OBJECTIVES

In patients with early stages of critical limb ischemia (CLI) (i.e., Rutherford-4/Fontaine-III), conservative treatment by pharmacotherapies is often the preferred strategy despite the suitability and availability of endovascular interventions as alternative. We compare the cost-effectiveness of timely intervention by bare-metal stent vs. delayed intervention using pharmacological treatment-only, from the German healthcare system perspective.

METHODS :

A Markov model, with a five-year time-horizon, was developed with a total of seven states: intervention, stable (no further treatment required), major amputation, re-intervention, comfort care (no re-intervention possible), and all-cause death. The intervention state consisted of a stent in one arm and of conservative treatment in the other. The re-intervention state consisted of a first or second stent intervention in either arm respectively. Transition probabilities were obtained from a systematic search of clinical studies. Intervention and disease related costs were estimated from data provided by German Diagnosis-Related Groups (aG-DRG) and the Federal Statistical Office (Destatis). Health-state utilities were obtained from literature.

Primary outcomes were quality-adjusted life years (QALYs), costs, and incremental cost-effectiveness ratios (ICERs).

Scenario analysis was performed with three re-intervention states within one cycle versus only one re-intervention in the base case scenario. Costs and QALYs were discounted at 3%. Analyses were performed in software R- heemod package.

RESULTS

In the base case, timely endovascular intervention resulted in an incremental cost of 4,117 € with 1.15 additional QALYs per patient. ICER for the base case is therefore 3,582 €/QALY. In three re-interventions scenario, the incremental cost was 3,987 € and additional QALYs 1.13 per patient, resulting in an ICER of 3,523 €/QALY.

CONCLUSIONS

When compared with a delay by conservative treatment, timely intervention with bare-metal stent has proven to be cost-effective in early-stage CLI patients. Comprehensive micro-level disease costs and sensitivity analyses will provide further insights on the current preliminary findings.