Spinal-cord stimulation in critical limb ischaemia: a randomised trial. ESES Study Group.
Lancet
; 353(9158): 1040-4, 1999 Mar 27.
Article
em En
| MEDLINE
| ID: mdl-10199350
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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Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Medula Espinal
/
Terapia por Estimulação Elétrica
/
Isquemia
/
Perna (Membro)
Tipo de estudo:
Clinical_trials
/
Etiology_studies
/
Health_economic_evaluation
/
Risk_factors_studies
Limite:
Aged
/
Female
/
Humans
/
Male
Idioma:
En
Revista:
Lancet
Ano de publicação:
1999
Tipo de documento:
Article
País de afiliação:
Holanda