Skip to main content
Log in

Cost-Effectiveness Analysis of Infrapopliteal Drug-Eluting Stents

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

Abstract

Introduction

There are no cost-utility data about below-the-knee placement of drug-eluting stents. The authors determined the cost-effectiveness of infrapopliteal drug-eluting stents for critical limb ischemia (CLI) treatment.

Methods

The event-free individual survival outcomes defined by the absence of any major events, including death, major amputation, and target limb repeat procedures, were reconstructed on the basis of two published infrapopliteal series. The first included spot Bail-out use of Sirolimus-eluting stents versus bare metal stents after suboptimal balloon angioplasty (Bail-out SES).The second was full-lesion Primary Everolimus-eluting stenting versus plain balloon angioplasty and bail-out bare metal stenting as necessary (primary EES). The number-needed-to-treat (NNT) to avoid one major event and incremental cost-effectiveness ratios (ICERs) were calculated for a 3-year postprocedural period for both strategies.

Results

Overall event-free survival was significantly improved in both strategies (hazard ratio (HR) [confidence interval (CI)]: 0.68 [0.41–1.12] in Bail-out SES and HR [CI]: 0.53 [0.29–0.99] in Primary EES). Event-free survival gain per patient was 0.89 (range, 0.11–3.0) years in Bail-out SES with an NNT of 4.6 (CI: 2.5–25.6) and a corresponding ICER of 6,518€ (range 1,685–10,112€). Survival gain was 0.91 (range 0.25–3.0) years in Primary EES with an NNT of 2.7 (CI: 1.7–5.8) and an ICER of 11,581€ (range, 4,945–21,428€) per event-free life-year gained. Two-way sensitivity analysis showed that stented lesion length >10 cm and/or DES list price >1000€ were associated with the least economically favorable scenario in both strategies.

Conclusions

Both strategies of bail-out SES and primary EES placement in the infrapopliteal arteries for CLI treatment exhibit single-digit NNT and relatively low corresponding ICERs.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Fig. 1
Fig. 2
Fig. 3
Fig. 4

Similar content being viewed by others

Abbreviations

CLI:

Critical limb ischemia

DES:

Drug-eluting stents

SES:

Sirolimus-eluting stents

EES:

Everolimus-eluting stents

NNT:

Number needed to treat

ICER:

Incremental cost-effectiveness ratio

HR:

Hazard ratio

AUC:

Area under the curve

ARR:

Absolute risk reduction

References

  1. Conrad MF, Crawford RS, Hackney LA et al (2011) Endovascular management of patients with critical limb ischemia: long-term results. J Vasc Surg 53(4):1020–1025

    Article  PubMed  Google Scholar 

  2. Lemos PA, Serruys PW, Sousa JE (2003) Drug-eluting stents: cost versus clinical benefit. Circulation 107(24):3003–3007

    Article  PubMed  Google Scholar 

  3. Siablis D, Katsanos K, Karnabatidis D (2010) Commentary: infrapopliteal angioplasty with drug-eluting stents: from heart to toe. J Endovasc Ther 17(4):488–491

    Article  PubMed  Google Scholar 

  4. Karnabatidis D, Katsanos K, Siablis D (2009) Infrapopliteal stents: overview and unresolved issues. J Endovasc Ther 16(Suppl 1):I153–I162

    PubMed  Google Scholar 

  5. Siablis D, Karnabatidis D, Katsanos K, Diamantopoulos A, Christeas N, Kagadis GC (2007) Infrapopliteal application of paclitaxel-eluting stents for critical limb ischemia: midterm angiographic and clinical results. J Vasc Interv Radiol 18(11):1351–1361

    Article  PubMed  Google Scholar 

  6. Falkowski A, Poncyljusz W, Wilk G, Szczerbo-Trojanowska M (2009) The evaluation of primary stenting of sirolimus-eluting versus bare-metal stents in the treatment of atherosclerotic lesions of crural arteries. Eur Radiol 19(4):966–974

    Article  PubMed  Google Scholar 

  7. Feiring AJ, Krahn M, Nelson L, Wesolowski A, Eastwood D, Szabo A (2011) Preventing leg amputations in critical limb ischemia with below-the-knee drug-eluting stents: the PaRADISE (PReventing Amputations using Drug eluting StEnts) trial. J Am Coll Cardiol 55(15):1580–1589

    Article  Google Scholar 

  8. Siablis D, Karnabatidis D, Katsanos K et al (2007) Sirolimus-eluting versus bare stents after suboptimal infrapopliteal angioplasty for critical limb ischemia: enduring 1-year angiographic and clinical benefit. J Endovasc Ther 14(2):241–250

