Skip to main content

Advertisement

SpringerLink
Log in

Advances in Percutaneous Therapies for Peripheral Artery Disease: Drug-Coated Balloons

  • Peripheral Vascular Disease (CJ Cooper and R Gupta, Section Editors)
  • Published:
Current Cardiology Reports Aims and scope Submit manuscript

Abstract

Purpose of Review

This review paper provides a summary on the use of drug-coated balloons in peripheral artery disease. It covers the main drug-coated balloon (DCB) trials. It is divided into categories of lesions: superficial femoral artery and popliteal lesions, infra-popliteal lesions and in-stent restenosis. It also includes an overview of the future of DCBs, highlighting the main ongoing trials.

Recent Findings

The latest research on DCB focuses on newer types of DCBs, mainly paclitaxel-coated but with lower doses. Another area of latest DCB research is its use in superficial femoral artery and popliteal artery in-stent restenosis, with superior outcomes.

Summary

Drug-coated balloons produce better outcomes than percutaneous transluminal angioplasty alone in de novo and in-stent restenosis lesions of superficial femoral artery and popliteal arteries. More data are needed to demonstrate efficacy and safety of DCBs in infrapopliteal disease. Newer DCBs and adjunctive therapy may provide improved outcomes for peripheral artery disease interventions.

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

Access this article

Log in via an institution

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

Similar content being viewed by others

References

Papers of particular interest, published recently, have been highlighted as: •Of importance ••Of major importance

  1. Hirsch AT, Haskal ZJ, Hertzer NR, et al. ACC/AHA guidelines for the management of patients with peripheral arterial disease (lower extremity, renal, mesenteric, and abdominal aortic): a collaborative report from the American Associations for Vascular Surgery/Society for Vascular Surgery, Society for Cardiovascular Angiography and Interventions, Society for Vascular Medicine, Society of Interventional Radiology, and the ACC/AHA Task Force on Practice Guidelines summary of recommendations. J Vasc Interv Radiol 2006;17:1383–1397.

  2. Norgren L, Hiatt WR, Dormandy JA, et al. For the TASC II Working Group. Inter-society consensus for the management of peripheral arterial disease (TASC II). J Vasc Surg. 2007;45(Suppl S):S5–67.

    Article  PubMed  Google Scholar 

  3. Dick P, Sabeti S, Mlekusch W, et al. Conventional balloon angioplasty versus peripheral cutting balloon angioplasty for treatment of femoropopliteal artery in-stent restenosis: initial experience. Radiology. 2008;248:297–302.

    Article  PubMed  Google Scholar 

  4. Rocha-Singh KJ, Jaff MR, Crabtree TR, Bloch DA, Ansel G. Performance goals and endpoint assessments for clinical trials of femoropopliteal bare nitinol stents in patients with symptomatic peripheral arterial disease. Catheter Cardiovasc Interv. 2007;69:910–9.

    Article  PubMed  Google Scholar 

  5. Schillinger M, Sabeti S, Loewe C, et al. Balloon angioplasty versus implantation of nitinol stents in the superficial femoral artery. N Engl J Med. 2006;354:1879–88.

    Article  CAS  PubMed  Google Scholar 

  6. Scheinert D, Scheinert S, Sax J, et al. Prevalence and clinical impact of stent fractures after femoropopliteal stenting. J Am Coll Cardiol. 2005;45:312–5.

    Article  PubMed  Google Scholar 

  7. Krankenberg H, Schlüter M, Steinkamp HJ, et al. Nitinol stent implantation versus percutaneous transluminal angioplasty in superficial femoral artery lesions up to 10 cm in length: the Femoral Artery Stenting Trial (FAST). Circulation. 2007;116:285–92.

    Article  CAS  PubMed  Google Scholar 

  8. Iida O, Nanto S, Uematsu M, Ikeoka K, Okamoto S, Nagata S. Influence of stent fracture on the long-term patency in the femoro-popliteal artery: experience of 4 years. JACC Cardiovasc Interv. 2009;2:665–71.

    Article  PubMed  Google Scholar 

  9. Schlager O, Dick P, Sabeti S, et al. Long-segment SFA stenting—the dark sides: in-stent restenosis, clinical deterioration, and stent fractures. J Endovasc Ther. 2005;12:676–84.

    Article  PubMed  Google Scholar 

  10. Wohlre J. Drug-coated balloons for coronary and peripheral intervention procedures. Curr Cardiol Rep. 2012;14:635–41.

    Article  Google Scholar 

  11. Granada JF, Milewski K, Zhao H, et al. Vascular response to zotarolimus-coated balloons in injured superficial femoral arteries of the familial hypercholesterolemic swine. Circ Cardiovasc Interv. 2011;4:447–55.

