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. 2025 Jun 5;13(6):1384.
doi: 10.3390/biomedicines13061384.

Real-World Efficacy of Minimally Invasive Revascularization in Diabetic Foot Ischemia: Impact of Device Selection and Lesion-Specific Factors

Yue Lin  1 , Fanzhen Lv  1 , Yulong Huang  1 , Gang Chen  1 , Shichai Hong  1 , Xiang Hong  1 , Xinsheng Xie  1 , Weifeng Lu  1 , Weiguo Fu  1   2
Affiliations

Real-World Efficacy of Minimally Invasive Revascularization in Diabetic Foot Ischemia: Impact of Device Selection and Lesion-Specific Factors

Yue Lin et al. Biomedicines. .

Abstract

Objectives: The objective of this study was to evaluate the real-world efficacy of minimally invasive revascularization in diabetic foot ischemia, focusing on novel insights into device selection and lesion-specific predictors. Methods: This retrospective study included 98 patients (101 limbs) undergoing endovascular/hybrid interventions. The primary endpoints were 1- and 2-year primary patency and freedom from clinically driven target lesion revascularization (CD-TLR). Multivariate Cox regression identified restenosis predictors, with subgroup analysis comparing drug-coated devices (DCDs) versus conventional strategies in chronic limb-threatening ischemia (CLTI). Results: The cohort (mean age 72.1 ± 8.9 years) comprised 51% CLTI limbs (28.5% with tissue loss). The overall 1-year primary patency was 75.6%, declining to 67.6% after 2 years. The rates of freedom from CD-TLR were 87.4% after 1 year and 74.8% after 2 years. CLTI was associated with significantly reduced 1-year (66.5% vs. 84.9%) and 2-year primary patency (56.3% vs. 80.1%; log-rank p = 0.026) compared to non-CLTI. Multivariate analysis identified CLTI as an independent predictor of restenosis (HR 3.375, 95%CI 1.267-8.990, p = 0.015). Although DCDs did not improve 2-year primary patency in CLTI (58.5% vs. 57.3%, p = 0.768), they demonstrated superior 2-year CD-TLR-free survival (78.5% vs. 54.6%, p = 0.048). The total complication rate was 5.9%, with no significant difference between CLTI and non-CLTI groups (11.5% vs. 0%, p = 0.057). Conclusions: This study highlights CLTI's impact on revascularization durability and the clinical benefits of DCDs in reducing reinterventions, offering evidence-based insights for tailored device selection despite retrospective limitations.

Keywords: CLTI; PAD; diabetic foot ischemia; patency; revascularization.

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Conflict of interest statement

The authors declare no conflicts of interest.

Figures

Figure 1
Figure 1
Kaplan–Meier curve showing two-year primary patency rates for all lesions (n = 101) in patients with diabetic foot ischemia. Primary patency was 75.6% at 1 year and 67.6% at 2 years.
Figure 2
Figure 2
Kaplan–Meier curve illustrating two-year freedom from clinically driven target lesion revascularization (CD-TLR) for all lesions (n = 101). Freedom from CD-TLR was 87.4% at 1 year and 74.8% at 2 years.
Figure 3
Figure 3
Kaplan–Meier curve comparing two-year primary patency rates between non-CLTI and CLTI groups. Non-CLTI patients had significantly higher patency (84.9% vs. 66.5% at 1 year; 80.1% vs. 56.3% at 2 years, log-rank p = 0.026).
Figure 4
Figure 4
Kaplan–Meier curve comparing two-year freedom from CD-TLR between non-CLTI and CLTI groups. Non-CLTI patients had higher CD-TLR-free survival (93.4% vs. 79.3% at 1 year; 85.7% vs. 65.6% at 2 years, log-rank p = 0.035).
Figure 5
Figure 5
Subgroup analysis: Kaplan–Meier curve comparing two-year primary patency rates in CLTI patients with versus without drug-coated devices (DCDs). Patency rates were similar (68.7% vs. 67.8% at 1 year; 58.5% vs. 57.3% at 2 years, log-rank p = 0.768).
Figure 6
Figure 6
Subgroup analysis: Kaplan–Meier curve comparing two-year freedom from CD-TLR in CLTI patients with versus without DCDs. DCD use was associated with improved CD-TLR-free survival (90.2% vs. 69.4% at 1 year; 78.5% vs. 54.6% at 2 years, log-rank p = 0.048).
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