoint to 8.8%, compared with 15.0%, and the composite secondary endpoint to 23.0%, compared with 30.8% after standard angioplasty (p=0.002). The selection of endovascular technology for patients with diabetes mellitus and chronic limb-threatening ischemia should be based on clinically meaningful outcomes. Sirolimus-coated balloons appear to be the most promising option, while the PLAN framework facilitates treatment personalization, improves limb salvage rates, and may enhance long-term outcomes.

Tags:

chronic limb-threatening ischemia, diabetes mellitus, drug-coated balloon, endovascular revascularization, limb salvage

Bibliography:

  1. Smorzhevskyi VY, Manasrakh RH. Vplyv revaskuliaryzatsii ta hlikemichnoho kontroliu na yakist zhyttia patsiientiv z arterialnoiu nedostatnistiu nyzhnikh kintsivok za tsukrovoho diabetu 2 typu. Kharkivska khirurhichna shkola. 2025;1(130):47-51. DOI: https://doi.org/10.37699/2308-7005.1.2025.08 [in Ukrainian].
  2. Magliano DJ, Boyko EJ. Diabetes Atlas 11th edition Scientific Committee. IDF Diabetes Atlas. 11th ed.. Brussels: International Diabetes Federation; 2025. 130 p. Available from: https://diabetesatlas.org
  3. Reva VB, Polovyi VP, Arshukov OV, Volianiuk KP. Varianty klinichnoho perebihu syndromu diabetychnoi stopy (naukovyi ohliad). Klin Anat Oper Khir. 2025;24(1):120-127. DOI: https://doi.org/10.24061/1727-0847.24.1.2025.16 [in Ukrainian].
  4. Conte MS, Bradbury AW, Kolh P, White JV, 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. DOI: https://doi.org/10.1016/j.jvs.2019.02.016
  5. Fitridge R, Chuter V, Mills J, Hinchliffe R, Azuma N, Behrendt CA, et al. The intersocietal IWGDF, ESVS, SVS guidelines on peripheralartery disease in people with diabetes and a foot ulcer. Diabetes Metab Res Rev. 2024;40(3):e3686. DOI: https://doi.org/10.1002/dmrr.3686
  6. Farber A, Menard MT, Conte MS, Kaufman JA, Powell RJ, Choudhry NK, et al. Surgery or Endovascular Therapy for Chronic Limb-Threatening Ischemia. N Engl J Med. 2022;387(25):2305-2316. DOI: https://doi.org/10.1056/nejmoa2207899
  7. Bradbury AW, Hall JA, Popplewell MA, Meecham L, Bate GR, Kelly L, et al. Plain versus drug balloon and stenting in severe ischaemia of the leg (BASIL-3). BMJ. 2025;388:e080881. DOI: https://doi.org/10.1136/bmj-2024-080881
  8. Falkenberg M, James S, Andersson M, Andersson M, Delle M, Engström J, et al. Paclitaxel-coated versus uncoated devices for infrainguinal endovascular revascularisation in chronic limb-threatening ischaemia (SWEDEPAD 1). Lancet. 2025;406(10508):1103-1114. DOI: https://doi.org/10.1016/S0140-6736(25)01585-5
  9. Nordanstig J, James S, Andersson M, Andersson M, Delle M, Engström J, et al. Paclitaxel-coated versus uncoated devices for infrainguinal endovascular revascularisation in patients with intermittent claudication (SWEDEPAD 2). Lancet. 2025;406(10508):1115-1127. DOI: https://doi.org/10.1016/S0140-6736(25)01584-3
  10. Barco S, Engelberger RP, Held U, Fumagalli RM, Grigorean A, Hayoz D, et al. Sirolimus-Coated Balloon Angioplasty for Infrainguinal Artery Disease. N Engl J Med. 2026;395(6):561-570. DOI: https://doi.org/10.1056/nejmoa2600360
  11. Didenko SM, Subbotin VYu, Hupalo YuM, Ratushniuk AV, Orlych OM, Haliienko LI. Khirurhichna profilaktyka trombozu zony arterialnoi rekonstruktsii u khvorykh na tsukrovyi diabet iz zahrozlyvoiu ishemiieiu nyzhnoi kintsivky. Klinichna ta profilaktychna medytsyna. 2025;(1):18-24. DOI: https://doi.org/10.31612/2616-4868.1.2025.02 [in Ukrainian].
