Spinal-cord stimulation in critical limb ischaemia: a randomised trial

Background For patients with critical limb ischaemia, spinal-cord stimulation has been advocated for the treatment of ischaemic pain and the prevention of amputation. We compared the efficacy of the addition of spinal-cord stimulation to best medical treatment in a randomised controlled trial. Methods 120 patients with critical limb ischaemia not suitable for vascular reconstruction were randomly assigned either spinal-cord stimulation in addition to best medical treatment or best medical treatment alone. Primary outcomes were mortality and amputation. The primary endpoint was limb survival at 2 years. Findings The mean (SD) age of the patients was 72·6 years (10·3). Median (IQR) follow-up was 605 days (244–1171). 40 (67%) of 60 patients in the spinal-cordstimulator group and 41 (68%) of 60 patients in the standard group were alive at the end of the study, (p=0·96). There were 25 major amputations in the spinalcord-stimulator group and 29 in the standard group, (p=0·47). The hazard ratio for survival at 2 years without major amputation in the spinal-cord stimulation group compared with the standard group was 0·96 (95% CI 0·61–1·51). Interpretation Spinal-cord-stimulation in addition to best medical care does not prevent amputation in patients with critical limb ischaemia.