Skip to main content
SpringerLink
Log in

Technical Insights on Drug-Coated Balloons II

  • Chapter
  • First Online:
Drug-Coated Balloons

Abstract

The drug-coated balloon is a future treatment device which leaves nothing behind. It delivers the drug in a very short time and provides long-term release of the drug to treat posttreatment shortcomings. Currently paclitaxel and sirolimus are the only choices for drug-coated balloons. Preclinical study findings on paclitaxel are mixed and depend on various factors such as the drug carrier, balloon surface, drug size, coating method etc. The sirolimus-coated balloon is an emerging device and based on certain preclinical reports, it has generated new hope for safe and effective drug delivery.

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

Access this chapter

Log in via an institution
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. Tepe G, Zeller T, Albrecht T, Heller S, Schwarzwälder U, Beregi JP, Claussen CD, Oldenburg A, Scheller B, Speck U. Local delivery of paclitaxel to inhibit restenosis during angioplasty of the leg. N Engl J Med. 2008;358:689–99. https://doi.org/10.1056/NEJMoa0706356.

    Article  CAS  PubMed  Google Scholar 

  2. Werk M, Langner S, Reinkensmeier B, Boettcher HF, Tepe G, Dietz U, Hosten N, Hamm B, Speck U, Ricke J. Inhibition of restenosis in femoropopliteal arteries: paclitaxel-coated versus uncoated balloon: femoral paclitaxel randomized pilot trial. Circulation. 2008;118:1358–65. https://doi.org/10.1161/CIRCULATIONAHA.107.735985.

    Article  CAS  PubMed  Google Scholar 

  3. Tepe G, Laird J, Schneider P, Brodmann M, Krishnan P, Micari A, Metzger C, Scheinert D, Zeller T, Cohen DJ, Snead DB, Alexander B, Landini M, Jaff MR, IN.PACT SFA Trial Investigators. Drug-coated balloon versus standard percutaneous transluminal angioplasty for the treatment of superficial femoral and popliteal peripheral artery disease: 12-month results from the IN.PACT SFA randomized trial. Circulation. 2015;131:495–502. https://doi.org/10.1161/CIRCULATIONAHA.114.011004.

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  4. Cortese B, Granada JF, Scheller B, Schneider PA, Tepe G, Scheinert D, Garcia L, Stabile E, Alfonso F, Ansel G, Zeller T. Drug-coated balloon treatment for lower extremity vascular disease intervention: an international positioning document. Eur Heart J. 2016;37(14):1096–103. https://doi.org/10.1093/eurheartj/ehv204.

    Article  PubMed  Google Scholar 

  5. Scheller B, Hehrlein C, Bocksch W, Rutsch W, Haghi D, Dietz U, Böhm M, Speck U. Treatment of coronary in-stent restenosis with a paclitaxel coated balloon catheter. N Engl J Med. 2006;355:2113–24. https://doi.org/10.1056/NEJMoa061254.

    Article  CAS  PubMed  Google Scholar 

  6. Scheller B, Clever YP, Kelsch B, Hehrlein C, Bocksch W, Rutsch W, Haghi D, Dietz U, Speck U, Böhm M, Cremers B. Long-term follow-up after treatment of coronary in-stent restenosis with a paclitaxel-coated balloon catheter. JACC Cardiovasc Interv. 2012;5:323–30. https://doi.org/10.1016/j.jcin.2012.01.008.

    Article  PubMed  Google Scholar 

  7. 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. Paclitaxel-coated balloon catheter versus paclitaxel-coated stent for the treatment of coronary in-stent restenosis. Circulation. 2009;119:2986–94. https://doi.org/10.1161/CIRCULATIONAHA.108.839282.

    Article  CAS  PubMed  Google Scholar 

  8. Rittger H, Brachmann J, Sinha AM, Waliszewski M, Ohlow M, Brugger A, Thiele H, Birkemeyer R, Kurowski V, Breithardt OA, Schmidt M, Zimmermann S, Lonke S, von Cranach M, Nguyen TV, Daniel WG, Wöhrle J. A randomized, multicenter, single-blinded trial comparing paclitaxel-coated balloon angioplasty with plain balloon angioplasty in drug-eluting stent restenosis: the PEPCAD-DES study. J Am Coll Cardiol. 2012;59:1377–82. https://doi.org/10.1016/j.jacc.2012.01.015.

