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 versus Best Surgical Therapy in Patients with CLTI (BEST-CLI) trial. Data from the BEST-CLI Trial, a prospective randomized trial comparing surgical (OPEN) and endovascular (ENDO) revascularization, 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 - cohort 1 and 2 - which included patients with and without adequate single segment greater saphenous vein (SSGSV), respectively. The primary outcome of this analysis was major amputation. There were 1,568 patients analyzed, representing 86% of the entire trial population; of these 35.5%, 29.6% and 34.9% were categorized as WIfI 4, WIfI 3, and WIfI 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 to WIfI 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%), MALE/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 to WIfI 1/2, major amputation was associated with WIfI 4 (HR 2.06, 95% CI 1.44 - 2.96, P<.001) and WIfI 3 (HR 1.62, 95% CI 1.1-2.37, P=.013) stages. Death was associated with both WIfI 4 (HR 1.3, 95% CI 1.03 - 1.63, P=.027) and WIfI 3 (HR 1.42, 95% CI 1.13-1.79, P=.003). MALE/death was associated with WIfI 4 (HR 1.29, 95% CI 1.02 - 1.63, P=.036. Reintervention amputation/death was associated with WIfI 4 (HR 1.28, 95% CI 1.09 - 1.50, P=.03) and WIfI 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. In BEST-CLI WIfI stage was strongly associated with major amputations, death, and MALE/death after revascularization for CLTI. Cohort 1 patients, with adequate preoperative SSGSV, 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.
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