  12. Kostiv SY, Tsiupryk NI. Revaskuliaryzatsiia infrainhvinalnoho arterialnoho rusla pry stenozo-okliuziinykh urazhenniakh z vykorystanniam endovaskuliarnykh ta hibrydnykh metodiv. Hospital Surgery. Zhurnal imeni L. Ya. Kovalchuka. 2024;(4):32-39. DOI: https://doi.org/10.11603/2414-4533.2024.4.15068 [in Ukrainian].
  13. Mazzolai L, Teixido-Tura G, Lanzi S, Boc V, Bossone E, Brodmann M, et al. 2024 ESC Guidelines for the management of peripheral arterial and aortic diseases. Eur Heart J. 2024;45(36):3538-3700. DOI: https://doi.org/10.1093/eurheartj/ehae179
  14. Schaper NC, van Netten JJ, Apelqvist J, Bus SA, Fitridge R, Game F, et al. Practical guidelines on the prevention and management of diabetes-related foot disease (IWGDF 2023 update). Diabetes Metab Res Rev. 2024;40(3):e3657. DOI: https://doi.org/10.1002/dmrr.3657
  15. Savon IL, Svyrydov MV, Holodnikov AYe, Sedoykina KV, Maksymova OO. Doslidzhennia transkutannoi napruhy kysniu v patsiientiv iz tsukrovym diabetom ta zakhvoriuvanniam peryferychnykh arterii pislia revaskuliaryzatsii nyzhnoi kintsivky dlia vyznachennia optymalnoho chasu khirurhichnoho obroblennia rany. Klinichna endokrynolohiia ta endokrynna khirurhiia. 2025;3(91):22-28. DOI: https://doi.org/10.30978/CEES-2025-3-22 [in Ukrainian].
  16. LoGerfo FW, Coffman JD. Current concepts. Vascular and microvascular disease of the foot in diabetes. Implications for foot care. N Engl J Med. 1984;311(25):1615-9. DOI: https://doi.org/10.1056/nejm198412203112506
  17. Yin J, Fu X, Luo Y, Leng Y, Ao L, Xie C. A Narrative Review of Diabetic Macroangiopathy: From Molecular Mechanism to Therapeutic Approaches. Diabetes Ther. 2024;15(3):585-609. DOI: https://doi.org/10.1007/s13300-024-01532-7
  18. Jeffcoate W, Boyko EJ, Game F, Cowled P, Senneville E, Fitridge R. Causes, prevention, and management of diabetes-related foot ulcers. Lancet Diabetes Endocrinol. 2024;12(7):472-482. DOI: https://doi.org/10.1016/s2213-8587(24)00110-4
  19. Armstrong DG, Tan TW, Boulton AJM, Bus SA. Diabetic Foot Ulcers: A Review. JAMA. 2023;330(1):62-75. DOI: https://doi.org/10.1001/jama.2023.10578
  20. Chuter V, Schaper N, Hinchliffe R, Mills J, Azuma N, Behrendt CA, et al. Performance of non-invasive bedside vascular testing in the prediction of wound healing or amputation among people with foot ulcers in diabetes. Diabetes Metab Res Rev. 2024;40(3):e3701. DOI: https://doi.org/10.1002/dmrr.3701
  21. Korosoglou G, Schmidt A, Lichtenberg M, Malyar N, Stavroulakis K, Reinecke H, et al. Global Algorithm for the Endovascular Treatment of Chronic Femoropopliteal Lesions. JACC Cardiovasc Interv. 2025;18(5):545-557. DOI: https://doi.org/10.1016/j.jcin.2024.11.038
  22. Varcoe RL, DeRubertis BG, Kolluri R, Krishnan P, Metzger DC, Bonaca MP, et al. Drug-Eluting Resorbable Scaffold versus Angioplasty for Infrapopliteal Artery Disease. N Engl J Med. 2024;390(1):9-19. DOI: https://doi.org/10.1056/NEJMoa2305637
  23. DeRubertis BG, Varcoe RL, Krishnan P, Bonaca MP. Drug-Eluting Resorbable Scaffold Versus Balloon Angioplasty for Below-the-Knee Peripheral Artery Disease: 2-Year Results From the LIFE-BTK Trial. Circulation. 2025;152(15):1076-1086. DOI: https://doi.org/10.1161/circulationaha.125.075080
