Skip to main content

Technical Insights on Drug-Coated Balloons

  • Chapter
  • First Online:
Book cover Drug-Coated Balloons
  • 512 Accesses

Abstract

Interventional cardiology has witnessed several revolutionary developments over the last two decades leading to progressive changes in daily practice. The most striking revolution in the percutaneous treatment of coronary artery disease has undoubtedly been the introduction of the drug-eluting stent (DES). Drug-eluting stents made a revolution in interventional cardiology, not only by improving the mechanical limitations of balloon angioplasty but also by radically decreasing restenosis rates [1, 2]. Last-generation DESs have shown to decrease 12-month restenosis rates to single digits; however, concerns still exist regarding the rare but unpredictable occurrence of late or very late stent thrombosis, a catastrophic event resulting from delayed vessel healing [3, 4]. Current guidelines recommend the use of prolonged double antiplatelet therapy (DAPT) following DES implantation which may become problematic in specific clinical settings where a shorter DAPT period is desired (i.e., high-bleeding-risk patients) [5].

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

Access this chapter

Chapter
USD 29.95
Price excludes VAT (USA)
  • Available as PDF
  • Read on any device
  • Instant download
  • Own it forever
eBook
USD 99.00
Price excludes VAT (USA)
  • Available as EPUB and PDF
  • Read on any device
  • Instant download
  • Own it forever
Hardcover Book
USD 129.99
Price excludes VAT (USA)
  • Durable hardcover edition
  • Dispatched in 3 to 5 business days
  • Free shipping worldwide - see info

Tax calculation will be finalised at checkout

Purchases are for personal use only

Institutional subscriptions

References

  1. Fischman DL, et al. A randomized comparison of coronary-stent placement and balloon angioplasty in the treatment of coronary artery disease. Stent restenosis study investigators. N Engl J Med. 1994;331(8):496–501.

    Article  CAS  Google Scholar 

  2. Holmes DR Jr, et al. Restenosis after percutaneous transluminal coronary angioplasty (PTCA): a report from the PTCA Registry of the National Heart, Lung, and Blood Institute. Am J Cardiol. 1984;53(12):77c–81c.

    Article  Google Scholar 

  3. Nakazawa G, et al. One step forward and two steps back with drug-eluting-stents: from preventing restenosis to causing late thrombosis and nouveau atherosclerosis. JACC Cardiovasc Imaging. 2009;2(5):625–8.

    Article  Google Scholar 

  4. Finn AV, et al. Vascular responses to drug eluting stents: importance of delayed healing. Arterioscler Thromb Vasc Biol. 2007;27(7):1500–10.

    Article  CAS  Google Scholar 

  5. Valgimigli M, et al. 2017 ESC focused update on dual antiplatelet therapy in coronary artery disease developed in collaboration with EACTS: the task force for dual antiplatelet therapy in coronary artery disease of the European Society of Cardiology (ESC) and of the European Association for Cardio-Thoracic Surgery (EACTS). Eur Heart J. 2018;39(3):213–60.

    Article  Google Scholar 

  6. Goldman B, Blanke H, Wolinsky H. Influence of pressure on permeability of normal and diseased muscular arteries to horseradish peroxidase. A new catheter approach. Atherosclerosis. 1987;65(3):215–25.

    Article  CAS  Google Scholar 

  7. Cremers B, et al. Drug-eluting balloon: very short-term exposure and overlapping. Thromb Haemost. 2009;101(1):201–6.

    Article  CAS  Google Scholar 

  8. Wessely R, et al. Comparative characterization of cellular and molecular anti-restenotic profiles of paclitaxel and sirolimus. Implications for local drug delivery. Thromb Haemost. 2007;97(6):1003–12.

    Article  CAS  Google Scholar 

  9. Dangas GD, et al. Meta-analysis of everolimus-eluting versus paclitaxel-eluting stents in coronary artery disease: final 3-year results of the SPIRIT clinical trials program (Clinical Evaluation of the Xience V Everolimus Eluting Coronary Stent System in the Treatment of Patients With De Novo Native Coronary Artery Lesions). JACC Cardiovasc Interv. 2013;6(9):914–22.

    Article  Google Scholar 

  10. Edelman ER, Adams DH, Karnovsky MJ. Effect of controlled adventitial heparin delivery on smooth muscle cell proliferation following endothelial injury. Proc Natl Acad Sci U S A. 1990;87(10):3773–7.

    Article  CAS  Google Scholar 

  11. Muller DW, et al. Intramural methotrexate therapy for the prevention of neointimal thickening after balloon angioplasty. J Am Coll Cardiol. 1992;20(2):460–6.

    Article  CAS  Google Scholar 

  12. Gradus-Pizlo I, et al. Local delivery of biodegradable microparticles containing colchicine or a colchicine analogue: effects on restenosis and implications for catheter-based drug delivery. J Am Coll Cardiol. 1995;26(6):1549–57.

    Article  CAS  Google Scholar 

  13. Scheller B, et al. Acute cardiac tolerance of current contrast media and the new taxane protaxel using iopromide as carrier during porcine coronary angiography and stenting. Investig Radiol. 2002;37(1):29–34.

    Article  CAS  Google Scholar 

  14. Scheller B, et al. Paclitaxel balloon coating, a novel method for prevention and therapy of restenosis. Circulation. 2004;110(7):810–4.

