Skip to main content

Advertisement

Log in

Paclitaxel-Coated Balloon for Femoropopliteal Artery Disease

  • Ischemic Heart Disease (D Mukherjee, Section Editor)
  • Published:
Current Cardiology Reports Aims and scope Submit manuscript

Abstract

Purpose of the Review

Percutaneous transluminal angioplasty is an established form of therapy for femoropopliteal artery disease. Currently, percutaneous transluminal angioplasty (PTA) is carried out using standard balloon with or without deployment of a stent but is associated with a high rate of restenosis and stent-related complications. Treatment options for restenosis, especially in-stent restenosis, are limited. Drug-coated balloons promise to reduce the rates of restenosis by effective delivery of antiproliferative agent (paclitaxel) directly to vessel wall without the need for a permanent implant. In this review, we look at the technology and rationale behind drug-coated balloons and examine the evidence available so far.

Recent Findings

Recently, several studies tested the effectiveness of paclitaxel-coated balloon angioplasty compared to that of standard PTA in both de novo lesions and in-stent restenosis of femoropopliteal artery. Paclitaxel-coated balloon use resulted in reduced rates of restenosis and favourable clinical outcomes in both these lesion groups. However, in complex lesions, there is still lack of data to support the use of these balloons.

Summary

Paclitaxel-coated balloon is a safe and effective therapeutic option in patients with both de novo lesions and in-stent restenosis involving femoropopliteal artery. In light of the new evidence, it is time to consider incorporation of this effective therapeutic option into clinical practice. However, further research is needed for the use of paclitaxel-coated balloons in complex femoropopliteal lesions like calcified lesions especially as adjuncts to cutting balloons and debulking strategies.

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.

Similar content being viewed by others

References

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

  1. Fowkes FG, Rudan D, Rudan I, Aboyans V, Denenberg JO, McDermott MM, et al. Comparison of global estimates of prevalence and risk factors for peripheral artery disease in 2000 and 2010: a systematic review and analysis. Lancet. 2013;382(9901):1329–40. doi:10.1016/S0140-6736(13)61249-0.

    Article  PubMed  Google Scholar 

  2. Norgren L, Hiatt WR, Dormandy JA, Nehler MR, Harris KA, Fowkes FG, et al. Inter-Society Consensus for the Management of Peripheral Arterial Disease (TASC II). J Vasc Surg. 2007;(45 Suppl S):S5–67. doi:10.1016/j.jvs.2006.12.037.

  3. Rooke TW, Hirsch AT, Misra S, Sidawy AN, Beckman JA, Findeiss LK, et al. 2011 ACCF/AHA focused update of the guideline for the management of patients with peripheral artery disease (updating the 2005 guideline): a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol. 2011;58(19):2020–45. doi:10.1016/j.jacc.2011.08.023.

    Article  PubMed  Google Scholar 

  4. Schillinger M, Minar E. Percutaneous treatment of peripheral artery disease: novel techniques. Circulation. 2012;126(20):2433–40. doi:10.1161/CIRCULATIONAHA.111.036574.

    Article  PubMed  Google Scholar 

  5. Rocha-Singh KJ, Jaff MR, Crabtree TR, Bloch DA, Ansel G, Viva PI. Performance goals and endpoint assessments for clinical trials of femoropopliteal bare nitinol stents in patients with symptomatic peripheral arterial disease. Catheterization and Cardiovascular Interventions: Official Journal of the Society for Cardiac Angiography & Interventions. 2007;69(6):910–9. doi:10.1002/ccd.21104.

    Article  Google Scholar 

  6. Schillinger M, Sabeti S, Loewe C, Dick P, Amighi J, Mlekusch W, et al. Balloon angioplasty versus implantation of nitinol stents in the superficial femoral artery. N Engl J Med. 2006;354(18):1879–88. doi:10.1056/NEJMoa051303.

