Download PDF
Semin intervent Radiol 2023; 40(02): 161-166
DOI: 10.1055/s-0043-57261
Review Article

Drug-Coated Balloon versus Drug-Eluting Stent: The Debate of Leave Nothing Behind

Nicole Keefe
1   Department of Radiology, University of North Carolina School of Medicine, Chapel Hill, North Carolina
,
Trevor Shull
1   Department of Radiology, University of North Carolina School of Medicine, Chapel Hill, North Carolina
,
Lev Botea
2   Department of Vascular Surgery, University of North Carolina School of Medicine, Chapel Hill, North Carolina
,
Katharine McGinigle
2   Department of Vascular Surgery, University of North Carolina School of Medicine, Chapel Hill, North Carolina
› Author Affiliations
› Further Information
Also available at
    Permissions and Reprints

Abstract

Endovascular techniques for peripheral artery disease have changed significantly in the past 10 years with advances in technology and data. Treatment of superficial femoral disease is complex secondary to the length, degree of calcification, high rate of chronic total occlusion, and areas of flexion within this vessel. Use of drug-coated devices has increased the interventionalist's toolbox with the objective to improve freedom from target lesion revascularization and primary patency. There remains debate as to which devices may reach these goals while also limiting overall morbidity and mortality. This article aims to highlight recent advances in the literature regarding the use of drug-coated devices.

Keywords

drug-eluting stent - drug-coated balloon - plain-old balloon angioplasty - bare metal stent - paclitaxel - percutaneous transluminal angioplasty - interventional radiology


Publication History

Article published online:
16 June 2023

© 2023. Thieme. All rights reserved.

Thieme Medical Publishers, Inc.
333 Seventh Avenue, 18th Floor, New York, NY 10001, USA

 

