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CardioVascular and Interventional Radiology

Erschienen in:

05.12.2019 | Clinical Investigation

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

verfasst von: Thijs Wakkie, Louise C. D. Konijn, Nils P. C. van Herpen, Martijn F. H. Maessen, Marlon I. Spreen, Jan J. Wever, Randolph G. Statius van Eps, Hugo T. Veger, Lukas C. van Dijk, Willem P.Th.M. Mali, Hans van Overhagen

Erschienen in: CardioVascular and Interventional Radiology | Ausgabe 3/2020

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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.

Norgren L, Hiatt WR, Dormandy JA, Nehler MR, Harris KA, Fowkes FG, et al. Inter-society consensus for the management of peripheral arterial disease (TASC II). J Vasc Surg. 2007;45(Suppl S):S5–67. https://doi.org/10.1016/j.jvs.2006.12.037.CrossRefPubMed

Spreen MI, Gremmels H, Teraa M, Sprengers RW, Verhaar MC, van Eps RGS, et al. Diabetes is associated with decreased limb survival in patients with critical limb ischemia: pooled data from two randomized controlled trials. Diabetes Care. 2016;39(11):2058–64. https://doi.org/10.2337/dc16-0850.CrossRefPubMed

Graziani L, Silvestro A, Bertone V, Manara E, Andreini R, Sigala A, et al. Vascular involvement in diabetic subjects with ischemic foot ulcer: a new morphologic categorization of disease severity. Eur J Vasc Endovasc Surg: Off J Eur Soc Vasc Surg. 2007;33(4):453–60. https://doi.org/10.1016/j.ejvs.2006.11.022.CrossRef

Teraa M, Conte MS, Moll FL, Verhaar MC. Critical limb ischemia: current trends and future directions. J Am Heart Assoc. 2016;5(2):e002938. https://doi.org/10.1161/jaha.115.002938.CrossRefPubMedPubMedCentral

Rooke TW, Hirsch AT, Misra S, Sidawy AN, Beckman JA, Findeiss L, et al. Management of patients with peripheral artery disease (compilation of 2005 and 2011 ACCF/AHA guideline recommendations): a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol. 2013;61(14):1555–70. https://doi.org/10.1016/j.jacc.2013.01.004.CrossRefPubMed

Adam DJ, Beard JD, Cleveland T, Bell J, Bradbury AW, Forbes JF, et al. Bypass versus angioplasty in severe ischaemia of the leg (BASIL): multicentre, randomised controlled trial. Lancet. 2005;366(9501):1925–34. https://doi.org/10.1016/S0140-6736(05)67704-5.CrossRefPubMed

Hicks CW, Najafian A, Farber A, Menard MT, Malas MB, Black JH, et al. Below-knee endovascular interventions have better outcomes compared to open bypass for patients with critical limb ischemia. Vasc Med. 2017;22(1):28–34. https://doi.org/10.1177/1358863X16676901.CrossRefPubMed

Nehler MR, Coll JR, Hiatt WR, Regensteiner JG, Schnickel GT, Klenke WA, et al. Functional outcome in a contemporary series of major lower extremity amputations. J Vasc Surg. 2003;38(1):7–14.CrossRef

Mustapha JA, Finton SM, Diaz-Sandoval LJ, Saab FA, Miller LE. Percutaneous transluminal angioplasty in patients with infrapopliteal arterial disease: systematic review and meta-analysis. Circ Cardiovasc Interv. 2016;9(5):e003468. https://doi.org/10.1161/CIRCINTERVENTIONS.115.003468.CrossRefPubMed

10.

Bosiers M, Scheinert D, Peeters P, Torsello G, Zeller T, Deloose K, et al. Randomized comparison of everolimus-eluting versus bare-metal stents in patients with critical limb ischemia and infrapopliteal arterial occlusive disease. J Vasc Surg. 2012;55(2):390–8. https://doi.org/10.1016/j.jvs.2011.07.099.CrossRefPubMed

11.

Falkowski A, Poncyljusz W, Wilk G, Szczerbo-Trojanowska M. The evaluation of primary stenting of sirolimus-eluting versus bare-metal stents in the treatment of atherosclerotic lesions of crural arteries. Eur Radiol. 2009;19(4):966–74. https://doi.org/10.1007/s00330-008-1225-1.CrossRefPubMed

12.

Siablis D, Kitrou PM, Spiliopoulos S, Katsanos K, Karnabatidis D. Paclitaxel-coated balloon angioplasty versus drug-eluting stenting for the treatment of infrapopliteal long-segment arterial occlusive disease: the IDEAS randomized controlled trial. JACC Cardiovasc Interv. 2014;7(9):1048–56. https://doi.org/10.1016/j.jcin.2014.04.015.CrossRefPubMed

13.

Rastan A, Brechtel K, Krankenberg H, Zahorsky R, Tepe G, Noory E, et al. Sirolimus-eluting stents for treatment of infrapopliteal arteries reduce clinical event rate compared to bare-metal stents: long-term results from a randomized trial. J Am Coll Cardiol. 2012;60(7):587–91. https://doi.org/10.1016/j.jacc.2012.04.035.CrossRefPubMed

14.

Scheinert D, Katsanos K, Zeller T, Koppensteiner R, Commeau P, Bosiers M, et al. A prospective randomized multicenter comparison of balloon angioplasty and infrapopliteal stenting with the sirolimus-eluting stent in patients with ischemic peripheral arterial disease: 1-year results from the ACHILLES trial. J Am Coll Cardiol. 2012;60(22):2290–5. https://doi.org/10.1016/j.jacc.2012.08.989.CrossRefPubMed

15.