    Article  CAS  PubMed  Google Scholar 

  7. Laird JR, Katzen BT, Scheinert D, Lammer J, Carpenter J, Buchbinder M, et al. Nitinol stent implantation versus balloon angioplasty for lesions in the superficial femoral artery and proximal popliteal artery: twelve-month results from the RESILIENT randomized trial. Circulation Cardiovascular Interventions. 2010;3(3):267–76. doi:10.1161/CIRCINTERVENTIONS.109.903468.

    Article  PubMed  Google Scholar 

  8. Soga Y, Iida O, Hirano K, Yokoi H, Nanto S, Nobuyoshi M. Mid-term clinical outcome and predictors of vessel patency after femoropopliteal stenting with self-expandable nitinol stent. J Vasc Surg. 2010;52(3):608–15. doi:10.1016/j.jvs.2010.03.050.

    Article  PubMed  Google Scholar 

  9. Scheinert D, Grummt L, Piorkowski M, Sax J, Scheinert S, Ulrich M, et al. A novel self-expanding interwoven nitinol stent for complex femoropopliteal lesions: 24-month results of the SUPERA SFA registry. J Endovasc Ther. 2011;18(6):745–52. doi:10.1583/11-3500.1.

    Article  PubMed  Google Scholar 

  10. Bosiers M, Torsello G, Gissler HM, Ruef J, Muller-Hulsbeck S, Jahnke T, et al. Nitinol stent implantation in long superficial femoral artery lesions: 12-month results of the DURABILITY I study. J Endovasc Ther. 2009;16(3):261–9. doi:10.1583/08-2676.1.

    Article  PubMed  Google Scholar 

  11. Matsumura JS, Yamanouchi D, Goldstein JA, Pollock CW, Bosiers M, Schultz GA, et al. The United States StuDy for EvalUating EndovasculaR TreAtments of lesions in the superficial femoral artery and proximal popliteal by usIng the Protege EverfLex NitInol STent SYstem II (DURABILITY II). J Vasc Surg. 2013;58(1):73–83 e1. doi:10.1016/j.jvs.2012.12.066.

    Article  PubMed  Google Scholar 

  12. Schillinger M, Sabeti S, Dick P, Amighi J, Mlekusch W, Schlager O, et al. Sustained benefit at 2 years of primary femoropopliteal stenting compared with balloon angioplasty with optional stenting. Circulation. 2007;115(21):2745–9. doi:10.1161/CIRCULATIONAHA.107.688341.

    Article  PubMed  Google Scholar 

  13. Laird JR, Katzen BT, Scheinert D, Lammer J, Carpenter J, Buchbinder M, et al. Nitinol stent implantation vs. balloon angioplasty for lesions in the superficial femoral and proximal popliteal arteries of patients with claudication: three-year follow-up from the RESILIENT randomized trial. J Endovasc Ther. 2012;19(1):1–9. doi:10.1583/11-3627.1.

    Article  PubMed  Google Scholar 

  14. Duda SH, Pusich B, Richter G, Landwehr P, Oliva VL, Tielbeek A, et al. Sirolimus-eluting stents for the treatment of obstructive superficial femoral artery disease: six-month results. Circulation. 2002;106(12):1505–9.

    Article  CAS  PubMed  Google Scholar 

  15. Duda SH, Bosiers M, Lammer J, Scheinert D, Zeller T, Tielbeek A, et al. Sirolimus-eluting versus bare nitinol stent for obstructive superficial femoral artery disease: the SIROCCO II trial. Journal of Vascular and Interventional Radiology: JVIR. 2005;16(3):331–8. doi:10.1097/01.RVI.0000151260.74519.CA.

    Article  PubMed  Google Scholar 

  16. Duda SH, Bosiers M, Lammer J, Scheinert D, Zeller T, Oliva V, et al. Drug-eluting and bare nitinol stents for the treatment of atherosclerotic lesions in the superficial femoral artery: long-term results from the SIROCCO trial. J Endovasc Ther. 2006;13(6):701–10. doi:10.1583/05-1704.1.

