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Clinical Trial
, 353 (9158), 1040-4

Spinal-cord Stimulation in Critical Limb Ischaemia: A Randomised Trial. ESES Study Group

Affiliations
Clinical Trial

Spinal-cord Stimulation in Critical Limb Ischaemia: A Randomised Trial. ESES Study Group

H M Klomp et al. Lancet.

Abstract

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-cord-stimulator 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 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 (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.

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