Advanced Wound, Ischemia, and Foot Infection stage is associated with poor outcomes in the BEST-CLI trial.

Objective: Wound, Ischemia, and foot Infection (WIfI) staging was established to provide objective classification in patients with chronic limb-threatening ischemia (CLTI) and to predict 1-year major amputation risk. Our goal was to validate WIfI staging using data from the Best Endovascular vs Best Surgical Therapy in Patients with CLTI (BEST-CLI) trial.

Methods: Data from the BEST-CLI Trial, a prospective randomized trial comparing surgical revascularization (OPEN) and endovascular revascularization (ENDO), were used to assess the association of WIfI stage on long-term outcomes in an intention-to-treat analysis. Patients were prospectively allocated to two cohorts, which included patients with and without adequate single-segment greater saphenous vein, respectively. The primary outcome of this analysis was major amputation.

Results: There were 1568 patients analyzed, representing 86% of the entire trial population; of these 35.5%, 29.6%, and 34.9% were categorized as WIfI stage 4, WIfI stage 3, and WIfI stage 1/2, respectively. There were 1223 patients (606 OPEN, 617 ENDO) and 345 patients (OPEN 172, ENDO 173) in cohorts 1 and 2, respectively. On unadjusted Kaplan-Meier analysis, WIfI clinical stages 4 and 3, compared with WIfI stage 1/2, were associated with higher rates of major amputation (21.4%, 16.2% vs 10.7%), death (33.5%, 35.7% vs 24.6%), amputation/death (44.9%, 44.5% vs 31.3%), major adverse limb events (MALEs)/death (34.4%, 33.9% vs 29.5%), and reintervention/amputation/death (69.9% vs 69% vs 60.4%) (P < .05 for all) at 3 years. On risk-adjusted analysis, compared with WIfI stage 1/2, major amputation was associated with WIfI stage 4 (hazard ratio [HR], 2.06; 95% confidence interval [CI], 1.44-2.96; P < .001) and WIfI stage 3 (HR, 1.62; 95% CI, 1.1-2.37; P = .013) stages. Death was associated with WIfI stage 4 (HR, 1.3; 95% CI, 1.03-1.63; P = .027) and WIfI stage 3 (HR, 1.42; 95% CI, 1.13-1.79; P = .003). MALE/death was associated with WIfI stage 4 (HR, 1.29; 95% CI, 1.02-1.63; P = .036. Reintervention amputation/death was associated with WIfI stage 4 (HR, 1.28; 95% CI, 1.09-1.50; P = .03) and WIfI stage 3 (HR, 1.22, 99% CI 1.03-1.43) ; P = .018). When examining OPEN vs ENDO revascularization by each WIfI stage, OPEN intervention was favored in cohort 1 for MALE/death for each stage.

Conclusions: In BEST-CLI, WIfI stage was strongly associated with major amputations, death, and MALEs/death after revascularization for CLTI. Cohort 1 patients, with an adequate preoperative single segment greater saphenous vein, had lower MALE/death with OPEN intervention across all WIfI stages. This validation of WIfI score in a prospective multicenter trial reinforces its importance in shared-decision making, informed consent, and prognostication.