    Article  PubMed  Google Scholar 

  17. Dake MD, Ansel GM, Jaff MR, Ohki T, Saxon RR, Smouse HB, et al. Paclitaxel-eluting stents show superiority to balloon angioplasty and bare metal stents in femoropopliteal disease: twelve-month Zilver PTX randomized study results. Circulation Cardiovascular Interventions. 2011;4(5):495–504. doi:10.1161/CIRCINTERVENTIONS.111.962324.

    Article  CAS  PubMed  Google Scholar 

  18. Dake MD, Scheinert D, Tepe G, Tessarek J, Fanelli F, Bosiers M, et al. Nitinol stents with polymer-free paclitaxel coating for lesions in the superficial femoral and popliteal arteries above the knee: twelve-month safety and effectiveness results from the Zilver PTX single-arm clinical study. J Endovasc Ther. 2011;18(5):613–23. doi:10.1583/11-3560.1.

    Article  PubMed  Google Scholar 

  19. Dake MD, Ansel GM, Jaff MR, Ohki T, Saxon RR, Smouse HB, et al. Sustained safety and effectiveness of paclitaxel-eluting stents for femoropopliteal lesions: 2-year follow-up from the Zilver PTX randomized and single-arm clinical studies. J Am Coll Cardiol. 2013;61(24):2417–27. doi:10.1016/j.jacc.2013.03.034.

    Article  CAS  PubMed  Google Scholar 

  20. Scheinert D, Scheinert S, Sax J, Piorkowski C, Braunlich S, Ulrich M, et al. Prevalence and clinical impact of stent fractures after femoropopliteal stenting. J Am Coll Cardiol. 2005;45(2):312–5. doi:10.1016/j.jacc.2004.11.026.

    Article  PubMed  Google Scholar 

  21. Krankenberg H, Schluter M, Steinkamp HJ, Burgelin K, Scheinert D, Schulte KL, 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(3):285–92. doi:10.1161/CIRCULATIONAHA.107.689141.

    Article  CAS  PubMed  Google Scholar 

  22. 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 Cardiovascular Interventions. 2009;2(7):665–71. doi:10.1016/j.jcin.2009.04.014.

    Article  PubMed  Google Scholar 

  23. Schlager O, Dick P, Sabeti S, Amighi J, Mlekusch W, Minar E, et al. Long-segment SFA stenting—the dark sides: in-stent restenosis, clinical deterioration, and stent fractures. J Endovasc Ther. 2005;12(6):676–84. doi:10.1583/05-1672.1.

    Article  PubMed  Google Scholar 

  24. Radke PW, Joner M, Joost A, Byrne RA, Hartwig S, Bayer G, et al. Vascular effects of paclitaxel following drug-eluting balloon angioplasty in a porcine coronary model: the importance of excipients. EuroIntervention: Journal of EuroPCR in Collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology. 2011;7(6):730–7. doi:10.4244/EIJV7I6A116.

    Article  Google Scholar 

  25. Milewski K, Tellez A, Aboodi MS, Conditt GB, Yi GH, Thim T, et al. Paclitaxel-iopromide coated balloon followed by “bail-out” bare metal stent in porcine iliofemoral arteries: first report on biological effects in peripheral circulation. EuroIntervention: Journal of EuroPCR in Collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology. 2011;7(3):362–8. doi:10.4244/EIJV7I3A61.

    Article  Google Scholar 

  26. Yazdani SK, Pacheco E, Nakano M, Otsuka F, Naisbitt S, Kolodgie FD, et al. Vascular, downstream, and pharmacokinetic responses to treatment with a low dose drug-coated balloon in a swine femoral artery model. Catheterization and Cardiovascular Interventions: Official Journal of the Society for Cardiac Angiography & Interventions. 2014;83(1):132–40. doi:10.1002/ccd.24995.

    Article  Google Scholar 

  27. Hwang C-W, Wu D, Edelman ER. Physiological transport forces govern drug distribution for stent-based delivery. Circulation. 2001;104(5):600–5. doi:10.1161/hc3101.092214.

