Impact of Frailty on Clinical Outcomes in Patients With Critical Limb Ischemia.

Abstract

The predictive ability of patient frailty on clinical outcomes after revascularization in patients with critical limb ischemia remains largely unknown. 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. 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.