Skip to main content

Advertisement

Log in

Cost-effectiveness of paclitaxel-coated balloon angioplasty and paclitaxel-eluting stent implantation for treatment of coronary in-stent restenosis in patients with stable coronary artery disease

  • Original Paper
  • Published:
Clinical Research in Cardiology Aims and scope Submit manuscript

Abstract

Background

Recent studies have demonstrated the safety and efficacy of drug-coated balloon (DCB) angioplasty for the treatment of coronary in-stent restenosis (ISR). The cost-effectiveness of this practice is unknown.

Methods

A Markov state-transition decision analytic model accounting for varying procedural efficacy rates, complication rates, and cost estimates was developed to compare DCB angioplasty with drug-eluting stent (DES) placement in patients with bare-metal stent (BMS)-ISR. Data on procedural outcomes associated with both treatment strategies were derived from the literature, and the cost analysis was conducted from a health care payer perspective. Effectiveness was expressed as life-years gained.

Results

In the base-case analysis, initial procedure costs amounted to €3,604.14 for DCB angioplasty and to €3,309.66 for DES implantation. Over a 12-month time horizon, the DCB strategy was found to be less costly (€4,130.38 vs. €5,305.30) and slightly more effective in terms of life expectancy (0.983 vs. 0.976 years) than the DES strategy. Extensive sensitivity analyses indicated that, in comparison with DES implantation, the cost advantage of the DCB strategy was robust to clinically plausible variations in the values of key model input parameters. The variables with the greatest impact on base-case results were the duration of dual antiplatelet therapy with acetylsalicylic acid and clopidogrel after DCB angioplasty, the use of generic clopidogrel, and variations in the costs associated with the DCB device.

Conclusion

DCB angioplasty is a cost-effective treatment option for coronary BMS-ISR. The higher initial costs of DCB are more than offset by later cost-savings, predominantly as a result of reduced medication costs.

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

Similar content being viewed by others

References

  1. Stone GW, Ellis SG, Cannon L, Mann JT, Greenberg JD, Spriggs D, O’Shaughnessy CD, DeMaio S, Hall P, Popma JJ, Koglin J, Russell ME, TAXUS V Investigators (2005) Comparison of a polymer-based paclitaxel-eluting stent with a bare metal stent in patients with complex coronary artery disease: a randomized controlled trial. JAMA 294:1215–1223

    Article  PubMed  CAS  Google Scholar 

  2. Tentzeris I, Jarai R, Farhan S, Wojta J, Schillinger M, Geppert A, Nürnberg M, Unger G, Huber K (2011) Long-term outcome after drug-eluting stent implantation in comparison with bare metal stents: a single centre experience. Clin Res Cardiol 100:191–200

    Article  PubMed  CAS  Google Scholar 

  3. de Waha A, Dibra A, Kufner S, Baumgart D, Sabate M, Maresta A, Schömig A, Kastrati A (2011) Long-term outcome after sirolimus-eluting stents versus bare metal stents in patients with diabetes mellitus: a patient-level meta-analysis of randomized trials. Clin Res Cardiol 100:561–570

    Article  PubMed  CAS  Google Scholar 

  4. Clark MA, Bakhai A, Pelletier EM, Cohen DJ (2005) Clinical and economic effects of coronary restenosis after percutaneous coronary intervention in a managed care population. Manag Care 14:42–44, 46–51

    Google Scholar 

  5. Wijns W, Kolh P, Danchin N, Di Mario C, Falk V, Folliguet T, Garg S, Huber K, James S, Knuuti J, Lopez-Sendon J, Marco J, Menicanti L, Ostojic M, Piepoli MF, Pirlet C, Pomar JL, Reifart N, Ribichini FL, Schalij MJ, Sergeant P, Serruys PW, Silber S, Sousa Uva M, Taggart D (2010) Guidelines on myocardial revascularization: The Task Force on Myocardial Revascularization of the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS). Eur Heart J 31:2501–2555

    Article  PubMed  Google Scholar 

  6. Holmes DR Jr, Teirstein P, Satler L, Sketch M, O’Malley J, Popma JJ, Kuntz RE, Fitzgerald PJ, Wang H, Caramanica E, Cohen SA, SISR Investigators (2006) Sirolimus-eluting stents vs. vascular brachytherapy for in-stent restenosis within bare-metal stents: the SISR randomized trial. JAMA 295:1264–1273