    Article  CAS  PubMed  Google Scholar 

  9. Habara S, Mitsudo K, Kadota K, Goto T, Fujii S, Yamamoto H, Katoh H, Oka N, Fuku Y, Hosogi S, Hirono A, Maruo T, Tanaka H, Shigemoto Y, Hasegawa D, Tasaka H, Kusunose M, Otsuru S, Okamoto Y, Saito N, Tsujimoto Y, Eguchi H, Miyake K, Yoshino M. Effectiveness of paclitaxel-eluting balloon catheter in patients with sirolimus-eluting stent restenosis. JACC Cardiovasc Interv. 2011;4:149–54. https://doi.org/10.1016/j.jcin.2010.10.012.

    Article  PubMed  Google Scholar 

  10. Byrne RA, Neumann FJ, Mehilli J, Pinieck S, Wolff B, Tiroch K, Schulz S, Fusaro M, Ott I, Ibrahim T, Hausleiter J, Valina C, Pache J, Laugwitz KL, Massberg S, Kastrati A, ISAR-DESIRE 3 investigators. Paclitaxel-eluting balloons, paclitaxel-eluting stents, and balloon angioplasty in patients with restenosis after implantation of a drug-eluting stent (ISAR-DESIRE 3): a randomised, open-label trial. Lancet. 2013;381:461–7. https://doi.org/10.1016/S0140-6736(12)61964-3.

    Article  CAS  PubMed  Google Scholar 

  11. Liistro F, Porto I, Angioli P, Grotti S, Ricci L, Ducci K, Falsini G, Ventoruzzo G, Turini F, Bellandi G, Bolognese L. Drug-eluting balloon in peripheral intervention for below the knee angioplasty evaluation (DEBATE-BTK): a randomized trial in diabetic patients with critical limb ischemia. Circulation. 2013;128:615–21. https://doi.org/10.1161/CIRCULATIONAHA.113.001811.

    Article  CAS  PubMed  Google Scholar 

  12. Speck U, Cremers B, Kelsch B, Biedermann M, Clever YP, Schaffner S, Mahnkopf D, Hanisch U, Böhm M, Scheller B. Do pharmacokinetics explain persistent restenosis inhibition by a single dose of paclitaxel? Circ Cardiovasc Interv. 2012;5:392–400. https://doi.org/10.1161/CIRCINTERVENTIONS.111.967794.

    Article  CAS  PubMed  Google Scholar 

  13. Granada JF, Tellez A, Baumbach WR, Bingham B, Keng YF, Wessler J, Conditt G, McGregor J, Stone G, Kaluza GL, Leon MB. In vivo delivery and long-term tissue retention of nano-encapsulated sirolimus using a novel porous balloon angioplasty system. EuroIntervention. 2016;12(6):740–7. https://doi.org/10.4244/EIJY16M10_01.

    Article  PubMed  Google Scholar 

  14. Cremers B, Toner JL, Schwartz LB, von Oepen R, Speck U, Kaufels N, Clever YP, Mahnkopf D, Böhm M, Scheller B. Inhibition of neointimal hyperplasia with a novel zotarolimus coated balloon catheter. Clin Res Cardiol. 2012;101:469–76. https://doi.org/10.1007/s00392-012-0415-7.

    Article  CAS  PubMed  Google Scholar 

  15. Carter AJ, Aggarwal M, Kopia GA, Tio F, Tsao PS, Kolata R, Yeung AC, Llanos G, Dooley J, Falotico R. Long-term effects of polymer-based, slow-release, sirolimus-eluting stents in a porcine coronary model. Cardiovasc Res. 2004;63:617–24. https://doi.org/10.1016/j.cardiores.2004.04.029.

    Article  CAS  PubMed  Google Scholar 

  16. Marx SO, Marks AR. Bench to bedside: the development of rapamycin and its application to stent restenosis. Circulation. 2001;104:852–5.

    Article  CAS  PubMed  Google Scholar 

  17. Birkmeier KA, Kastrati A, Byrne RA, Holle H, Schulz S, Tiroch K, et al. Five-year clinical outcomes of sirolimus-eluting versus paclitaxel-eluting stents in high-risk patients. Catheter Cardiovasc Interv. 2011;77:494–501.