    Article  CAS  PubMed  Google Scholar 

  28. Moses JW, Leon MB, Popma JJ, Fitzgerald PJ, Holmes DR, O’Shaughnessy C, et al. Sirolimus-eluting stents versus standard stents in patients with stenosis in a native coronary artery. N Engl J Med. 2003;349(14):1315–23. doi:10.1056/NEJMoa035071.

    Article  CAS  PubMed  Google Scholar 

  29. Iofina E, Langenberg R, Blindt R, Kühl H, Kelm M, Hoffmann R. Polymer-based paclitaxel-eluting stents are superior to nonpolymer-based paclitaxel-eluting stents in the treatment of de novo coronary lesions. Am J Cardiol. 98(8):1022–7. doi:10.1016/j.amjcard.2006.05.019.

  30. Joner M, Finn AV, Farb A, Mont EK, Kolodgie FD, Ladich E, et al. Pathology of drug-eluting stents in humans: delayed healing and late thrombotic risk. J Am Coll Cardiol. 2006;48(1):193–202. doi:10.1016/j.jacc.2006.03.042.

    Article  PubMed  Google Scholar 

  31. van der Giessen WJ, Lincoff AM, Schwartz RS, van Beusekom HMM, Serruys PW, Holmes DR, et al. Marked inflammatory sequelae to implantation of biodegradable and nonbiodegradable polymers in porcine coronary arteries. Circulation. 1996;94(7):1690–7. doi:10.1161/01.cir.94.7.1690.

    Article  PubMed  Google Scholar 

  32. Virmani R, Guagliumi G, Farb A, Musumeci G, Grieco N, Motta T et al. Localized hypersensitivity and late coronary thrombosis secondary to a Sirolimus-eluting stent. Should we be cautious? 2004;109(6):701–5. doi:10.1161/01.cir.0000116202.41966.d4.

  33. Tian W, Kuhlmann MT, Pelisek J, Scobioala S, Quang TH, Hasib L, et al. Paclitaxel delivered to adventitia attenuates neointima formation without compromising re-endothelialization after angioplasty in a porcine restenosis model. J Endovasc Ther. 2006;13(5):616–29. doi:10.1583/05-1802MR.1.

    Article  PubMed  Google Scholar 

  34. Speck U, Scheller B, Abramjuk C, Grossmann S, Mahnkopf D, Simon O. Inhibition of restenosis in stented porcine coronary arteries: uptake of paclitaxel from angiographic contrast media. Investig Radiol. 2004;39(3):182–6.

    Article  CAS  Google Scholar 

  35. Oberhoff M, Kunert W, Herdeg C, Kuttner A, Kranzhofer A, Horch B, et al. Inhibition of smooth muscle cell proliferation after local drug delivery of the antimitotic drug paclitaxel using a porous balloon catheter. Basic Res Cardiol. 2001;96(3):275–82.

    Article  CAS  PubMed  Google Scholar 

  36. Herdeg C, Oberhoff M, Baumbach A, Blattner A, Axel DI, Schroder S, et al. Local paclitaxel delivery for the prevention of restenosis: biological effects and efficacy in vivo. J Am Coll Cardiol. 2000;35(7):1969–76.

    Article  CAS  PubMed  Google Scholar 

  37. Margolis J, McDonald J, Heuser R, Klinke P, Waksman R, Virmani R, et al. Systemic nanoparticle paclitaxel (nab-paclitaxel) for in-stent restenosis I (SNAPIST-I): a first-in-human safety and dose-finding study. Clin Cardiol. 2007;30(4):165–70. doi:10.1002/clc.20066.

    Article  PubMed  Google Scholar 

  38. Axel DI, Kunert W, Göggelmann C, Oberhoff M, Herdeg C, Küttner A, 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. doi:10.1161/01.cir.96.2.636.

    Article  CAS  PubMed  Google Scholar 

  39. 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. doi:10.1007/s00280-006-0209-6.