    Article  PubMed  CAS  Google Scholar 

  7. Kastrati A, Mehilli J, von Beckerath N, Dibra A, Hausleiter J, Pache J, Schuhlen H, Schmitt C, Dirschinger J, Schomig A, ISAR-DESIRE Study Investigators (2005) Sirolimus-eluting stent or paclitaxel-eluting stent vs balloon angioplasty for prevention of recurrences in patients with coronary in-stent restenosis: a randomized controlled trial. JAMA 293:165–171

    Article  PubMed  CAS  Google Scholar 

  8. Pfisterer M, Brunner-La Rocca HP, Buser PT, Rickenbacher P, Hunziker P, Mueller C, Jeger R, Bader F, Osswald S, Kaiser C, BASKET-LATE Investigators (2006) Late clinical events after clopidogrel discontinuation may limit the benefit of drug-eluting stents: an observational study of drug-eluting versus bare-metal stents. J Am Coll Cardiol 48:2584–2591

    Article  PubMed  CAS  Google Scholar 

  9. Daemen J, Wenaweser P, Tsuchida K, Abrecht L, Vaina S, Morger C, Kukreja N, Jüni P, Sianos G, Hellige G, van Domburg RT, Hess OM, Boersma E, Meier B, Windecker S, Serruys PW (2007) Early and late coronary stent thrombosis of sirolimus-eluting and paclitaxel-eluting stents in routine clinical practice: data from a large two-institutional cohort study. Lancet 369:667–678

    Article  PubMed  CAS  Google Scholar 

  10. Waksman R, Pakala R (2009) Drug-eluting balloon: the comeback kid? Circ Cardiovasc Interv 2:352–358

    Article  PubMed  CAS  Google Scholar 

  11. Unverdorben M, Kleber FX, Heuer H, Figulla HR, Vallbracht C, Leschke M, Cremers B, Hardt S, Buerke M, Ackermann H, Boxberger M, Degenhardt R, Scheller B (2010) Treatment of small coronary arteries with a paclitaxel-coated balloon catheter. Clin Res Cardiol 99:165–174

    Article  PubMed  CAS  Google Scholar 

  12. Scheller B, Hehrlein C, Bocksch W, Rutsch W, Haghi D, Dietz U, Böhm M, Speck U (2006) Treatment of coronary in-stent restenosis with a paclitaxel-coated balloon catheter. N Engl J Med 355:2113–2124

    Article  PubMed  CAS  Google Scholar 

  13. Scheller B, Hehrlein C, Bocksch W, Rutsch W, Haghi D, Dietz U, Böhm M, Speck U (2008) Two year follow-up after treatment of coronary in-stent restenosis with a paclitaxel-coated balloon catheter. Clin Res Cardiol 97:773–781

    Article  PubMed  Google Scholar 

  14. Unverdorben M, Vallbracht C, Cremers B, Heuer H, Hengstenberg C, Maikowski C, Werner GS, Antoni D, Kleber FX, Bocksch W, Leschke M, Ackermann H, Boxberger M, Speck U, Degenhardt R, Scheller B (2009) Paclitaxel-coated balloon catheter versus paclitaxel-coated stent for the treatment of coronary in-stent restenosis. Circulation 119:2986–2994

    Article  PubMed  CAS  Google Scholar 

  15. Cremers B, Clever Y, Schaffner S, Speck U, Böhm M, Scheller B (2010) Treatment of coronary in-stent restenosis with a novel paclitaxel urea coated balloon. Minerva Cardioangiol 58:583–588

    PubMed  CAS  Google Scholar 

  16. Stella PR, Belkacemi A, Waksman R, Stahnke S, Torguson R, von Strandmann RP, Agostoni P, Sangiorgi G, Silber S, Valentine Investigators (2011) The Valentines Trial: results of the first one week worldwide multicentre enrolment trial, evaluating the real world usage of the second generation DIOR paclitaxel drug-eluting balloon for in-stent restenosis treatment. EuroIntervention 7:705–710

    Article  PubMed  Google Scholar 

  17. Peden S, Latimer L (2011) National Institute for Health and Clinical Excellence. Assessment report summary—SeQuent Please balloon catheter. http://www.nice.org.uk/nicemedia/live/13002/49625/49625.pdf. Accessed September 4, 2011

  18. Petrou S, Gray A (2011) Economic evaluation using decision analytical modelling: design, conduct, analysis, and reporting. BMJ 342:d1766