    Article  PubMed  Google Scholar 

  9. Siablis D, Kraniotis P, Karnabatidis D, Kagadis GC, Katsanos K, Tsolakis J (2005) Sirolimus-eluting versus bare stents for bailout after suboptimal infrapopliteal angioplasty for critical limb ischemia: 6-month angiographic results from a nonrandomized prospective single-center study. J Endovasc Ther 12(6):685–695

    Article  PubMed  Google Scholar 

  10. Karnabatidis D, Spiliopoulos S, Diamantopoulos A et al (2011) Primary everolimus-eluting stenting versus balloon angioplasty with bailout bare metal stenting of long infrapopliteal lesions for treatment of critical limb ischemia. J Endovasc Ther 18(1):1–12

    Article  PubMed  Google Scholar 

  11. Siablis D, Karnabatidis D, Katsanos K et al (2009) Infrapopliteal application of sirolimus-eluting versus bare metal stents for critical limb ischemia: analysis of long-term angiographic and clinical outcome. J Vasc Interv Radiol 20(9):1141–1150

    Article  PubMed  Google Scholar 

  12. Biondi-Zoccai G, Lotrionte M, Moretti C et al (2008) Percutaneous coronary intervention with everolimus-eluting stents (Xience V): systematic review and direct-indirect comparison meta-analyses with paclitaxel-eluting stents (Taxus) and sirolimus-eluting stents (Cypher). Minerva Cardioangiol 56(1):55–65

    PubMed  CAS  Google Scholar 

  13. Cassese S, Piccolo R, Galasso G, De Rosa R, Piscione F (2011) Twelve-month clinical outcomes of everolimus-eluting stent as compared to paclitaxel- and sirolimus-eluting stent in patients undergoing percutaneous coronary interventions. A meta-analysis of randomized clinical trials. Int J Cardiol 150(1):84–89

    Article  PubMed  Google Scholar 

  14. Popma JJ, Topol EJ (1990) Factors influencing restenosis after coronary angioplasty. Am J Med 88(1N):16N–24N

    PubMed  CAS  Google Scholar 

  15. Karas SP, Santoian EC, Gravanis MB (1991) Restenosis following coronary angioplasty. Clin Cardiol 14(10):791–801

    Article  PubMed  CAS  Google Scholar 

  16. Rastan A, Schwarzwalder U, Noory E et al (2010) Primary use of sirolimus-eluting stents in the infrapopliteal arteries. J Endovasc Ther 17(4):480–487

    Article  PubMed  Google Scholar 

  17. Scheinert D, Ulrich M, Scheinert S, Sax J, Braunlich S, Biamino G (2006) Comparison of sirolimus-eluting vs. bare-metal stents for the treatment of infrapopliteal obstructions. EuroIntervention 2(2):169–174

    PubMed  Google Scholar 

  18. Diamond GA, Kaul S (2009) Cost, effectiveness, and cost-effectiveness. Circ Cardiovasc Qual Outcomes 2(1):49–54

    Article  PubMed  Google Scholar 

  19. Remak E, Manson S, Hutton J, Brasseur P, Olivier E, Gershlick A (2010) Cost-effectiveness of the Endeavor stent in de novo native coronary artery lesions updated with contemporary data. EuroIntervention 5(7):826–832

    Article  PubMed  Google Scholar 

  20. Redekop WK, Stolk EA, Kok E, Lovas K, Kalo Z, Busschbach JJ (2004) Diabetic foot ulcers and amputations: estimates of health utility for use in cost-effectiveness analyses of new treatments. Diabetes Metab 30(6):549–556

    Article  PubMed  CAS  Google Scholar 

  21. Ortegon MM, Redekop WK, Niessen LW (2004) Cost-effectiveness of prevention and treatment of the diabetic foot: a Markov analysis. Diabetes Care 27(4):901–907

    Article  PubMed  Google Scholar 

  22. Ragnarson Tennvall G, Apelqvist J (2001) Prevention of diabetes-related foot ulcers and amputations: a cost-utility analysis based on Markov model simulations. Diabetologia 44(11):2077–2087

    Article  PubMed  CAS  Google Scholar 

Download references

Conflicts of interest

All authors state that they have no conflicts of interest to declare.

Author information

Authors and Affiliations

Authors

Corresponding author

Correspondence to Konstantinos Katsanos.

Rights and permissions

Reprints and permissions

About this article

Cite this article

Katsanos, K., Karnabatidis, D., Diamantopoulos, A. et al. Cost-Effectiveness Analysis of Infrapopliteal Drug-Eluting Stents. Cardiovasc Intervent Radiol 36, 90–97 (2013). https://doi.org/10.1007/s00270-012-0370-8

Download citation

  • Received:

  • Accepted:

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s00270-012-0370-8

Keywords

Navigation