    Article  CAS  PubMed  Google Scholar 

  40. Schnorr B, Speck U, Scheller B. Review of clinical data with Paccocath-coated balloon catheters. Minerva Cardioangiol. 2011;59(5):431–45.

    CAS  PubMed  Google Scholar 

  41. • Scheinert D, Duda S, Zeller T, Krankenberg H, Ricke J, Bosiers M, 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 Cardiovascular Interventions. 2014;7(1):10–9. doi:10.1016/j.jcin.2013.05.022. This trial employed a drug-coated balloon with lower dose of paclitaxel using a novel formulation

    Article  PubMed  Google Scholar 

  42. Tharp DL, Wamhoff BR, Wulff H, Raman G, Cheong A, Bowles DK. Local delivery of the KCa3.1 blocker, TRAM-34, prevents acute angioplasty-induced coronary smooth muscle phenotypic modulation and limits stenosis. Arterioscler Thromb Vasc Biol. 2008;28(6):1084–9. doi:10.1161/ATVBAHA.107.155796.

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  43. Sheiban I, Anselmino M, Moretti C, Biondi-Zoccai G, Galloni M, Vignolini C, et al. Effect of a novel drug-eluted balloon coated with genistein before stent implantation in porcine coronary arteries. Clinical Research in Cardiology: Official Journal of the German Cardiac Society. 2008;97(12):891–8. doi:10.1007/s00392-008-0705-2.

    Article  CAS  Google Scholar 

  44. •• Tepe G, Zeller T, Albrecht T, Heller S, Schwarzwalder U, Beregi JP, et al. Local delivery of paclitaxel to inhibit restenosis during angioplasty of the leg. N Engl J Med. 2008;358(7):689–99. doi:10.1056/NEJMoa0706356. The first randomized clinical trial that studied drug-coated balloons in peripheral arterial disease

    Article  CAS  PubMed  Google Scholar 

  45. Werk M, Langner S, Reinkensmeier B, Boettcher HF, Tepe G, Dietz U, et al. Inhibition of restenosis in femoropopliteal arteries: paclitaxel-coated versus uncoated balloon: femoral paclitaxel randomized pilot trial. Circulation. 2008;118(13):1358–65. doi:10.1161/CIRCULATIONAHA.107.735985.

    Article  CAS  PubMed  Google Scholar 

  46. Tepe G, Schnorr B, Albrecht T, Brechtel K, Claussen CD, Scheller B, et al. Angioplasty of femoral-popliteal arteries with drug-coated balloons: 5-year follow-up of the THUNDER trial. JACC Cardiovascular Interventions. 2015;8(1 Pt A):102–8. doi:10.1016/j.jcin.2014.07.023.

    Article  PubMed  Google Scholar 

  47. Micari A, Cioppa A, Vadala G, Castriota F, Liso A, Marchese A, et al. Clinical evaluation of a paclitaxel-eluting balloon for treatment of femoropopliteal arterial disease: 12-month results from a multicenter Italian registry. JACC Cardiovascular Interventions. 2012;5(3):331–8. doi:10.1016/j.jcin.2011.11.010.

    Article  PubMed  Google Scholar 

  48. Werk M, Albrecht T, Meyer DR, Ahmed MN, Behne A, Dietz U, et al. Paclitaxel-coated balloons reduce restenosis after femoro-popliteal angioplasty: evidence from the randomized PACIFIER trial. Circulation Cardiovascular Interventions. 2012;5(6):831–40. doi:10.1161/CIRCINTERVENTIONS.112.971630.

    Article  CAS  PubMed  Google Scholar 

  49. Rosenfield K, Jaff MR, White CJ, Rocha-Singh K, Mena-Hurtado C, Metzger DC, et al. Trial of a paclitaxel-coated balloon for femoropopliteal artery disease. N Engl J Med. 2015;373(2):145–53. doi:10.1056/NEJMoa1406235.

    Article  CAS  PubMed  Google Scholar 

  50. Tepe G, Laird J, Schneider P, Brodmann M, Krishnan P, Micari A, et al. 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(5):495–502. doi:10.1161/CIRCULATIONAHA.114.011004.

