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Drug-Coated Balloons in Native Coronary Artery Disease

  • Mostafa Elwany
  • Bernardo Cortese
Chapter

Abstract

The advent of drug-eluting stent (DES) technology for the treatmentofcoronary artery disease (CAD) has significantly reduced the problem of in-stent restenosis caused by neointimal hyperplasia. Some of the limitations of DES include treatment of small vessel disease, issues related to the duration of dual antiplatelet therapy (DAPT), and treatment failure leading to restenosis and late or very late stent thrombosis, especially in complex lesions subsets such as bifurcation lesions. In this light, drug-coated balloons (DCBs) represent an innovation with a high potential impact on the treatment of patients with CAD [1].

References

  1. 1.
    Cortese B, Bertoletti A. Paclitaxel coated balloons for coronary artery interventions: a comprehensive review of preclinical and clinical data. Int J Cardiol. 2012;161(1):4–12.CrossRefGoogle Scholar
  2. 2.
    Belkacemi A, Agostoni P, Voskuil M, Stella PR. Coronary bifurcation lesions treated with the drug-eluting balloon: a preliminary insight from the DEBIUT study. EuroIntervention. 2011;7:K66–9.CrossRefGoogle Scholar
  3. 3.
    Stella PR, Belkacemi A, Dubois C, et al. A multicenter randomized comparison of drug-eluting balloon plus bare-metal stent versus bare-metal stent versus drug-eluting stent in bifurcation lesions treated with a single-stenting technique: six-month angiographic and 12-month clinical results of the drug-eluting balloon in bifurcations trial. Catheter Cardiovasc Interv. 2012;80(7):1138–46.CrossRefGoogle Scholar
  4. 4.
    Schulz A, Hauschild T, Kleber FX. Treatment of coronary de novo bifurcation lesions with DCB only strategy. Clin Res Cardiol. 2014;103(6):451–6.CrossRefGoogle Scholar
  5. 5.
    Mínguez L, Ramón J, Asensio N, Manuel J, Vecino D, Javier L, et al. A prospective randomised study of the paclitaxel-coated balloon catheter in bifurcated coronary lesions (BABILON trial): 24-month clinical and angiographic results. EuroIntervention. 2014;10(1):50–7.CrossRefGoogle Scholar
  6. 6.
    Waksman R, Serra A, Loh JP, et al. Drug-coated balloons for de novo coronary lesions: results from the valentines II trial. EuroIntervention. 2013;9(5):613–9.CrossRefGoogle Scholar
  7. 7.
    Worthley S, Hendriks R, Worthley M, et al. Paclitaxel-eluting balloon and everolimus-eluting stent for provisional stenting of coronary bifurcations: 12-month results of the multicenter BIOLUX-I study. Cardiovasc Revasc Med. 2015;16(7):413–7.CrossRefGoogle Scholar
  8. 8.
    Berland J, Lefèvre T, Brenot P, Fajadet J. DANUBIO–a new drug-eluting balloon for the treatment of side branches in bifurcation lesions: six-month angiographic follow-up results of the DEBSIDE trial. EuroIntervention. 2015;11(8):868–76.CrossRefGoogle Scholar
  9. 9.
    Jim M-H, Lee M K-y, Fung R C-y, et al. Six month angiographic result of supplementary paclitaxel-eluting balloon deployment to treat side branch ostium narrowing (SARPEDON). Int J Cardiol. 2015;187:594–7.CrossRefGoogle Scholar
  10. 10.
    Cortese B, Berti S, Biondi-Zoccai G, et al. Drug-coated balloon treatment of coronary artery disease: a position paper of the Italian Society of Interventional Cardiology. Catheter Cardiovasc Interv. 2014;83(3):427–35.CrossRefGoogle Scholar
  11. 11.
    Kleber FX, Mathey DG, Rittger H, et al. How to use the drug-eluting balloon: recommendations by the German consensus group. EuroIntervention. 2011;7:K125–8.CrossRefGoogle Scholar
  12. 12.
    Picard F, Doucet S, Asgar AW. Contemporary use of drug-coated balloons in coronary artery disease: where are we now? Arch Cardiovasc Dis. 2017;110(4):259–72.CrossRefGoogle Scholar
  13. 13.
    Cortese B. The PICCOLETO study and beyond. EuroIntervention. 2011;7:K53–6.CrossRefGoogle Scholar
  14. 14.
    Bondesson P, Lagerqvist B, James SK, et al. Comparison of two drug-eluting balloons: a report from the SCAAR registry. EuroIntervention. 2012;8(4):444–9.CrossRefGoogle Scholar
  15. 15.
    Unverdorben M, Kleber FX, Heuer H, et al. Treatment of small coronary arteries with a paclitaxel-coated balloon catheter in the PEPCAD I study: are lesions clinically stable from 12 to 36 months? EuroIntervention. 2013;9(5):620–8.CrossRefGoogle Scholar
  16. 16.
    Zeymer U, Waliszewski M, Spiecker M, et al. Prospective ‘real world’ registry for the use of the ‘PCB only’ strategy in small vessel de novo lesions. Heart. 2013;100(4):311–6.CrossRefGoogle Scholar
  17. 17.
    Cortese B, Fetiveau R, Carrera A, et al. TCT-417 treatment of coronary artery disease with a new-generation drug-coated balloon: preliminary results from the Italian Elutax SV registry. J Am Coll Cardiol. 2015;15(66):B169–70.CrossRefGoogle Scholar