    Article  PubMed  Google Scholar 

  18. Cortese B, Bertoletti A. Paclitaxel coated balloons for coronary artery interventions: a comprehensive review of preclinical and clinical data. Int J Cardiol. 2012;161:4–12.

    Article  PubMed  Google Scholar 

  19. Speck U, Scheller B, Abramjuk C, et al. Neointima inhibition: comparison of effectiveness of non-stent-based local drug delivery and a drug eluting stent in porcine coronary arteries. Radiology. 2006;240:411–8.

    Article  PubMed  Google Scholar 

  20. Albrecht T, Speck U, Baier C, et al. Reduction of stenosis due to intimal hyperplasia after stent supported angioplasty of peripheral arteries by local administration of paclitaxel in swine. Invest Radiol. 2007;42:579–85.

    Article  CAS  PubMed  Google Scholar 

  21. Posa A, Nyolczas N, Hemetsberger R, Pavo N, Petnehazy O, Petrasi Z, et al. Optimization of drug-eluting balloon use for safety and efficacy: evaluation of the 2nd generation paclitaxel-eluting DIOR-balloon in porcine coronary arteries. Catheter Cardiovasc Interv. 2010;76(3):395–403.

    Article  PubMed  Google Scholar 

  22. Belkacemi A, Agostoni P, Voskuil M, Doevendans P, Stella P. Drug-eluting balloons in coronary artery disease — current and future perspectives. Eur Cardiol. 2012;8:56–9.

    Article  Google Scholar 

  23. Xiong GM, Ang H, Lin J, Lui YS, Phua JL, Chan JN, et al. Materials technology in drug eluting balloons: current and future perspectives. J Control Release. 2016;239:92–106.

    Article  CAS  PubMed  Google Scholar 

  24. Peterson S, Hasenbank M, Silvestro C, Raina S. IN.PACT™ Admiral™ drug-coated balloon: durable, consistent and safe treatment for femoropopliteal peripheral artery disease. Adv Drug Deliv Rev. 2016;112:69–77.

    Article  PubMed  Google Scholar 

  25. Micari A, Cioppa A, Vadala G, Stabile E, Castriota F, Pantaleo P, et al. A new paclitaxel-eluting balloon for angioplasty of femoropopliteal obstructions: acute and midterm results. EuroIntervention. 2011;7(Suppl K):K77–82.

    Article  PubMed  Google Scholar 

  26. Radke P, Joner M, Joost A, Byrne R, Hartwig S, Bayer G, Steigerwald K, Wittchow E. Vascular effects of paclitaxel following drug-eluting balloon angioplasty in a porcine coronary model: the importance of excipient. EuroIntervention. 2011;7(6):730–7.

    Article  PubMed  Google Scholar 

  27. Cheng Y, Shibuya M, McGregor J, Conditt G, Yi G-H, Kaluza G, Gray W, Doshi M, Sojitra P, Granada J. Biological effect on restenosis and vascular healing of encapsulated paclitaxel nanocrystals delivered via coated balloon technology in the familial hypercholesterolaemic swine model of in-stent restenosis. EuroIntervention. 2016;12(9):1164–73.

    Article  PubMed  Google Scholar 

  28. Lemos Neto PA, Farooq V, Takimura CK, Gutierrez PS, Virmani R, Kolodgie F, et al. Emerging technologies: polymer-free phospholipid encapsulated sirolimus nanocarriers for the controlled release of drug from a stent-plus-balloon or a stand-alone balloon catheter. EuroIntervention. 2013;9(1):146–56. https://doi.org/10.4244/EIJV9I1A21.

    Article  Google Scholar 

  29. Takimura CK, Galon MZ, Sojitra P, Doshi M, Aiello V, Gutierrez PS, Carvalho J, Ferreira SK, Chaves MJF, Laurindo FRM, Lemos PA. Excipient:drug dose determination for neointimal hyperplasia as assessed by optical coherence tomography and histopathology in porcine coronary arteries after sirolimus-eluting balloon deployment. Rev Bras Cardiol Invasiva. 2012;20(2):133–9.

