Work

Prognostic performance of the WIfI classification in diabetic patients with infrapopliteal CLTI after endovascular revascularization: a subgroup analysis of the PRIME-WIFI registry

Year: 2026

Type: article

Abstract: Background The Wound, Ischemia, and foot Infection (WIfI) classification is widely used to stratify amputation risk in chronic limb-threatening ischemia (CLTI). However, its prognostic performance in diabetic patients after endovascular revascularization remains unclear. This study aimed to assess the predictive value of WIfI in this population. Methods This subgroup analysis was derived from the prospective, multicenter PRIME-WIFI registry. Diabetic patients with infrapopliteal CLTI who underwent endovascular revascularization were included. Baseline WIfI stage was assessed prior to intervention. The primary endpoint was major adverse events (MAE), defined as all-cause mortality, major amputation, or clinically driven target-limb reintervention (CD-TLR). Secondary endpoints included amputation-free survival (AFS), overall survival, major amputation, CD-TLR, and clinical improvement (≥ 1-category Rutherford improvement). Time-to-event outcomes were analyzed using Kaplan–Meier methods and multivariable Cox regression, with Firth’s penalized Cox regression applied when appropriate. Results A total of 707 diabetic patients (730 limbs) were analyzed; the 12-month loss-to-follow-up rate was 17.67%. One-year freedom from MAE decreased across WIfI stages (89.5%, 77.4%, 78.0%, and 70.1% for stages 1–4; log-rank P = 0.004), and WIfI stage independently predicted MAE (HR per stage, 1.33; P = 0.0011). One-year AFS was 94.7%, 83.3%, 83.3%, and 74.2% (log-rank P = 0.0003), with higher WIfI stage associated with worse AFS (HR, 1.55; P < 0.001). Overall survival was 94.7%, 87.8%, 86.1%, and 80.3% (log-rank P = 0.009), and WIfI stage was independently associated with mortality (HR, 1.46; P = 0.0012). Freedom from major amputation was 100.0%, 95.3%, 96.8%, and 92.3% (log-rank P = 0.02), with higher WIfI stage independently associated with major amputation (HR, 1.67; P = 0.012). In contrast, freedom from CD-TLR did not differ significantly across stages (log-rank P = 0.60; HR, 0.97; P = 0.832). Clinical improvement tended to decrease with increasing WIfI stage but did not reach statistical significance (P = 0.053). Conclusions In this diabetic subgroup, WIfI classification provides meaningful risk stratification for MAE, AFS, mortality, and major amputation. However, its discriminative ability is most pronounced by stage 1 and stage 4, with limited separation between intermediate stages. These findings support the continued use of WIfI for risk stratification in diabetic infrapopliteal disease while highlighting reduced differentiation between stages 2 and 3. Trial registration ClinicalTrials.gov identifier NCT04710420 (registered on 20210114).

Source: Frontiers in Cardiovascular Medicine

DOI: 10.3389/fcvm.2026.1984270