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Lancet. 1999 Mar 27;353(9158):1040-4.

Spinal-cord stimulation in critical limb ischaemia: a randomised trial. ESES Study Group.

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1
Department of Surgery, University Hospital Rotterdam-Dijkzigt, Rotterdam, The Netherlands.

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.

PMID:
10199350
[Indexed for MEDLINE]
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