    Article  CAS  Google Scholar 

  15. Rowinsky EK, Donehower RC. Paclitaxel (taxol). N Engl J Med. 1995;332(15):1004–14.

    Article  CAS  Google Scholar 

  16. Granada JF, et al. Mechanisms of tissue uptake and retention of paclitaxel-coated balloons: impact on neointimal proliferation and healing. Open Heart. 2014;1(1):e000117.

    Article  Google Scholar 

  17. Kelsch B, et al. Dose response to Paclitaxel-coated balloon catheters in the porcine coronary overstretch and stent implantation model. Investig Radiol. 2011;46(4):255–63.

    Article  CAS  Google Scholar 

  18. Berg MC, et al. Drug-coated angioplasty balloon catheters: coating compositions and methods. Adv Eng Mater. 2012;14:B45–50.

    Article  Google Scholar 

  19. Cremers B, et al. Comparison of two different paclitaxel-coated balloon catheters in the porcine coronary restenosis model. Clin Res Cardiol. 2009;98(5):325–30.

    Article  CAS  Google Scholar 

  20. Yeh TK, et al. Formulating paclitaxel in nanoparticles alters its disposition. Pharm Res. 2005;22(6):867–74.

    Article  CAS  Google Scholar 

  21. Radke PW, et al. Vascular effects of paclitaxel following drug-eluting balloon angioplasty in a porcine coronary model: the importance of excipients. EuroIntervention. 2011;7(6):730–7.

    Article  Google Scholar 

  22. Kempin W, et al. In vitro evaluation of paclitaxel coatings for delivery via drug-coated balloons. Eur J Pharm Biopharm. 2015;96:322–8.

    Article  CAS  Google Scholar 

  23. Axel DI, et al. Paclitaxel inhibits arterial smooth muscle cell proliferation and migration in vitro and in vivo using local drug delivery. Circulation. 1997;96(2):636–45.

    Article  CAS  Google Scholar 

  24. Katsanos K, et al. Systematic review and meta-analysis of randomized controlled trials of paclitaxel-coated balloon angioplasty in the femoropopliteal arteries: role of paclitaxel dose and bioavailability. J Endovasc Ther. 2016;23(2):356–70.

    Article  Google Scholar 

  25. Kolodgie FD, et al. Comparison of particulate embolization after femoral artery treatment with IN.PACT Admiral versus Lutonix 035 paclitaxel-coated balloons in healthy swine. J Vasc Interv Radiol. 2016;27(11):1676–1685.e2.

    Article  Google Scholar 

  26. Gongora CA, et al. Impact of paclitaxel dose on tissue pharmacokinetics and vascular healing: a comparative drug-coated balloon study in the familial hypercholesterolemic swine model of superficial femoral in-stent restenosis. JACC Cardiovasc Interv. 2015;8(8):1115–23.

    Article  Google Scholar 

  27. Milewski K, et al. Evaluation of efficacy and dose response of different paclitaxel-coated balloon formulations in a novel swine model of iliofemoral in-stent restenosis. JACC Cardiovasc Interv. 2012;5(10):1081–8.

    Article  Google Scholar 

  28. Yazdani SK, et al. Vascular, downstream, and pharmacokinetic responses to treatment with a low dose drug-coated balloon in a swine femoral artery model. Catheter Cardiovasc Interv. 2014;83(1):132–40.

    Article  Google Scholar 

  29. Rosenfield K, et al. Trial of a paclitaxel-coated balloon for femoropopliteal artery disease. N Engl J Med. 2015;373(2):145–53.

    Article  CAS  Google Scholar 

  30. Schneider PA, et al. Treatment effect of drug-coated balloons is durable to 3 years in the femoropopliteal arteries: long-term results of the IN.PACT SFA randomized trial. Circ Cardiovasc Interv. 2018;11(1):e005891.

    Article  Google Scholar 

  31. Kedhi E, et al. Second-generation everolimus-eluting and paclitaxel-eluting stents in real-life practice (COMPARE): a randomised trial. Lancet. 2010;375(9710):201–9.

    Article  CAS  Google Scholar 

  32. Stone GW, et al. Everolimus-eluting versus paclitaxel-eluting stents in coronary artery disease. N Engl J Med. 2010;362(18):1663–74.

    Article  CAS  Google Scholar 

  33. Buszman PP, et al. Stent healing response following delivery of paclitaxel via durable polymeric matrix versus iopromide-based balloon coating in the familial hypercholesterolaemic swine model of coronary injury. EuroIntervention. 2013;9(4):510–6.

    Article  Google Scholar 

Download references

Author information

Authors and Affiliations

Authors

Corresponding author

Correspondence to Juan F. Granada .

Editor information

Editors and Affiliations

Rights and permissions

Reprints and permissions

Copyright information

© 2019 Springer Nature Switzerland AG

About this chapter

Check for updates. Verify currency and authenticity via CrossMark

Cite this chapter

Ferrone, M., Granada, J.F. (2019). Technical Insights on Drug-Coated Balloons. In: Cortese, B. (eds) Drug-Coated Balloons . Springer, Cham. https://doi.org/10.1007/978-3-319-92600-1_5

Download citation

  • DOI: https://doi.org/10.1007/978-3-319-92600-1_5

  • Published:

  • Publisher Name: Springer, Cham

  • Print ISBN: 978-3-319-92599-8

  • Online ISBN: 978-3-319-92600-1

  • eBook Packages: MedicineMedicine (R0)

Publish with us

Policies and ethics