    Article  CAS  PubMed  Google Scholar 

  12. Schmehl J, von der Ruhr J, Dobratz M, et al. Balloon coating with rapamycin using an on-site coating device. Cardiovasc Intervent Radiol. 2013;36:756–63.

    Article  PubMed  Google Scholar 

  13. Ong PJ, Kubo T, Watson TJ, Seah AS, Wong PE, Akasaka T. Angiographic, optical coherence tomography and histology findings from combination of a drug-coated balloon with an everolimus-eluting stent in a porcine model. Int J Cardiol. 2016 Aug 18;223:665–8.

    Article  PubMed  Google Scholar 

  14. Tepe G, Zeller T, Albrecht T, et al. Local delivery of paclitaxel to inhibit restenosis during angioplasty of the leg. N Engl J Med. 2008;358(7):689–99.

    Article  CAS  PubMed  Google Scholar 

  15. •• Tepe G, Schnorr B, Albrecht T, et al. Angioplasty of femoral-popliteal arteries with drug-coated balloons: 5-year follow-up of the THUNDER Trial. JACC Cardiovasc Interv. 2015;8(1PartA):102–8. This study is important as it provides longer–term outcome of DCB

    Article  PubMed  Google Scholar 

  16. Werk M, Langner S, Reinkensmeier B, et al. Inhibition of restenosis in femoropopliteal arteries: Paclitaxel-coated versus uncoated balloon: femoral paclitaxel randomized pilot trial. Circulation. 2008;118:1358.

    Article  CAS  PubMed  Google Scholar 

  17. Werk M, Albrecht T, Meyer DR, et al. Paclitaxel-coated balloons reduce restenosis after femoro-popliteal angioplasty: evidence from the randomized PACIFIER trial. Circ Cardiovasc Interv. 2012;5:831.

    Article  CAS  PubMed  Google Scholar 

  18. • Scheinert D, Duda S, Zeller T, et al. The LEVANT I (Lutonix paclitaxel coated balloon for the prevention of femoropopliteal restenosis) trial for femoropopliteal revascularization: first-in-human randomized trial of low-dose drug-coated balloon versus uncoated balloon angioplasty. JACC Cardiovasc Interv. 2014;7(1):10–9. This is an important study as it is the first study for another type of DCB

    Article  PubMed  Google Scholar 

  19. •• Rosenfield K, Jaff MR, White CJ, et al. LEVANT 2 investigators. Trial of a paclitaxel-coated balloon for femoropopliteal artery disease. N Engl J Med. 2015;373(2):145–53. One of the major trials in the field of DCB

    Article  CAS  PubMed  Google Scholar 

  20. •• Tepe G, Laird J, Schneider P, et al. IN.PACT SFA Trial Investigators. Drug-coated balloon versus standard percutaneous transluminal angioplasty for the treatment of superficial femoral and/or popliteal peripheral artery disease: 12-month results from the IN.PACT SFA Randomized Trial. Circulation. 2015;131(5):495–502. One of the major trials in the field of DCB

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  21. •• Schroeder H, Meyer DR, Lux B, Ruecker F, Martorana M, Duda S. Two-year results of a low-dose drug-coated balloon for revascularization of the femoropopliteal artery: outcomes from the ILLUMENATE first-in-human study. Catheter Cardiovasc Interv. 2015;86(2):278–86. This study highlights a new DCB with a lower paclitaxel doses

    Article  PubMed  Google Scholar 

  22. Lyden S, Krishnan P and ILLUMENATE Pivotal investigators. ILLUMENATE Pivotal Stellarex DCB IDE Study 12-month results. TCT 2016.

  23. Clinical Trials, a service of the U.S. National Institute of Health. https://clinicaltrials.gov

  24. Schmidt A, Piorkowski M, Werner M, et al. First experience with drug-eluting balloons in infrapopliteal arteries: restenosis rate and clinical outcome. J Am Coll Cardiol. 2011;58(11):1105–9.

    Article  CAS  PubMed  Google Scholar 

  25. Schmidt A, Ulrich M, Winkler B, et al. Angiographic patency and clinical outcome after balloon-angioplasty for extensive infrapopliteal arterial disease. Catheter Cardiovasc Interv. 2010;76:1047–54.

    Article  PubMed  Google Scholar 

  26. Fanelli F, Cannavale A, Boatta E, et al. Lower limb multilevel treatment with drug-eluting balloons: 6-month results from the DEBELLUM randomized trial. J Endovasc Ther. 2012;19:571.

