Cost-effectiveness of everolimus-eluting versus bare-metal stents in ST-segment elevation myocardial infarction: An analysis from the EXAMINATION randomized controlled trial

Nadine Schur, Salvatore Brugaletta, Angel Cequier, Andrés Iñiguez, Antonio Serra, Pilar Jiménez-Quevedo, Vicente Mainar, Gianluca Campo, Maurizio Tespili, Peter den Heijer, Armando Bethencourt, Nicolás Vazquez, Marco Valgimigli, Patrick W Serruys, Zanfina Ademi, Matthias Schwenkglenks, Manel Sabaté, Nadine Schur, Salvatore Brugaletta, Angel Cequier, Andrés Iñiguez, Antonio Serra, Pilar Jiménez-Quevedo, Vicente Mainar, Gianluca Campo, Maurizio Tespili, Peter den Heijer, Armando Bethencourt, Nicolás Vazquez, Marco Valgimigli, Patrick W Serruys, Zanfina Ademi, Matthias Schwenkglenks, Manel Sabaté

Abstract

Background: Use of everolimus-eluting stents (EES) has proven to be clinically effective and safe in patients with ST-segment elevation myocardial infarction but it remains unclear whether it is cost-effective compared to bare-metal stents (BMS) in the long-term. We sought to assess the cost-effectiveness of EES versus BMS based on the 5-year results of the EXAMINATION trial, from a Spanish health service perspective.

Methods: Decision analysis of the use of EES versus BMS was based on the patient-level clinical outcome data of the EXAMINATION trial. The analysis adopted a lifelong time horizon, assuming that long-term survival was independent of the initial treatment strategy after the end of follow-up. Life-expectancy, health-state utility scores and unit costs were extracted from published literature and publicly available sources. Non-parametric bootstrapping was combined with probabilistic sensitivity analysis to co-assess the impact of patient-level variation and parameter uncertainty. The main outcomes were total costs and quality-adjusted life-years. The incremental cost-effectiveness ratio was expressed as cost per quality-adjusted life-years gained. Costs and effects were discounted at 3%.

Results: The model predicted an average survival time in patients receiving EES and BMS of 10.52 and 10.38 undiscounted years, respectively. Over the life-long time horizon, the EES strategy was €430 more costly than BMS (€8,305 vs. €7,874), but went along with incremental gains of 0.10 quality-adjusted life-years. This resulted in an average incremental cost-effectiveness ratio over all simulations of €3,948 per quality-adjusted life-years gained and was below a willingness-to-pay threshold of €25,000 per quality-adjusted life-years gained in 86.9% of simulation runs.

Conclusions: Despite higher total costs relative to BMS, EES appeared to be a cost-effective therapy for ST-segment elevation myocardial infarction patients due to their incremental effectiveness. Predicted incremental cost-effectiveness ratios were below generally acceptable threshold values.

Trial registration: ClinicalTrials.gov NCT00828087.

Conflict of interest statement

The authors have declared that no competing interests exist.

Figures

Fig 1. Cost effectiveness plane.
Fig 1. Cost effectiveness plane.
QALY = quality-adjusted life-year.
Fig 2. Cost-effectiveness acceptability curve.
Fig 2. Cost-effectiveness acceptability curve.
BMS = bare-metal stent. EES = everolimus-eluting stent. QALY = quality-adjusted life-year.
Fig 3. Tornado diagram showing the impact…
Fig 3. Tornado diagram showing the impact of uncertainty on the outcome of the modelling parameters.
ICER = incremental cost-effectiveness ratio. MI = myocardial infarction. STT = stent thrombosis.
Fig 4. Graph showing the impact of…
Fig 4. Graph showing the impact of the difference in stent cost on the ICER.
BMS = bare-metal stent. EES = everolimus-eluting stent. ICER = incremental cost-effectiveness ratio. QALY = quality-adjusted life-year.

