Cost-utility analysis of early versus delayed endovascular intervention in critical limb-threatening ischemia patients with rest pain.

Objective: The prevalence of chronic limb-threatening ischemia (CLTI) and poor health outcomes are high in Germany. Serious consequences of CLTI such as amputation and mortality can be effectively prevented by the early use of evidence-based therapeutic measures such as endovascular intervention. We have developed a cost-utility analysis to compare endovascular intervention with bare metal stents (BMSs) and endovascular intervention after conservative treatment from the German payer perspective.

Methods: A Markov model, with a 5-year time horizon and seven states, was developed: (1) intervention, (2) stable 1, (3) major amputation, (4) reintervention, (5) stable 2, (6) care, and (7) all-cause death. Transition probabilities were obtained by pooling the outcomes from multiple clinical studies. The costs were estimated using data from the German diagnosis-related group system, the German rehabilitation fund, and related literature. Health-state utilities were obtained from the reported data. The primary outcomes were the quality-adjusted life-years (QALYs) and costs.

Results: Early BMS intervention after 5 years resulted in a cost of €23,913 and an increase of 2.5 QALYs per patient, and endovascular intervention with BMS after conservative treatment after 5 years resulted in a cost of €18,323 and an increase of 2 QALYs per patient. The incremental cost-effectiveness ratio was €12,438. The number of major amputations was reduced by 6%. The results of the structural, deterministic, and probabilistic sensitivity analyses were robust.

Conclusions: Early endovascular intervention with BMS resulted in more QALYs and a reduced risk of major amputation for early-stage CLTI patients. Our results showed that early endovascular intervention is very cost-effective according to World Health Organization recommended cost-effectiveness thresholds. However, the clinical decision regarding the use of early endovascular intervention should be determined by individual patient-level eligibility and the physician's judgment.