    Article  PubMed  Google Scholar 

  27. Liistro F, Porto I, Angioli P, et al. 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(6):615–21.

    Article  CAS  PubMed  Google Scholar 

  28. •• Zeller T, Baumgartner I, Scheinert D, et al. IN.PACT DEEP Trial Investigators. Drug-eluting balloon versus standard balloon angioplasty for infrapopliteal arterial revascularization in critical limb ischemia: 12-month results from the IN.PACT DEEP randomized trial. J Am Coll Cardiol. 2014;64(15):1568–76. This study is important as it raises concern about the safety of using in infrapopliteal disease

    Article  PubMed  Google Scholar 

  29. • Zeller T, Beschorner U, Pilger E, et al. Paclitaxel-coated balloon in infrapopliteal arteries: 12-month results from the BIOLUX P-II randomized trial (BIOTRONIK’S-first in man study of the Passeo-18 LUX drug releasing PTA balloon catheter vs. the uncoated Passeo-18 PTA balloon catheter in subjects requiring revascularization of infrapopliteal arteries). JACC Cardiovasc Interv. 2015;8(12):1614–22. This is study is important as it covers a new type of DCB

    Article  PubMed  Google Scholar 

  30. •• Liistro F, Angioli P, Porto I, et al. Paclitaxel-eluting balloon vs. standard angioplasty to reduce recurrent restenosis in diabetic patients with in-stent restenosis of the superficial femoral and proximal popliteal arteries: the DEBATE-ISR study. J Endovasc Ther. 2014;21(1):1–8. One of the main studies highlighting the use of DCB in ISR

    Article  PubMed  Google Scholar 

  31. •• Krankenberg H, Tubler T, Ingwersen M, et al. Drug-coated balloon versus standard balloon for superficial femoral artery in-stent restenosis: the randomized femoral artery in-stent restenosis (FAIR) trial. Circulation. 2015;132(23):2230–6. One of the main studies highlighting the use of DCB in ISR

    Article  CAS  PubMed  Google Scholar 

  32. Olin J, White C, Armstrong E, Kadian-Dodov D, Hiatt W. Peripheral artery disease. Evolving role of exercise, medical therapy, and endovascular options. JACC. 2016;67(11):1338–57.

    Article  PubMed  Google Scholar 

  33. Gerhard-Herman M, et al. 2016 AHA/ACC guideline on the management of patients with lower extremity peripheral artery disease: executive summary: a report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. Circulation. 2017 Mar 21;135(12):e686–725.

    Article  PubMed  Google Scholar 

Download references

Author information

Authors and Affiliations

  1. Department of Medicine, Division of Cardiology, Massachusetts General Hospital, Boston, MA, USA

    Rasha F. Al-Bawardy & Kenneth Rosenfield

  2. Department of Medicine, Division of Cardiology, VA Eastern Colorado Healthcare System, Denver, CO, USA

    Stephen W. Waldo

Authors
  1. Rasha F. Al-Bawardy
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Stephen W. Waldo
    View author publications

    You can also search for this author in PubMed Google Scholar

  3. Kenneth Rosenfield
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to Kenneth Rosenfield.

Ethics declarations

Conflict of Interest

Rasha F. Al-Bawardy declares that he has no conflict of interest.

Kenneth Rosenfield reports following disclosures: Consultant/Scientific Advisory Board for Abbott Vascular, Cardinal Health, Inari Medical, Inspire MD, Surmodics, Volcano/Philips, Proteon. Consultant/Scientific Advisory Board with Equity or Stock Options for Capture Vascular, Contego, CRUZAR Systems, Endospan, Eximo, MD Insider, Micell, Shockwave, Silk Road Medical, Valcare. Research or Fellowship Support from Abbott Vascular, Atrium, NIH and Lutonix-Bard. Personal Equity: Access Vascular, Cardio MEMs, Contego, CRUZAR Systems, Embolitech, Icon, Janacare, MD Insider, Primacea, PQ Bypass and Vortex. Board Member of VIVA Physicians.

Stephen W. Waldo has received investigator-initiated research grants to the Denver Research Institute from Abiomed, Cardiovascular Systems Incorporated, and Merck Pharmaceuticals.

Human and Animal Rights and Informed Consent

This article does not contain any studies with human or animal subjects performed by any of the authors.

Additional information

This article is part of the Topical Collection on Peripheral Vascular Disease

Rights and permissions

Reprints and permissions

About this article

Check for updates. Verify currency and authenticity via CrossMark

Cite this article

Al-Bawardy, R.F., Waldo, S.W. & Rosenfield, K. Advances in Percutaneous Therapies for Peripheral Artery Disease: Drug-Coated Balloons. Curr Cardiol Rep 19, 99 (2017). https://doi.org/10.1007/s11886-017-0913-3

Download citation

  • Published:

  • DOI: https://doi.org/10.1007/s11886-017-0913-3

Keywords

Search

Navigation