  24. Katsanos K, Spiliopoulos S, Kitrou P, Krokidis M, Karnabatidis D. Risk of Death Following Application of Paclitaxel-Coated Balloons and Stents in the Femoropopliteal Artery of the Leg. J Am Heart Assoc. 2018;7(24):e011245. DOI: https://doi.org/10.1161/JAHA.118.011245
  25. U.S. Food and Drug Administration. UPDATE: Paclitaxel-coated devices to treat peripheral arterial disease unlikely to increase risk of mortality: letter to health care providers. Silver Spring (MD): U.S. Food and Drug Administration; 2023. Available from: https://www.fda.gov/medical-devices/letters-health-care-providers/update-paclitaxel-coated-devices-treat-peripheral-arterial-disease-unlikely-increaserisk-mortality
  26. Katsanos K, Spiliopoulos S. Paclitaxel in the lower limbs: harm outweighs the benefit. Lancet. 2025;406(10508):1064-1065. DOI: https://doi.org/10.1016/S0140-6736(25)01684-8
  27. Shishehbor MH, Powell RJ, Montero-Baker MF, Dua A, Martínez-Trabal JL, Bunte MC, et al. Transcatheter Arterialization of Deep Veins in Chronic Limb-Threatening Ischemia. N Engl J Med. 2023;388(13):1171-1180. DOI: https://doi.org/10.1056/NEJMoa2212754
  28. U.S. Food and Drug Administration. LimFlow™ System – P220025. Silver Spring (MD): U.S. Food and Drug Administration; 2023. Available from: https://www.fda.gov/medical-devices/recently-approved-devices/limflowtm-system-p220025
  29. Kofiah Y. Outcomes of intravascular lithotripsy for calcified femoropopliteal and infrapopliteal artery disease. Medicine (Baltimore). 2026;105(19):e48691. DOI: https://doi.org/10.1097/MD.0000000000048691
  30. Tepe G, Brodmann M, Werner M, Bachinsky W, Holden A, Zeller T, et al. Intravascular Lithotripsy for Peripheral Artery Calcification: 30-Day Outcomes From the Randomized Disrupt PAD III Trial. JACC Cardiovasc Interv. 2021;14(12):1352-1361. DOI: https://doi.org/10.1016/j.jcin.2021.04.010
  31. Limus Drug Eluting Balloon Versus Standard Balloon Angioplasty for Treatment of Infrapopliteal Arterial Occlusions (LIMES). Bethesda (MD): National Library of Medicine (US); 2021. Available from: https://clinicaltrials.gov/study/NCT04772300
  32. FUTURE-BTK: Sirolimus-Coated Balloon Versus Standard Balloon Angioplasty in Below-the-Knee Arteries. Bethesda (MD): National Library of Medicine (US); 2020. Available from: https://clinicaltrials.gov/study/ NCT04511247
  33. Palena LM, Saad PF, Piccolo E, Gabellini T, Baldazzi G, Ciofani L, et al. Below-the-Ankle Orbital Atherectomy in Chronic Limb-Threatening Ischemia Patients as a Bailout Strategy for Limb Salvage. Cardiovasc Revasc Med. 2022;42:121-126. DOI: https://doi.org/10.1016/j.carrev.2022.03.015
  34. Bradbury AW, Moakes CA, Popplewell M, Meecham L, Bate GR, Kelly L, et al. A vein bypass first versus a best endovascular treatment first revascularisation strategy for patients with CLTI who required an infra-popliteal, with or without an additional more proximal infra-inguinal revascularisation procedure to restore limb perfusion (BASIL-2). Lancet. 2023;401(10390):1798-1809. DOI: https://doi.org/10.1016/S0140-6736(23)00462-2
  35. Mills JL Sr, Conte MS, Armstrong DG, Pomposelli FB, Schanzer A, Sidawy AN, et al. The Society for Vascular Surgery Lower Extremity Threatened Limb Classification System: risk stratification based on wound, ischemia, and foot infection (WIfI). J Vasc Surg. 2014;59(1):220-34.e1-2. DOI: https://doi.org/10.1016/j.jvs.2013.08.003
