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.
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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
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
Lemos PA, Serruys PW, Sousa JE (2003) Drug-eluting stents: cost versus clinical benefit. Circulation 107(24):3003–3007
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
Karnabatidis D, Katsanos K, Siablis D (2009) Infrapopliteal stents: overview and unresolved issues. J Endovasc Ther 16(Suppl 1):I153–I162
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
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
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
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
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
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
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
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
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
Popma JJ, Topol EJ (1990) Factors influencing restenosis after coronary angioplasty. Am J Med 88(1N):16N–24N
Karas SP, Santoian EC, Gravanis MB (1991) Restenosis following coronary angioplasty. Clin Cardiol 14(10):791–801
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
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
Diamond GA, Kaul S (2009) Cost, effectiveness, and cost-effectiveness. Circ Cardiovasc Qual Outcomes 2(1):49–54
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
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
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
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
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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
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DOI: https://doi.org/10.1007/s00270-012-0370-8