Thijs Wakkie1, Louise C D Konijn2, Nils P C van Herpen3, Martijn F H Maessen3, Marlon I Spreen2, Jan J Wever4, Randolph G Statius van Eps4, Hugo T Veger4, Lukas C van Dijk2, Willem P Th M Mali5, Hans van Overhagen6. 1. Department of Interventional Radiology, Haga Teaching Hospital, Postbus 40551, 2504 LN, The Hague, The Netherlands. twakkie@gmail.com. 2. Department of Interventional Radiology, Haga Teaching Hospital, Postbus 40551, 2504 LN, The Hague, The Netherlands. 3. VGZ Health Insurance, Nijmegen, The Netherlands. 4. Department of Vascular Surgery, Haga Teaching Hospital, The Hague, The Netherlands. 5. Department of Radiology, University Medical Centre Utrecht, Utrecht, The Netherlands. 6. Department of Interventional Radiology, Haga Teaching Hospital, Postbus 40551, 2504 LN, The Hague, The Netherlands. h.voverhagen@hagaziekenhuis.nl.
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.
RCT Entities:
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.
Authors: Louise C D Konijn; Thijs Wakkie; Marlon I Spreen; Pim A de Jong; Lukas C van Dijk; Jan J Wever; Hugo T C Veger; Randolph G Statius van Eps; Willem P Th M Mali; Hendrik van Overhagen Journal: Cardiovasc Intervent Radiol Date: 2020-07-28 Impact factor: 2.740