Cost-Effectiveness of Drug-Eluting Stents for Infrapopliteal Lesions in Patients with Critical Limb Ischemia: The PADI Trial

Purpose: Drug-eluting stents (DES) improve clinical and morphological long-term results compared to percutaneous transluminal angioplasty (PTA) with bailout bare metal stenting (BMS) in patients with critical limb ischemia (CLI) and infrapopliteal lesions (PADI trial). We performed a cost-effectiveness analysis of DES compared to PTA ± BMS in cooperation with Dutch health insurance company VGZ, using data from the PADI trial. Materials and Methods: In the PADI trial, adults with CLI (Rutherford category ≥ 4) and infrapopliteal lesions were randomized to receive DES with paclitaxel or PTA ± BMS. Seventy-four limbs (73 patients) were treated with DES and 66 limbs (64 patients) with PTA ± BMS. The costs were calculated by using the mean costs per stent multiplied by the mean number of stents used per patient (€750 × 1.8 for DES vs €250 × 0.3 for PTA ± BMS). These costs were compared with the costs of major amputation (€16.000) and rehabilitation (first year €15.750, second year €7.375 and third year €3.600). Results: The 5-year major amputation rate was lower in the DES group (19.3% vs 34.0% for PTA ± BMS; p = 0.091). In addition, the 5-year amputation-free survival and event-free survival were significantly higher in the DES group (31.8% vs 20.4%, p=0.043; and 26.2% vs 15.3%, p=0.041, respectively). After 1 year, the cost difference per patient between DES and PTA ± BMS is €1.679 in favor of DES and €2.694 after 3 years. Conclusion: In our analysis, DES are cost-effective due to the higher hospital costs of amputation and rehabilitation in the PTA ± BMS group. Level of Evidence: Level 1b, analysis based on clinically sensible costs and randomized controlled trial.