    Google Scholar 

  30. Slagboom T, Amoroso G, Jensen LO, Granada JF, Stella P. The SABRE trial (Sirolimus Angioplasty Balloon for Coronary In-Stent Restenosis): angiographic results and 1-year clinical outcomes. JACC Cardiovasc Interv. 2017;10(20):2029–37.

    Article  PubMed  Google Scholar 

  31. Bersin RM. Update on sirolimus coated balloon technologies. In: Cardiovascular Research Technologies (CRT 17), Washington, DC, 18–21 Feb 2017.

    Google Scholar 

  32. Mori T, Kinoshita Y, Watanabe A, Yamaguchi T, Hosokawa K, Honjo H. Retention of paclitaxel in cancer cells for 1 week in vivo and in vitro. Cancer Chemother Pharmacol. 2006;58(5):665–72.

    Article  CAS  PubMed  Google Scholar 

  33. Scheller B, Speck U, Abramjuk C, Bernhardt U, Bohm M, Nickenig G. Paclitaxel balloon coating, a novel method for prevention and therapy of restenosis. Circulation. 2004;110(7):810–4.

    Article  CAS  PubMed  Google Scholar 

  34. Rowinsky EK, Donehower RC. Paclitaxel (taxol). N Engl J Med. 1995;332:1004–14. https://doi.org/10.1056/NEJM199504133321507.

    Article  CAS  PubMed  Google Scholar 

  35. Levin AD, Vukmirovic N, Hwang CW, Edelman ER. Specific binding to intracellular proteins determines arterial transport properties for rapamycin and paclitaxel. Proc Natl Acad Sci U S A. 2004;101:9463–7. https://doi.org/10.1073/pnas.0400918101.

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  36. Alfonso F, Pérez-Vizcayno MJ, Cárdenas A, García Del Blanco B, Seidelberger B, Iñiguez A, Gómez-Recio M, Masotti M, Velázquez MT, Sanchís J, García-Touchard A, Zueco J, Bethencourt A, Melgares R, Cequier A, Dominguez A, Mainar V, López-Mínguez JR, Moreu J, Martí V, Moreno R, Jiménez-Quevedo P, Gonzalo N, Fernández C, Macaya C, RIBS V Study Investigators, under the auspices of the Working Group on Interventional Cardiology of the Spanish Society of Cardiology. A randomized comparison of drug-eluting balloon versus everolimus-eluting stent in patients with bare-metal stent-in-stent restenosis: the RIBS V Clinical Trial (Restenosis Intra-stent of Bare Metal Stents: paclitaxel-eluting balloon vs. everolimus-eluting stent). J Am Coll Cardiol. 2014;63:1378–86. https://doi.org/10.1016/j.jacc.2013.12.006.

    Article  CAS  PubMed  Google Scholar 

Download references

Author information

Authors and Affiliations

  1. Concept Medical Research Private Limited, Surat, India

    Manish Doshi & Prakash Sojitra

  2. William Beaumont Hospital, Royal Oak, MI, USA

    Dinesh Shah

  3. Apollo Hospitals, Ahmedabad, India

    Sameer Dani

  4. Instituto Dante Pazzanese de Cardiologia, Sao Paulo, Brazil

    Alexandre Abizaid

Authors
  1. Manish Doshi
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Prakash Sojitra
    View author publications

    You can also search for this author in PubMed Google Scholar

  3. Dinesh Shah
    View author publications

    You can also search for this author in PubMed Google Scholar

  4. Sameer Dani
    View author publications

    You can also search for this author in PubMed Google Scholar

  5. Alexandre Abizaid
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to Prakash Sojitra .

Editor information

Editors and Affiliations

  1. Cardiac Department, San Carlo Clinic, Milano, Italy

    Bernardo Cortese

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

Doshi, M., Sojitra, P., Shah, D., Dani, S., Abizaid, A. (2019). Technical Insights on Drug-Coated Balloons II. In: Cortese, B. (eds) Drug-Coated Balloons . Springer, Cham. https://doi.org/10.1007/978-3-319-92600-1_6

Download citation

  • DOI: https://doi.org/10.1007/978-3-319-92600-1_6

  • 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

Search

Navigation