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Impact of Frailty on Clinical Outcomes in Patients With Critical Limb Ischemia. BACKGROUND: The predictive ability of patient frailty on clinical outcomes after revascularization in patients with critical limb ischemia remains largely unknown. METHODS AND RESULTS: We enrolled 643 patients with critical limb ischemia treated with endovascular therapy (N=486) or bypass surgery (N=157) in January 2010 to January 2016, and prospectively assessed them using a 9-level clinical frailty scale (CFS). Patients were divided into 3 groups according to CFS levels: low (CFS level, 1-3; N=234), intermediate (CFS level, 4-6; N=196), and high (CFS level, 7-9; N=213) groups. Clinical follow-up rate was 95.8% at 2 years. In the low, intermediate, and high CFS groups, 2-year overall survival rates were 80.5%, 63.1%, and 49.3% (P<0.001) and amputation-free survival rates were 77.9%, 60.5%, and 46.2% (P<0.001), respectively. In multivariable analysis, higher frailty was independently associated with all-cause death (intermediate CFS group: adjusted hazard ratio, 1.64; 95% confidence interval, 1.12-2.42; P=0.01; high CFS group: adjusted hazard ratio, 2.22; 95% confidence interval, 1.52-3.23; P<0.001) and a composite of all-cause death and major amputation (intermediate CFS group: adjusted hazard ratio, 1.72; 95% confidence interval, 1.19-2.48; P=0.004; high CFS group: adjusted hazard ratio, 2.34; 95% confidence interval, 1.64-3.35; P<0.001). Frailty was also independently associated with overall survival and amputation-free survival in patients aged ≤75 and >75 years, those who underwent endovascular therapy or bypass surgery, and those with or without chronic renal failure, without significant interactions. CONCLUSIONS: Frailty was independently associated with 2-year overall survival and amputation-free survival in patients with critical limb ischemia treated with revascularization, irrespective of age, revascularization mode, and chronic renal failure status.