  18. 18.
    Teo LYL, Khurana R, Jafary FH, Ooi YW. Clinical efficacy and safety of sequent please paclitaxel-eluting balloon in a real-world multi-center registry of south-east Asian patients. Am J Cardiol. 2013;111(7):28B.Google Scholar
  19. 19.
    Uhlemann M, Möbius-Winkler S, Adam J, et al. The Leipzig prospective drug-eluting balloon-registry—outcome of 484 consecutive patients treated for coronary in-stent restenosis and De novo lesions using paclitaxel-coated balloons. Circ J. 2016;80(2):379–86.CrossRefGoogle Scholar
  20. 20.
    Latib A, Colombo A, Castriota F, et al. A randomized multicenter study comparing a paclitaxel drug-eluting balloon with a paclitaxel-eluting stent in small coronary vessels: the BELLO (balloon elution and late loss optimization) study. J Am Coll Cardiol. 2012;60(24):2473–80.CrossRefGoogle Scholar
  21. 21.
    Latib A, Ruparelia N, Menozzi A, et al. 3-year follow-up of the balloon elution and late loss optimization study (BELLO). J Am Coll Cardiol Interv. 2015;8(8):1132–4.CrossRefGoogle Scholar
  22. 22.
    Richelsen RKB, Overvad TF, Jensen SE. Drug-eluting balloons in the treatment of coronary De novo lesions: a comprehensive review. Cardiol Ther. 2016;5(2):133–60.CrossRefGoogle Scholar
  23. 23.
    Cortese B, D’Ascenzo F, Fetiveau R, et al. Treatment of coronary artery disease with a new-generation drug-coated balloon: final results of the Italian Elutax SV rEgistry-DCB-RISE. J Cardiovasc Med (Hagerstown). 2018;19(5):247–52.CrossRefGoogle Scholar
  24. 24.
    Giannini F, Naim C, Costopoulos C, et al. Drug-coated balloons in interventional cardiology. Expert Rev Cardiovasc Ther. 2013;11(10):1379–91.CrossRefGoogle Scholar
  25. 25.
    Belkacemi A, Agostoni P, Nathoe HM, et al. First results of the DEB-AMI (drug eluting balloon in acute ST-segment elevation myocardial infarction) trial. J Am Coll Cardiol. 2012;59(25):2327–37.CrossRefGoogle Scholar
  26. 26.
    Nijhoff F, Agostoni P, Belkacemi A, et al. Primary percutaneous coronary intervention by drug-eluting balloon angioplasty: the nonrandomized fourth arm of the DEB-AMI (drug-eluting balloon in ST-segment elevation myocardial infarction) trial. Catheter Cardiovasc Interv. 2015;86(S1):S34–44.CrossRefGoogle Scholar
  27. 27.
    Vos NS, van der Schaaf RJ, Amoroso G, et al. REVascularization with paclitaxEL-coated balloon angioplasty versus drug-eluting stenting in acute myocardial infarcTION—A randomized controlled trial: rationale and design of the REVELATION trial. Catheter Cardiovasc Interv. 2016;87(7):1213–21.CrossRefGoogle Scholar
  28. 28.
    Gao L, Chen Y-D. Application of drug-coated balloon in coronary artery intervention: challenges and opportunities. J Geriatr Cardiol. 2016;13(11):906–13.PubMedPubMedCentralGoogle Scholar
  29. 29.
    Waksman R, Pakala R. Drug-eluting balloon: the comeback kid? Circ Cardiovasc Interv. 2009;2(4):352–8.CrossRefGoogle Scholar
  30. 30.
    Calé R, Sousa PJ, Pereira E, et al. One-year clinical outcomes of percutaneous treatment with drug-eluting balloons: results from a multicenter registry. Rev Port Cardiol. 2013;32(5):361–9.CrossRefGoogle Scholar
  31. 31.
    Maier LS, Maack C, Ritter O, Böhm M. Hotline update of clinical trials and registries presented at the German Cardiac Society meeting 2008. (PEPCAD, LokalTax, INH, German ablation registry, German device registry, DES.DE registry, DHR, reality, SWEETHEART registry, ADMA, GERSHWIN). Clin Res Cardiol. 2008;97(6):356–63.CrossRefGoogle Scholar
  32. 32.
    Xiu PY, Meier P. What are the barriers to the use of drug-eluting balloons? Interv Cardiol. 2014;6(1):9.CrossRefGoogle Scholar
  33. 33.
    Cortese B, Silva Orrego P, Agostoni P, et al. Effect of drug-coated balloons in native coronary artery disease left with a dissection. J Am Coll Cardiol Intv. 2015;8(15):2003–9.CrossRefGoogle Scholar
  34. 34.
    Wickramarachchi U, Eccleshall S. Drug-coated balloon-only angioplasty for native coronary disease instead of stents. Interv Cardiol Rev. 2016;11(2):110–5.Google Scholar
  35. 35.
    Raban V, Ahmed F, Ohlow MA, et al. Drug-coated balloons for small coronary artery disease (BASKET-SMALL 2): an open-label randomised non-inferiority trial. Lancet. 2018;6736(18):31719–7.Google Scholar

Copyright information

© Springer Nature Switzerland AG 2019

Authors and Affiliations

  • Mostafa Elwany
    • 1
  • Bernardo Cortese
    • 2
  1. 1.Department of Cardiology, Faculty of MedicineAlexandria UniversityAlexandriaEgypt
  2. 2.Cardiac DepartmentSan Carlo ClinicMilanoItaly

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