References

    1. Sanchis-Gomar F, Perez-Quilis C, Leischik R, Lucia A. Epidemiology of coronary heart disease and acute coronary syndrome. Ann Transl Med. 2016;4(13):256 10.21037/atm.2016.06.33 ; PubMed Central PMCID: PMCPMC4958723.
    1. Franken M, Nussbacher A, Liberman A, Wajngarten M. ST Elevation Myocardial Infarction in the elderly. J Geriatr Cardiol. 2012;9(2):108–14. 10.3724/SP.J.1263.2011.12297 ; PubMed Central PMCID: PMCPMC3418898.
    1. Bangalore S, Guo Y, Samadashvili Z, Blecker S, Xu J, Hannan EL. Everolimus-eluting stents or bypass surgery for multivessel coronary disease. N Engl J Med. 2015;372(13):1213–22. 10.1056/NEJMoa1412168 .
    1. Sabate M, Cequier A, Iniguez A, Serra A, Hernandez-Antolin R, Mainar V, et al. Rationale and design of the EXAMINATION trial: a randomised comparison between everolimus-eluting stents and cobalt-chromium bare-metal stents in ST-elevation myocardial infarction. EuroIntervention. 2011;7(8):977–84. 10.4244/EIJV7I8A154 .
    1. Sabate M, Brugaletta S, Cequier A, Iniguez A, Serra A, Jimenez-Quevedo P, et al. Clinical outcomes in patients with ST-segment elevation myocardial infarction treated with everolimus-eluting stents versus bare-metal stents (EXAMINATION): 5-year results of a randomised trial. Lancet. 2016;387(10016):357–66. 10.1016/S0140-6736(15)00548-6 .
    1. Cutlip DE, Windecker S, Mehran R, Boam A, Cohen DJ, van Es GA, et al. Clinical end points in coronary stent trials: a case for standardized definitions. Circulation. 2007;115(17):2344–51. 10.1161/CIRCULATIONAHA.106.685313 .
    1. Vranckx P, Cutlip DE, Mehran R, Kint PP, Silber S, Windecker S, et al. Myocardial infarction adjudication in contemporary all-comer stent trials: balancing sensitivity and specificity. Addendum to the historical MI definitions used in stent studies. EuroIntervention. 2010;5(7):871–4. .
    1. World Life Expectancy. Spain life expectancy by age. (Accessed: 06 Feb 2016).
    1. Bucholz EM, Normand SL, Wang Y, Ma S, Lin H, Krumholz HM. Life Expectancy and Years of Potential Life Lost After Acute Myocardial Infarction by Sex and Race: A Cohort-Based Study of Medicare Beneficiaries. J Am Coll Cardiol. 2015;66(6):645–55. 10.1016/j.jacc.2015.06.022 .
    1. Szende A, Cabasés JM, Janssen B. Self-Reported Population Health: An International Perspective based on EQ-5D [text] Place of publication not identified: Springer; Netherlands; 2014.
    1. Lacey EA, Walters SJ. Continuing inequality: gender and social class influences on self perceived health after a heart attack. J Epidemiol Community Health. 2003;57(8):622–7. 10.1136/jech.57.8.622 ; PubMed Central PMCID: PMCPMC1732552.
    1. Busse R, Geissler A, Aaviksoo A, Cots F, Hakkinen U, Kobel C, et al. Diagnosis related groups in Europe: moving towards transparency, efficiency, and quality in hospitals? BMJ (Clinical research ed). 2013;346:f3197 10.1136/bmj.f3197 .
    1. Vergel YB, Palmer S, Asseburg C, Fenwick E, Abrams KR, de Belder M, et al. The cost-effectiveness of primary angioplasty compared to thrombolytic therapy for acute myocardial infarction in the UK NHS. York: Centre for Health Economics, 2006.
    1. Schwenkglenks M, Toward TJ, Plent S, Szucs TD, Blackman DJ, Baumbach A. Cost-effectiveness of bivalirudin versus heparin plus glycoprotein IIb/IIIa inhibitor in the treatment of acute ST-segment elevation myocardial infarction. Heart. 2012;98(7):544–51. 10.1136/heartjnl-2011-301323 .
    1. Lopez Bastida J, Oliva J, Antonanzas F, Garcia-Altes A, Gisbert R, Mar J, et al. [A proposed guideline for economic evaluation of health technologies]. Gac Sanit. 2010;24(2):154–70. Epub 2009/12/05. 10.1016/j.gaceta.2009.07.011 .
    1. The World Bank. Gross domestic product per capita for Spain. (Accessed: 01 Aug 2017) [2017 Aug 01]. Available from: .
    1. Hutubessy R, Chisholm D, Edejer TT. Generalized cost-effectiveness analysis for national-level priority-setting in the health sector. Cost Eff Resour Alloc. 2003;1(1):8 10.1186/1478-7547-1-8 ; PubMed Central PMCID: PMCPMC320499.
    1. Lord J, Asante MA. Estimating uncertainty ranges for costs by the bootstrap procedure combined with probabilistic sensitivity analysis. Health Econ. 1999;8(4):323–33. .
    1. Ferko N, Ferrante G, Hasegawa JT, Schikorr T, Soleas IM, Hernandez JB, et al. Cost-effectiveness of percutaneous coronary intervention with cobalt-chromium everolimus eluting stents versus bare metal stents: Results from a patient level meta-analysis of randomized trials. Catheter Cardiovasc Interv. 2017;89(6):994–1002. 10.1002/ccd.26700 ; PubMed Central PMCID: PMCPMC5434913.
    1. Applegate R, Sacrinty M, Schafer P, Smith J, Gandhi S, Kutcher M, et al. Cost effectiveness of radial access for diagnostic cardiac catheterization and coronary intervention. Catheter Cardiovasc Interv. 2013;82(4):E375–84. 10.1002/ccd.24696 .
    1. Poder TG, Erraji J, Coulibaly LP, Koffi K. Percutaneous coronary intervention with second-generation drug-eluting stent versus bare-metal stent: Systematic review and cost-benefit analysis. PloS one. 2017;12(5). doi: ARTN e0177476 10.1371/journal.pone.0177476 PubMed PMID: WOS:000401314500019.
    1. Villemoes MK, Lindholt JS, Houlind KC, Gottschalksen B, Petersen CN, Rasmussen M, et al. Cost-Effectiveness Evaluation of Heparin Coated Versus Standard Graft for Bypass Surgery in Peripheral Artery Disease Alongside a Randomised Controlled Trial. Eur J Vasc Endovasc Surg. 2018;56(1):87–93. Epub 2018/04/07. 10.1016/j.ejvs.2018.03.012 .
    1. Swamy G, Lopatina E, Thomas KC, Marshall DA, Johal HS. The Cost Effectiveness of Minimally Invasive Spine Surgery in the Treatment of Adult Degenerative Scoliosis: A Comparison of Trans-psoas and Open Techniques. Spine J. 2018. Epub 2018/06/03. 10.1016/j.spinee.2018.05.040 .
    1. McCarron CE, Pullenayegum EM, Thabane L, Goeree R, Tarride JE. The impact of using informative priors in a Bayesian cost-effectiveness analysis: an application of endovascular versus open surgical repair for abdominal aortic aneurysms in high-risk patients. Med Decis Making. 2013;33(3):437–50. Epub 2012/10/12. 10.1177/0272989X12458457 .
    1. McCabe C, Claxton K, Culyer AJ. The NICE cost-effectiveness threshold: what it is and what that means. PharmacoEconomics. 2008;26(9):733–44. .

Source: PubMed

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

3
Abonner