    Article  PubMed  Google Scholar 

  19. Stone GW, Mehran R, Dangas G, Lansky AJ, Kornowski R, Leon MB (2001) Differential impact on survival of electrocardiographic Q-wave versus enzymatic myocardial infarction after percutaneous intervention: a device-specific analysis of 7147 patients. Circulation 104:642–647

    Article  PubMed  CAS  Google Scholar 

  20. Aldea GS, Mokadam NA, Melford R Jr, Stewart D, Maynard C, Reisman M, Goss R (2009) Changing volumes, risk profiles, and outcomes of coronary artery bypass grafting and percutaneous coronary interventions. Ann Thorac Surg 87:1828–1838

    Article  PubMed  Google Scholar 

  21. Hoffman SJ, Holmes DR Jr, Rabinstein AA, Rihal CS, Gersh BJ, Lennon RJ, Bashir R, Gulati R (2011) Trends, predictors, and outcomes of cerebrovascular events related to percutaneous coronary intervention: a 16-year single-center experience. JACC Cardiovasc Interv 4:415–422

    Article  PubMed  Google Scholar 

  22. Hannan EL, Racz M, Walford G (2011) Out-of-hospital deaths within 30 days following hospitalization where percutaneous coronary intervention was performed. Am J Cardiol (in press)

  23. Kastrati A, Dibra A, Eberle S, Mehilli J, Suárez de Lezo J, Goy JJ, Ulm K, Schömig A (2005) Sirolimus-eluting stents vs. paclitaxel-eluting stents in patients with coronary artery disease: meta-analysis of randomized trials. JAMA 294:819–825

    Article  PubMed  CAS  Google Scholar 

  24. Tarakji KG, Sabik JF 3rd, Bhudia SK, Batizy LH, Blackstone EH (2011) Temporal onset, risk factors, and outcomes associated with stroke after coronary artery bypass grafting. JAMA 305:381–390

    Article  PubMed  CAS  Google Scholar 

  25. Racz MJ, Hannan EL, Isom OW, Subramanian VA, Jones RH, Gold JP, Ryan TJ, Hartman A, Culliford AT, Bennett E, Lancey RA, Rose EA (2004) A comparison of short- and long-term outcomes after off-pump and on-pump coronary artery bypass graft surgery with sternotomy. J Am Coll Cardiol 43:557–564

    Article  PubMed  Google Scholar 

  26. Hannan EL, Wu C, Walford G, Culliford AT, Gold JP, Smith CR, Higgins RS, Carlson RE, Jones RH (2008) Drug-eluting stents vs. coronary-artery bypass grafting in multivessel coronary disease. N Engl J Med 358:331–341

    Article  PubMed  CAS  Google Scholar 

  27. van Domburg RT, Lemos PA, Takkenberg JJ, Liu TK, van Herwerden LA, Arampatzis CA, Smits PC, Daemen J, Venema AC, Serruys PW, Bogers AJ (2005) The impact of the introduction of drug-eluting stents on the clinical practice of surgical and percutaneous treatment of coronary artery disease. Eur Heart J 26:675–681

    Article  PubMed  Google Scholar 

  28. Peters RJ, Mehta SR, Fox KA, Zhao F, Lewis BS, Kopecky SL, Diaz R, Commerford PJ, Valentin V, Yusuf S, Clopidogrel in Unstable angina to prevent Recurrent Events (CURE) Trial Investigators (2003) Effects of aspirin dose when used alone or in combination with clopidogrel in patients with acute coronary syndromes: observations from the Clopidogrel in Unstable angina to prevent Recurrent Events (CURE) study. Circulation 108:1682–1687

    Article  PubMed  CAS  Google Scholar 

  29. Hansen ML, Sørensen R, Clausen MT, Fog-Petersen ML, Raunsø J, Gadsbøll N, Gislason GH, Folke F, Andersen SS, Schramm TK, Abildstrøm SZ, Poulsen HE, Køber L, Torp-Pedersen C (2010) Risk of bleeding with single, dual, or triple therapy with warfarin, aspirin, and clopidogrel in patients with atrial fibrillation. Arch Intern Med 170:1433–1441

    Article  PubMed  CAS  Google Scholar 

  30. Setoguchi S, Glynn RJ, Avorn J, Mittleman MA, Levin R, Winkelmayer WC (2008) Improvements in long-term mortality after myocardial infarction and increased use of cardiovascular drugs after discharge: a 10-year trend analysis. J Am Coll Cardiol 51:1247–1254