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  51. Scheinert D, Karl-Ludwig S, Thomas Z, Schmidt A, Langhoff R, Rastan A, et al. TCT-585 six month results of the BIOLUX P-I first in man study comparing a paclitaxel releasing balloon catheter versus an uncoated balloon catheter in femoropopliteal lesions. J Am Coll Cardiol. 2012;60(17_S) doi:10.1016/j.jacc.2012.08.621.

  52. Zeller T, Rastan A, Sixt S, Schwarzwalder U, Schwarz T, Frank U, et al. Long-term results after directional atherectomy of femoro-popliteal lesions. J Am Coll Cardiol. 2006;48(8):1573–8. doi:10.1016/j.jacc.2006.07.031.

    Article  PubMed  Google Scholar 

  53. Yeo KK, Malik U, Laird JR. Outcomes following treatment of femoropopliteal in-stent restenosis: a single center experience. Catheterization and Cardiovascular Interventions: Official journal of the Society for Cardiac Angiography & Interventions. 2011;78(4):604–8. doi:10.1002/ccd.23022.

    Article  Google Scholar 

  54. Dick P, Sabeti S, Mlekusch W, Schlager O, Amighi J, Haumer M, et al. Conventional balloon angioplasty versus peripheral cutting balloon angioplasty for treatment of femoropopliteal artery in-stent restenosis: initial experience. Radiology. 2008;248(1):297–302. doi:10.1148/radiol.2481071159.

    Article  PubMed  Google Scholar 

  55. Tosaka A, Soga Y, Iida O, Ishihara T, Hirano K, Suzuki K, et al. Classification and clinical impact of restenosis after femoropopliteal stenting. J Am Coll Cardiol. 2012;59(1):16–23. doi:10.1016/j.jacc.2011.09.036.

    Article  PubMed  Google Scholar 

  56. Scheller B, Hehrlein C, Bocksch W, Rutsch W, Haghi D, Dietz U, et al. Treatment of coronary in-stent restenosis with a paclitaxel-coated balloon catheter. N Engl J Med. 2006;355(20):2113–24. doi:10.1056/NEJMoa061254.

    Article  CAS  PubMed  Google Scholar 

  57. Virga V, Stabile E, Biamino G, Salemme L, Cioppa A, Giugliano G, et al. Drug-eluting balloons for the treatment of the superficial femoral artery in-stent restenosis: 2-year follow-up. JACC Cardiovascular Interventions. 2014;7(4):411–5. doi:10.1016/j.jcin.2013.11.020.

    Article  PubMed  Google Scholar 

  58. Stabile E, Virga V, Salemme L, Cioppa A, Ambrosini V, Sorropago G, et al. Drug-eluting balloon for treatment of superficial femoral artery in-stent restenosis. J Am Coll Cardiol. 2012;60(18):1739–42. doi:10.1016/j.jacc.2012.07.033.

    Article  CAS  PubMed  Google Scholar 

  59. Krankenberg H, Tubler T, Ingwersen M, Schluter M, Scheinert D, Blessing E, 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. doi:10.1161/CIRCULATIONAHA.115.017364.

    Article  CAS  PubMed  Google Scholar 

  60. Liistro F, Angioli P, Porto I, Ricci L, Ducci K, Grotti S, 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. doi:10.1583/13-4420R.1.

    Article  PubMed  Google Scholar 

  61. Grotti S, Liistro F, Angioli P, Ducci K, Falsini G, Porto I, et al. Paclitaxel-eluting balloon vs standard angioplasty to reduce restenosis in diabetic patients with In-stent restenosis of the superficial femoral and proximal popliteal arteries: three-year results of the DEBATE-ISR study. J Endovasc Ther. 2016;23(1):52–7. doi:10.1177/1526602815614555.

