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

Background For patients with critical limb ischaemia, spinal-cord stimulati on has been advocated for the treatment of ischaemic pain and the preventio n of amputation. We compared the efficacy of the addition of spinal-cord st imulation 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 ad dition to best medical treatment or best medical treatment alone. Primary o utcomes were mortality and amputation. The primary endpoint was limb surviv al at 2 years. Findings The mean (SD) age of the patients was 72.6 years (10.3). Median (I QR) follow-up was 605 days (244-1171). 40 (67%) of 60 patients in the spina l-cord-stimulator group and 41 (68%) of 60 patients in the standard group w ere alive at the end of the study, (p=0.96). There were 25 major amputation s in the spinal-cord-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 (9 5% CI 0.61-1.51). Interpretation Spinal-cord-stimulation in addition to best medical care doe s not prevent amputation in patients with critical limb ischaemia.