    Article  PubMed  Google Scholar 

  31. Scheller B (2011) Opportunities and limitations of drug-coated balloons in interventional therapies. Herz 36:232–239

    Article  PubMed  CAS  Google Scholar 

  32. German Institute for the Hospital Remuneration System (InEK) (2010) G-DRG-System 2010: Fallpauschalen-Katalog 2010. http://www.g-drg.de/cms/G-DRG-System_2010/Fallpauschalen-Katalog/Fall-pauschalen-Katalog_2010. Accessed August 30, 2011

  33. Henschke C, Baeumler M, Gaskins M, Busse R (2010) Coronary stents and the uptake of new medical devices in the German system of inpatient reimbursement. J Interven Cardiol 23:546–553

    Article  Google Scholar 

  34. Rote Liste Service GmbH (2010) Rote Liste 2010. Arzneimittelinformationen für Deutschland. Rote Liste Service GmbH, Frankfurt am Main, Germany

  35. Soskuty G (2010) Innovationen in Diagnostik und Therapie: Zugang und Hürden im System. In: Rebscher H, Kaufmann S (eds) Innovationsmanagement in Gesundheitssystemen. Medhochzwei, Heidelberg, pp 159–174

    Google Scholar 

  36. Schweikert B, Hahmann H, Steinacker JM, Imhof A, Muche R, Koenig W, Liu Y, Leidl R (2009) Intervention study shows outpatient cardiac rehabilitation to be economically at least as attractive as inpatient rehabilitation. Clin Res Cardiol 98:787–795

    Article  PubMed  Google Scholar 

  37. Kolominsky-Rabas PL, Heuschmann PU, Marschall D, Emmert M, Baltzer N, Neundörfer B, Schöffski O, Krobot KJ (2006) Lifetime cost of ischemic stroke in Germany: results and national projections from a population-based stroke registry: the Erlangen Stroke Project. Stroke 37:1179–1183

    Article  PubMed  Google Scholar 

  38. Bonaventura K, Sonntag S, Kleber FX (2011) Antiplatelet therapy in the era of percutaneous coronary intervention with drug-eluting balloons. EuroIntervention 7:K106–K111

    Article  PubMed  Google Scholar 

  39. Kleber FX, Mathey DG, Rittger H, Scheller B (2011) On behalf of the German drug-eluting balloon consensus group. How to use the drug-eluting balloon. Recommendations by the German consensus group. EuroIntervention 7:K125–K128

    Article  PubMed  Google Scholar 

  40. Scheller B, Levenson B, Joner M, Zahn R, Klauss V, Naber C, Schächinger V, Elsässer A, Arbeitsgruppe Interventionelle Kardiologie (AGIK) der Deutschen Gesellschaft für Kardiologie (DGK) (2011) Drug-eluting coronary stents and drug-coated balloon catheters. 2011 Position Paper of the German Cardiac Society. Kardiologe 5:411–435

    Article  CAS  Google Scholar 

  41. Mongan JJ, Ferris TG, Lee TH (2008) Options for slowing the growth of health care costs. N Engl J Med 358:1509–1514

    Article  PubMed  CAS  Google Scholar 

  42. Bodenheimer T (2005) High and rising health care costs. Part 2: technologic innovation. Ann Intern Med 142:932–937

    PubMed  Google Scholar 

  43. Cohen DJ, Reynolds MR (2008) Interpreting the results of cost-effectiveness studies. J Am Coll Cardiol 52:2119–2126

    Article  PubMed  Google Scholar 

  44. Glick HA, Doshi JA, Sonnad SS, Polsky D (2007) Sampling uncertainty: calculation, sample size and power, and decision criteria. In: Glick HA, Doshi JA, Sonnad SS, Polsky D (eds) Economic evaluation in clinical trials. Oxford University Press, Oxford, pp 179–206

    Google Scholar 

  45. Bilcke J, Beutels P, Brisson M, Jit M (2011) Accounting for methodological, structural, and parameter uncertainty in decision-analytic models: a practical guide. Med Decis Making 31:675–692