Rastan A, Tepe G, Krankenberg H, Zahorsky R, Beschorner U, Noory E, et al. Sirolimus-eluting stents versus bare-metal stents for treatment of focal lesions in infrapopliteal arteries: a double-blind, multi-centre, randomized clinical trial. Eur Heart J. 2011;32(18):2274–81. https://doi.org/10.1093/eurheartj/ehr144.CrossRefPubMed

16.

Spreen MI, Martens JM, Hansen BE, Knippenberg B, Verhey E, van Dijk LC, et al. Percutaneous transluminal angioplasty and drug-eluting stents for infrapopliteal lesions in critical limb ischemia (PADI) trial. Circ Cardiovasc Interv. 2016;9(2):e002376. https://doi.org/10.1161/CIRCINTERVENTIONS.114.002376.CrossRefPubMedPubMedCentral

17.

Spreen MI, Martens JM, Knippenberg B, van Dijk LC, de Vries JPM, Vos JA, et al. Long-term follow-up of the PADI trial: percutaneous transluminal angioplasty versus drug-eluting stents for infrapopliteal lesions in critical limb ischemia. J Am Heart Assoc. 2017;6(4):e004877. https://doi.org/10.1161/jaha.116.004877.CrossRefPubMedPubMedCentral

18.

Rutherford RB, Baker JD, Ernst C, Johnston KW, Porter JM, Ahn S, et al. Recommended standards for reports dealing with lower extremity ischemia: revised version. J Vasc Surg. 1997;26(3):517–38.CrossRef

19.

Katsanos K, Karnabatidis D, Diamantopoulos A, Spiliopoulos S, Siablis D. Cost-effectiveness analysis of infrapopliteal drug-eluting stents. Cardiovasc Interv Radiol. 2013;36(1):90–7. https://doi.org/10.1007/s00270-012-0370-8.CrossRef

20.

Sridharan ND, Boitet A, Smith K, Noorbakhsh K, Avgerinos E, Eslami MH, et al. Cost-effectiveness analysis of drug-coated therapies in the superficial femoral artery. J Vasc Surg. 2018;67(1):343–52. https://doi.org/10.1016/j.jvs.2017.06.112.CrossRefPubMed

21.

Locham SS, Paracha N, Dakour-Aridi H, Nejim B, Rizwan M, Malas MB. comparison of the cost of drug-eluting stents versus bare metal stents in the treatment of critical limb ischemia in the United States. Ann Vasc Surg. 2019;55(55–62):e2. https://doi.org/10.1016/j.avsg.2018.05.051.CrossRef

22.

Secemsky EA, Kundi H, Weinberg I, Jaff MR, Krawisz A, Parikh SA, et al. Association of survival with femoropopliteal artery revascularization with drug-coated devices. JAMA Cardiol. 2019. https://doi.org/10.1001/jamacardio.2019.0325.CrossRefPubMedPubMedCentral

23.

Secemsky EA, Kundi H, Weinberg I, Schermerhorn M, Beckman JA, Parikh SA, et al. Drug-eluting stent implantation and long-term survival following peripheral artery revascularization. J Am Coll Cardiol. 2019;73(20):2636–8. https://doi.org/10.1016/j.jacc.2019.02.020.CrossRefPubMed

24.

Katsanos K, Spiliopoulos S, Kitrou P, Krokidis M, Karnabatidis D. Risk of death following application of paclitaxel-coated balloons and stents in the femoropopliteal artery of the leg: a systematic review and meta-analysis of randomized controlled trials. J Am Heart Assoc. 2018;7(24):e011245. https://doi.org/10.1161/JAHA.118.011245.CrossRefPubMedPubMedCentral

25.

Becker F, Robert-Ebadi H, Ricco JB, Setacci C, Cao P, de Donato G, et al. Chapter I: definitions, epidemiology, clinical presentation and prognosis. Eur J Vasc Endovasc Surg: Off J Eur Soc Vasc Surg. 2011;42(Suppl 2):S4–12. https://doi.org/10.1016/S1078-5884(11)60009-9.CrossRef

26.

Varu VN, Hogg ME, Kibbe MR. Critical limb ischemia. J Vasc Surg. 2010;51(1):230–41. https://doi.org/10.1016/j.jvs.2009.08.073.CrossRefPubMed

27.

Dormandy J, Heeck L, Vig S. The fate of patients with critical leg ischemia. Semin Vasc Surg. 1999;12(2):142–7.PubMed

28.

Feiring AJ. Footnotes on critical limb ischemia. J Am Coll Cardiol. 2008;51(20):1975–6. https://doi.org/10.1016/j.jacc.2008.02.041.CrossRefPubMed

Titel: Cost-Effectiveness of Drug-Eluting Stents for Infrapopliteal Lesions in Patients with Critical Limb Ischemia: The PADI Trial
verfasst von: Thijs Wakkie
Louise C. D. Konijn
Nils P. C. van Herpen
Martijn F. H. Maessen
Marlon I. Spreen
Jan J. Wever
Randolph G. Statius van Eps
Hugo T. Veger
Lukas C. van Dijk
Willem P.Th.M. Mali
Hans van Overhagen
Publikationsdatum: 05.12.2019
Verlag: Springer US
Erschienen in: CardioVascular and Interventional Radiology / Ausgabe 3/2020
Print ISSN: 0174-1551
Elektronische ISSN: 1432-086X
DOI: https://doi.org/10.1007/s00270-019-02385-5

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