Objective To quantify the costs of treatment in critical limb ischaemia (CLI) and to compare costs and effectiveness of two treatment strategies: spinal cord stimulation (SCS) and best medical treatment. Methods One hundred and twenty patients with CLI not suitable for vascular reconstruction were randomised to either SCS in addition to best medical treatment or best medical treatment alone. Primary outcomes were mortality, amputation and cost. Cost analysis was based on resources used by patients for 2 years after randomisation. Both medical and non-medical costs were included. Results Patient and limb survival were similar in the two treatment groups. Costs of in-hospital-stay and institutional rehabilitation constituted the predominant part (±70%) of the total costs of medical care in CLI. Cost of SCS-implantation and complications (€7950 per patient) exceeded by far cost due to amputation procedures (€410 per patient). The total costs of treatment were €36,600 per patient over 2 years for the SCS-group vs. €28,700 for best medical treatment alone (28% higher for SCS-group, p=0.009). Conclusions Total costs of treatment in CLI are high. Major components are hospital and rehabilitation costs. In contrast to recent reviews, there were no long-term benefits of SCS-treatment. Therefore, cost-effectiveness is reduced to cost-minimisation and SCS-treatment is considerably more expensive than best medical treatment.
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