    Article  PubMed  Google Scholar 

  46. Hamm CW, Bassand JP, Agewall S, Bax J, Boersma E, Bueno H, Caso P, Dudek D, Gielen S, Huber K, Ohman M, Petrie MC, Sonntag F, Uva MS, Storey RF, Wijns W, Zahger D, ESC Committee for Practice Guidelines, Bax JJ, Auricchio A, Baumgartner H, Ceconi C, Dean V, Deaton C, Fagard R, Funck-Brentano C, Hasdai D, Hoes A, Knuuti J, Kolh P, McDonagh T, Moulin C, Poldermans D, Popescu BA, Reiner Z, Sechtem U, Sirnes PA, Torbicki A, Vahanian A, Windecker S, Document Reviewers, Windecker S, Achenbach S, Badimon L, Bertrand M, Bøtker HE, Collet JP, Crea F, Danchin N, Falk E, Goudevenos J, Gulba D, Hambrecht R, Herrmann J, Kastrati A, Kjeldsen K, Kristensen SD, Lancellotti P, Mehilli J, Merkely B, Montalescot G, Neumann FJ, Neyses L, Perk J, Roffi M, Romeo F, Ruda M, Swahn E, Valgimigli M, Vrints CJ, Widimsky P (2011) ESC guidelines for the management of acute coronary syndromes in patients presenting without persistent ST-segment elevation: The Task Force for the Management of Acute Coronary Syndromes (ACS) in patients presenting without persistent ST-segment elevation of the European Society of Cardiology (ESC). Eur Heart J (in press)

  47. Neubauer H, Krüger JC, Lask S, Endres HG, Pepinghege F, Engelhardt A, Bulut D, Mügge A (2009) Comparing the antiplatelet effect of clopidogrel hydrogensulfate and clopidogrel besylate: a crossover study. Clin Res Cardiol 98:533–540

    Article  PubMed  CAS  Google Scholar 

  48. Silber S, Borggrefe M, Böhm M, Hoffmeister HM, Dietz R, Ertl G, Heusch G (2008) Drug-eluting coronary stents and drug eluting balloon catheters: summary of the position papers of the DGK. Clin Res Cardiol 97:548–563

    Article  PubMed  Google Scholar 

  49. Weber FD, Schneider H, Wiemer M, Pfannebecker T, Tebbe U, Hamm CW, Senges J, Schneider S, Nienaber CA (2008) Sirolimus eluting stent (Cypher) in patients with diabetes mellitus: results from the German Cypher Stent Registry. Clin Res Cardiol 97:105–109

    Article  PubMed  Google Scholar 

  50. Möllmann H, Elsässer A, Nef H, Schneider S, Nienaber CA, Richardt G, Weber M, Kelm M, Levenson B, Bonzel T, Tebbe U, Sabin G, Pfannebecker T, Senges J, Hamm CW (2008) Treatment of in-stent restenosis with sirolimus-eluting-stents: results from the prospective German Cypher stent registry. Clin Res Cardiol 97:432–440

    Article  PubMed  Google Scholar 

  51. Siller-Matula JM, Tentzeris I, Vogel B, Schacherl S, Jarai R, Geppert A, Unger G, Huber K (2010) Tacrolimus-eluting carbon-coated stents versus sirolimus-eluting stents for prevention of symptom-driven clinical end points. Clin Res Cardiol 99:645–650

    Article  PubMed  CAS  Google Scholar 

  52. Akin I, Bufe A, Schneider S, Reinecke H, Eckardt L, Richardt G, Burska D, Senges J, Kuck KH, Nienaber CA (2010) Clinical outcomes in diabetic and non-diabetic patients with drug-eluting stents: results from the first phase of the prospective multicenter German DES.DE registry. Clin Res Cardiol 99:393–400

    Article  PubMed  CAS  Google Scholar 

Download references

Conflict of interest

K.B. and F.X.K. have received lecture and consulting fees from B. Braun. The remaining authors have no disclosures.

Author information

Authors and Affiliations

Authors

Corresponding author

Correspondence to Klaus Bonaventura.

Rights and permissions

Reprints and permissions

About this article

Cite this article

Bonaventura, K., Leber, A.W., Sohns, C. et al. Cost-effectiveness of paclitaxel-coated balloon angioplasty and paclitaxel-eluting stent implantation for treatment of coronary in-stent restenosis in patients with stable coronary artery disease. Clin Res Cardiol 101, 573–584 (2012). https://doi.org/10.1007/s00392-012-0428-2

Download citation

  • Received:

  • Accepted:

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s00392-012-0428-2

Keywords

Navigation