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.