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

  • Clinical Investigation
  • Arterial Interventions
  • Published:
CardioVascular and Interventional Radiology Aims and scope Submit manuscript

Abstract

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.

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Funding

This study was not supported by any funding.

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Authors and Affiliations

  1. Department of Interventional Radiology, Haga Teaching Hospital, Postbus 40551, 2504 LN, The Hague, The Netherlands

    Thijs Wakkie, Louise C. D. Konijn, Marlon I. Spreen, Lukas C. van Dijk & Hans van Overhagen

  2. VGZ Health Insurance, Nijmegen, The Netherlands

    Nils P. C. van Herpen & Martijn F. H. Maessen

  3. Department of Vascular Surgery, Haga Teaching Hospital, The Hague, The Netherlands

    Jan J. Wever, Randolph G. Statius van Eps & Hugo T. Veger

  4. Department of Radiology, University Medical Centre Utrecht, Utrecht, The Netherlands

    Willem P.Th.M. Mali

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  1. Thijs Wakkie
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Correspondence to Thijs Wakkie or Hans van Overhagen.

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Conflict of interest

Hans van Overhagen is PI of the PADI trial, PI of the SAVAL trail and consultant of Boston Scientific. The remaining authors declare that they have no conflict of interest.

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Wakkie, T., Konijn, L.C.D., van Herpen, N.P.C. et al. Cost-Effectiveness of Drug-Eluting Stents for Infrapopliteal Lesions in Patients with Critical Limb Ischemia: The PADI Trial. Cardiovasc Intervent Radiol 43, 376–381 (2020). https://doi.org/10.1007/s00270-019-02385-5

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