  36. Powell RJ, Farber A, Doros G, Chew D, Conte MS, Dake MD, et al. The Incidence and Consequences of Endovascular Technical Failure in Patients with Chronic Limb-Threatening Ischemia: Results from the Best Endovascular versus Best Surgical Therapy in Patients with Critical Limb-Threatening Ischemia (BEST-CLI) Trial. J Vasc Interv Radiol. 2025;36(6):950-959. DOI: https://doi.org/10.1016/j.jvir.2025.02.020
  37. Sun X, Zhang C, Ma Y, He Y, Zhang X, Wu J. Association between diabetes mellitus and primary restenosis following endovascular treatment. Cardiovasc Diabetol. 2024;23(1):132. DOI: https://doi.org/10.1186/s12933-024-02201-6
  38. Tarricone A, Gee A, de la Mata K, Rogers L, Wiley J, Lavery LA, et al. Outcomes for Patients With Chronic Limb-Threatening Ischemia After Direct and Indirect Endovascular and Surgical Revascularization. J Endovasc Ther. 2026;33(1):56-63. DOI: https://doi.org/10.1177/15266028241248524
  39. Srinivasan A, Miranda J, Mills JL. Appropriate care in chronic limb threatening ischemia: A review of current evidence and outcomes. Semin Vasc Surg. 2024;37(2):249-257. DOI: https://doi.org/10.1053/j.semvascsurg.2024.04.001
  40. Gornik HL, Aronow HD, Goodney PP, Arya S, Brewster LP, Byrd L, 2024 ACC/AHA/AACVPR/SCAI/SVM/SVN/SVS/SIR/VESS Guideline for the Management of Lower Extremity Peripheral Artery Disease. Circulation. 2024;149(24):e1313-e1410. DOI: https://doi.org/10.1161/CIR.0000000000001251
  41. Chen Z, Tan TW, Zhao Y, Jiang C, Zeng Q, Fan G, et al. WIfI Classification Based Analysis of Risk Factors for Outcomes in Patients with Chronic Limb Threatening Ischaemia after Endovascular Revascularisation Therapy. Eur J Vasc Endovasc Surg. 2023;65(4):528-536. DOI: https://doi.org/10.1016/j.ejvs.2022.12.027
  42. Morisaki K, Matsubara Y, Yoshino S, Kurose S. Validation of the GLASS Staging Systems in Patients With Chronic Limb-Threatening Ischemia Undergoing De Novo Infrainguinal Revascularization. Ann Vasc Surg. 2022;81:378-386. DOI: https://doi.org/10.1016/j.avsg.2021.09.054
  43. Li B, Verma R, Beaton D, Tamim H, Hussain MA, Hoballah JJ, et al. Predicting outcomes following lower extremity open revascularization using machine learning. Sci Rep. 2024;14(1):2899. DOI: https://doi.org/10.1038/s41598-024-52944-1
  44. Al-Juhani A, Desoky R, Abdullah A, Younes E, Khoja S, Aljohani SS, et al. Machine Learning in Predicting Wound Healing and Limb Salvage Outcomes Following Lower Limb Revascularization: A Systematic Review of Prognostic Accuracy. Cureus. 2025;17(7):e88568. DOI: https://doi.org/10.7759/cureus.88568
  45. Callegari S, Romain G, Cleman J, Scierka L, Jacque F. Long-Term Mortality Predictors Using a Machine-Learning Approach in Patients With CLTI After Peripheral Vascular Intervention. J Am Heart Assoc. 2024;13(10):e034477. DOI: https://doi.org/10.1161/JAHA.124.034477

Publication of the article:

«Bulletin of problems biology and medicine», 2026 Issue 3, 182, 31-39 pages, index UDC 616.137-005.4-089.819:616.379-008.64

DOI:

10.29254/2077-4214-2026-3-182-31-39

2026 Issue 3, 182
chronic limb-threatening ischemia diabetes mellitus drug-coated balloon endovascular revascularization limb salvage
29.09.2026
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