Twelve-month outcomes of drug-coated balloon treatment for infrapopliteal chronic limb-threatening ischemia in the PRIME-WIFI study subgroup analysis

This study aims to evaluate the 12-month clinical outcomes of drug-coated balloon (DCB) treatment for infrapopliteal chronic limb-threatening ischemia (CLTI) in a real-world setting, and to provide evidence to inform clinical decision-making. Based on the PRIME-WIFI multicenter prospective registry, 538 patients (553 limbs) from 10 centers were consecutively enrolled between December 2020 and June 2023. All patients underwent infrapopliteal DCB angioplasty and were included in the 12-month outcome analysis. The primary endpoint was the freedom from major adverse events (MAE), including major amputation, all-cause mortality, and clinically driven target limb reintervention (CD-TLR). Secondary endpoints included amputation-free survival (AFS), sustained clinical improvement, and quality of life. The Kaplan–Meier method was used to estimate event rates, and Cox regression was applied to identify independent predictors of 12-month MAE. The 12-month MAE-free rate was 75.5%, AFS was 82.2%, major amputation-free rate was 95.9%, all-cause mortality-free rate was 85.7%, and CD-TLR-free rate was 91.4%. 58.4% of limbs showed sustained clinical improvement, with significant wound and infection improvement ( p < 0.001). Multivariate Cox regression revealed that BMI (HR 0.91, p = 0.004) and WIfI stage (HR 1.245, p = 0.042) were independent predictors of MAE. In this single-arm, real-world observational cohort, infrapopliteal DCB treatment was associated with acceptable 12-month clinical outcomes. Trial Registration ClinicalTrials.gov, NCT04710420, registered on January 8, 2021