Outcome in patients with critical limb ischemia in the ESES-trial : spinal cord stimulation versus optimal medical treatment

textabstractThere has been a long history of interest in the effects of spinal cord stimulation (SCS) for critical limb ischemia (CLI), especially if meaningful revascularisation is not possible. In a randomized trial (ESES-trial), we compared two treatment regimens (best medical treatment and best medical treatment plus SCS). We did not find that spinal-cord stimulation was of benefit above that of best medical treatment. Amputation-free survival was not improved (p=0.86). The rates of amputation were similar in both groups (p=0.47) and were particularly high during the first 3 months.Quality of life showed poor scores compared with matched reference values of the general population, but there were no significant differences between the randomized treatment group during treatment. Although patients with a spinal-cord stimulator used significantly less pain medication (suggesting substantial pain relief from this treatment), similar pain reduction was seen in the medical and SCS-treatment groups. Over two years, the costs of SCS-treatment were higher as compared to best medical treatment alone (€36,600 vs. €28,700, p=0.009)