    Article  PubMed  Google Scholar 

  62. Kinstner CM, Lammer J, Willfort-Ehringer A, Matzek W, Gschwandtner M, Javor D, et al. Paclitaxel-eluting balloon versus standard balloon angioplasty in in-stent restenosis of the superficial femoral and proximal popliteal artery 1-year results of the PACUBA trial. J Am Coll Cardiol Intv. 2016;9(13):1386–92. doi:10.1016/j.jcin.2016.04.012.

    Article  Google Scholar 

  63. Liistro F, Grotti S, Porto I, Angioli P, Ricci L, Ducci K, et al. Drug-eluting balloon in peripheral intervention for the superficial femoral artery: the DEBATE-SFA randomized trial (drug eluting balloon in peripheral intervention for the superficial femoral artery). JACC Cardiovascular Interventions. 2013;6(12):1295–302. doi:10.1016/j.jcin.2013.07.010.

    Article  PubMed  Google Scholar 

  64. European Stroke O, Tendera M, Aboyans V, Bartelink ML, Baumgartner I, Clement D, et al. ESC guidelines on the diagnosis and treatment of peripheral artery diseases: document covering atherosclerotic disease of extracranial carotid and vertebral, mesenteric, renal, upper and lower extremity arteries: the Task Force on the Diagnosis and Treatment of Peripheral Artery Diseases of the European Society of Cardiology (ESC). Eur Heart J. 2011;32(22):2851–906. doi:10.1093/eurheartj/ehr211.

    Article  Google Scholar 

  65. Rooke TW, Hirsch AT, Misra S, Sidawy AN, Beckman JA, Findeiss L, et al. Management of patients with peripheral artery disease (compilation of 2005 and 2011 ACCF/AHA guideline recommendations): a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol. 2013;61(14):1555–70. doi:10.1016/j.jacc.2013.01.004.

    Article  PubMed  Google Scholar 

  66. Hirsch AT, Haskal ZJ, Hertzer NR, Bakal CW, Creager MA, Halperin JL, et al. ACC/AHA 2005 guidelines for the management of patients with peripheral arterial disease (lower extremity, renal, mesenteric, and abdominal aortic): executive summary a collaborative report from the American Association for Vascular Surgery/Society for Vascular Surgery, Society for Cardiovascular Angiography and Interventions, Society for Vascular Medicine and Biology, Society of Interventional Radiology, and the ACC/AHA Task Force on Practice Guidelines (Writing Committee to Develop Guidelines for the Management of Patients with Peripheral Arterial Disease) endorsed by the American Association of Cardiovascular and Pulmonary Rehabilitation; National Heart, Lung, and Blood Institute; Society for Vascular Nursing; TransAtlantic Inter-Society Consensus; and Vascular Disease Foundation. J Am Coll Cardiol. 2006;47(6):1239–312. doi:10.1016/j.jacc.2005.10.009.

    Article  PubMed  Google Scholar 

  67. • Teleb M, Wardi M, Gosavi S, Said S, Mukherjee D. Paclitaxel-coated balloons: review of a promising interventional approach to preventing restenosis in femoropopliteal arteries. Int J Angiol. 2016;25(2):75–80. doi:10.1055/s-0035-1563608. This is a recent review article on use of paclitaxel-coated balloons in femoropopliteal disease

    PubMed  Google Scholar 

Download references

Author information

Authors and Affiliations

Authors

Corresponding author

Correspondence to Saurabh Mehrotra.

Ethics declarations

Conflict of Interest

Saurabh Mehrotra, Ganesh Paramasivam, and Sundeep Mishra declare that they have no conflict of interest.

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 Ischemic Heart Disease

Rights and permissions

Reprints and permissions

About this article

Check for updates. Verify currency and authenticity via CrossMark

Cite this article

Mehrotra, S., Paramasivam, G. & Mishra, S. Paclitaxel-Coated Balloon for Femoropopliteal Artery Disease. Curr Cardiol Rep 19, 10 (2017). https://doi.org/10.1007/s11886-017-0823-4

Download citation

  • Published:

  • DOI: https://doi.org/10.1007/s11886-017-0823-4

Keywords

Navigation