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


RESULTS
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).


CONCLUSIONS
Spinal-cord-stimulation in addition to best medical care does not prevent amputation in patients with critical limb ischaemia.
Klomp
H M
HM
Department of Surgery, University Hospital Rotterdam-Dijkzigt, Rotterdam, The Netherlands.
Spincemaille
G H
GH
Steyerberg
E W
EW
Habbema
J D
JD
van Urk
H
H
D000368:Aged; D000671:Amputation, Surgical / Q000706:statistics & numerical data; D003365:Costs and Cost Analysis; D004599:Electric Stimulation Therapy / Q000009:adverse effects; D005260:Female; D006801:Humans; D007511:Ischemia / Q000188:drug therapy / Q000401:mortality / Q000628:therapy*; D007866:Leg / Q000098:blood supply*; D008297:Male; D009294:Narcotics / Q000627:therapeutic use; D010146:Pain / Q000188:drug therapy; D010147:Pain Measurement; D012016:Reference Values; D012307:Risk Factors; D013116:Spinal Cord; D016019:Survival Analysis
D009294:Narcotics