Optimization of Endovascular Strategy Selection in Patients With Diabetes Mellitus and Critical Limb Ischemia: From Evidence to the Plan Algorithm

Q: What is the clinical evidence from this study?

Study design: Review. Population: Diabetes mellitus and chronic limb-threatening ischemia. Intervention: Endovascular revascularization (sirolimus-coated balloons and paclitaxel-coated devices) vs. Standard balloon angioplasty. Primary outcome: Amputation-free survival, limb salvage, and need for repeat revascularization.

Q: What does this research mean for the field?

Prolonged war-related stress exacerbates declines in the quality of life of patients with chronic heart failure by compounding psychological distress, functional decline, and social disruption. Novelty: ClaimNovelty.SYNTHESIS. Consensus alignment: ConsensusAlignment.NEUTRAL.

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

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

January 1, 2026Bulletin of Problems Biology and MedicineOpen Access

Optimization of Endovascular Strategy Selection in Patients With Diabetes Mellitus and Critical Limb Ischemia: From Evidence to the Plan Algorithm

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Key result

Sirolimus-coated balloons emerge as top endovascular option in diabetic CLTI, outperforming paclitaxel and standard angioplasty.

Why the study?

The impact of prolonged war-related stress on quality of life, functional capacity, and psychoemotional state in patients with chronic heart failure was not well characterized.

Do modern endovascular strategies improve limb salvage and amputation-free survival in patients with diabetes mellitus and chronic limb-threatening ischemia?

Key Points

To synthesize 2016–2026 evidence on endovascular revascularization in patients with diabetes mellitus and chronic limb-threatening ischemia, compare randomized trial results with guidelines, and establish a strategy selection framework based on the PLAN sequence.
Conducted a structured narrative literature review of publications from 2016 to 2026 across PubMed/MEDLINE, Scopus, Web of Science Core Collection, and the Cochrane Library.
Applied PRISMA 2020 reporting criteria and reviewed trial registries and societal guidelines (ESVS, ESC, ACC/AHA, IWGDF), incorporating 45 sources into the final qualitative analysis.
In the BASIL-3 and SWEDEPAD 1 trials, paclitaxel-eluting devices demonstrated no statistically significant advantages in amputation-free survival or reduction in major amputations compared with standard balloon angioplasty.
Device selection in the PLAN algorithm is determined by clinical risk and limb threat severity, with major amputation risk after revascularization increasing from 0% in WIfI stage I to 38% in stage IV.

Structured PICO

Do modern endovascular strategies improve limb salvage and amputation-free survival in patients with diabetes mellitus and chronic limb-threatening ischemia?

P

Population

A structured narrative review of 45 publications evaluating endovascular revascularization strategies in patients with diabetes mellitus and chronic limb-threatening ischemia.

I

Intervention

Endovascular revascularization strategies (including paclitaxel- and sirolimus-coated devices, intravascular lithotripsy, and deep vein arterialization)

C

Comparator

Standard balloon angioplasty or bare-metal stents

O

Outcome

Limb salvage, amputation-free survival, and need for repeat revascularizationhard clinical

The review highlights a shift in endovascular therapy for diabetic CLTI from focusing on vessel patency to prioritizing clinical endpoints like limb salvage, with sirolimus-coated devices showing emerging benefits.

Limitations

Lack of external validation for machine learning models in European and Ukrainian populations
Absence of a national registry for endovascular interventions in Ukraine
Heterogeneity of included studies regarding populations, design, and endpoints prevented quantitative synthesis
Lack of national registry and population data in Ukraine
Lack of external validation for machine learning models

Implication

Sirolimus-coated balloons may warrant preference in diabetic CLTI; extends comparative endovascular evidence while challenging paclitaxel use.

Abstract

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Discussion

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Cite This Study

Hmoshynskyi et al. (2026) conducted a review in Diabetes mellitus and chronic limb-threatening ischemia. Endovascular revascularization (sirolimus-coated balloons and paclitaxel-coated devices) vs. Standard balloon angioplasty was evaluated on Amputation-free survival, limb salvage, and need for repeat revascularization. Sirolimus-coated balloons appear to be the most promising endovascular option for patients with diabetes and chronic limb-threatening ischemia, whereas paclitaxel-coated devices showed no advantage over standard angioplasty.

synapsesocial.com/papers/6ac2fd227180a622ddd4dff1 https://doi.org/10.29254/2077-4214-2026-3-182-31-39

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Optimization of Endovascular Strategy Selection in Patients With Diabetes Mellitus and Critical Limb Ischemia: From Evidence to the Plan Algorithm

Key Points

Structured PICO

Limitations

Implication

Abstract

Discussion

Cite This Study

Optimization of Endovascular Strategy Selection in Patients With Diabetes Mellitus and Critical Limb Ischemia: From Evidence to the Plan Algorithm

Key Points

Structured PICO

Limitations

Implication

Abstract

Discussion

Cite This Study

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