  • References

  • 1 Ansel GM. Drug-coated balloons versus drug-eluting stents in the femoropopliteal artery: comparing apples to oranges?. J Cardiovasc Surg (Torino) 2019; 60 (04) 456-459
    PubMedGoogle Scholar
  • 2 Jones WS, Patel MR, Dai D. et al. High mortality risks after major lower extremity amputation in Medicare patients with peripheral artery disease. Am Heart J 2013; 165 (05) 809-815 , 815.e1
    CrossrefPubMedGoogle Scholar
  • 3 Dua A, Lee CJ. Epidemiology of peripheral arterial disease and critical limb ischemia. Tech Vasc Interv Radiol 2016; 19 (02) 91-95
    CrossrefPubMedGoogle Scholar
  • 4 Lichtenberg MK, Carr JG, Golzar JA. Optical coherence tomography: guided therapy of in-stent restenosis for peripheral arterial disease. J Cardiovasc Surg (Torino) 2017; 58 (04) 518-527
    PubMedGoogle Scholar
  • 5 Dalager S, Paaske WP, Kristensen IB, Laurberg JM, Falk E. Artery-related differences in atherosclerosis expression: implications for atherogenesis and dynamics in intima-media thickness. Stroke 2007; 38 (10) 2698-2705
    CrossrefPubMedGoogle Scholar
  • 6 Bennett MR. In-stent stenosis: pathology and implications for the development of drug eluting stents. Heart 2003; 89 (02) 218-224
    CrossrefPubMedGoogle Scholar
  • 7 Dake MD, Ansel GM, Jaff MR. et al; Zilver PTX Investigators. Durable clinical effectiveness with paclitaxel-eluting stents in the femoropopliteal artery: 5-year results of the Zilver PTX randomized trial. Circulation 2016; 133 (15) 1472-1483 , discussion 1483
    CrossrefPubMedGoogle Scholar
  • 8 Keate BR, Cooper KJ. Anti-restenotic technologies in the SFA: balloons and stents. Tech Vasc Interv Radiol 2022; 25 (03) 100842
    CrossrefPubMedGoogle Scholar
  • 9 Lindquist J, Schramm K. Drug-eluting balloons and drug-eluting stents in the treatment of peripheral vascular disease. Semin Intervent Radiol 2018; 35 (05) 443-452
    Article in Thieme ConnectPubMedGoogle Scholar
  • 10 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 (01) 10-19
    CrossrefPubMedGoogle Scholar
  • 11 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 (02) 145-153
    CrossrefPubMedGoogle Scholar
  • 12 Thieme M, Von Bilderling P, Paetzel C, Karnabatidis D, Perez Delgado J, Lichtenberg M. Lutonix Global SFA Registry Investigators. The 24-month results of the Lutonix global SFA registry: worldwide experience with Lutonix drug-coated balloon. JACC Cardiovasc Interv 2017; 10 (16) 1682-1690
    CrossrefPubMedGoogle Scholar
  • 13 Steiner S, Willfort-Ehringer A, Sievert H. et al; RANGER SFA Investigators. 12-month results from the first-in-human randomized study of the ranger paclitaxel-coated balloon for femoropopliteal treatment. JACC Cardiovasc Interv 2018; 11 (10) 934-941
    CrossrefPubMedGoogle Scholar
  • 14 Lichtenberg M, von Bilderling P, Ranft J. et al. Treatment of femoropopliteal atherosclerotic lesions using the ranger paclitaxel-coated balloon catheter: 12-month results from an all-comers registry. J Cardiovasc Surg (Torino) 2018; 59 (01) 45-50
    PubMedGoogle Scholar
  • 15 Endovascular Today. Accessed April 8, 2023 at: https://evtoday.com/2018/05/09/ranger-sfa-12-month-data-published-for-boston-scientifics-ranger-dcb
    PubMed
  • 16 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 popliteal peripheral artery disease: 12-month results from the IN.PACT SFA randomized trial. Circulation 2015; 131 (05) 495-502
    CrossrefPubMedGoogle Scholar
  • 17 Schneider PA, Laird JR, Tepe G. et al; IN.PACT SFA Trial Investigators. 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 (01) e005891
    CrossrefPubMedGoogle Scholar
  • 18 Laird JA, Schneider PA, Jaff MR. et al. Long-term clinical effectiveness of a drug-coated balloon for the treatment of femoropopliteal lesions: five-year outcomes from the IN.PACT SFA randomized trial. Circ Cardiovasc Interv 2019; 12 (06) e007702
    CrossrefPubMedGoogle Scholar
  • 19 Schroeder H, Werner M, Meyer DR. et al; ILLUMENATE EU RCT Investigators. Low-dose paclitaxel-coated versus uncoated percutaneous transluminal balloon angioplasty for femoropopliteal peripheral artery disease: one-year results of the ILLUMENATE European randomized clinical trial (randomized trial of a novel paclitaxel-coated percutaneous angioplasty balloon). Circulation 2017; 135 (23) 2227-2236
    CrossrefPubMedGoogle Scholar
  • 20 Krishnan P, Faries P, Niazi K. et al. Stellarex drug-coated balloon for treatment of femoropopliteal disease: twelve-month outcomes from the randomized ILLUMENATE pivotal and pharmacokinetic studies. Circulation 2017; 136 (12) 1102-1113
    CrossrefPubMedGoogle Scholar
  • 21 Brodmann M, Werner M, Meyer DR. et al; ILLUMENATE EU RCT Investigators. Sustainable antirestenosis effect with a low-dose drug-coated balloon: the ILLUMENATE Euro- pean randomized clinical trial 2-year results. JACC Cardiovasc Interv 2018; 11 (23) 2357-2364
    CrossrefPubMedGoogle Scholar
  • 22 Gray WA, Jaff MR, Parikh SA. et al. Mortality assessment of paclitaxel- coated balloons: patient-level meta-analysis of the ILLUMENATE clinical program at 3 years. Circulation 2019; 140 (14) 1145-1155
    CrossrefPubMedGoogle Scholar
  • 23 Teichgräber U, Lehmann T, Aschenbach R. et al. Two-year review on mortality and morbidity after femoropopliteal drug-coated balloon angioplasty in the Randomized EffPac Trial. Radiology 2020; 296 (03) 638-640
    CrossrefPubMedGoogle Scholar
  • 24 Tang TY, Yap CJ, Chan SL. et al. Safety and efficacy of Luminor™ balloon and Angiolite™ stent on TASC C/D tibial occlusive lesions in CLI patients: 12-month results. The MERLION trial. Int Angiol 2021; 40 (04) 335-344
    PubMedGoogle Scholar
  • 25 Teichgräber U, Lehmann T, Ingwersen M. et al. Long-term effectiveness and safety of femoropopliteal drug-coated balloon angioplasty: 5-year results of the Randomized Controlled EffPac Trial. Cardiovasc Intervent Radiol 2022; 45 (12) 1774-1783
    CrossrefPubMedGoogle Scholar
  • 26 Krishnan P, Purushothaman KR, Purushothaman M. et al. Histological features of restenosis associated with paclitaxel drug-coated balloon: implications for therapy. Cardiovasc Pathol 2019; 43: 107139
    CrossrefPubMedGoogle Scholar
  • 27 Gray WA, Keirse K, Soga Y. et al; IMPERIAL Investigators. A polymer-coated, paclitaxel-eluting stent (Eluvia) versus a polymer-free, paclitaxel-coated stent (Zilver PTX) for endovascular femoropopliteal intervention (IMPERIAL): a randomised, non-inferiority trial. Lancet 2018; 392 (10157): 1541-1551
    CrossrefPubMedGoogle Scholar
  • 28 Müller-Hülsbeck S, Keirse K, Zeller T, Schroë H, Diaz-Cartelle J. Long-term results from the MAJESTIC trial of the Eluvia paclitaxel-eluting stent for femoropopliteal treatment: 3-year follow-up. Cardiovasc Intervent Radiol 2017; 40 (12) 1832-1838
    CrossrefPubMedGoogle Scholar
  • 29 Katsanos K, Spiliopoulos S, Kitrou P, Krokidis M, Karnabatidis D. Risk of death following application of paclitaxel-coated balloons and stents in the femoropopliteal artery of the leg: a systematic review and meta-analysis of randomized controlled trials. J Am Heart Assoc 2018; 7 (24) e011245
    CrossrefPubMedGoogle Scholar
  • 30 Kim TI, Kiwan G, Mohamedali A. et al. Outcomes of treatment with paclitaxel-coated devices for peripheral arterial disease. J Vasc Surg 2021; 73 (03) 911-917
    CrossrefPubMedGoogle Scholar
  • 31 Shishehbor MH, Secemsky EA, Varcoe RL. Is there a real association between paclitaxel devices and mortality? Time to pause and reevaluate what we know about this statistical finding. J Am Heart Assoc 2019; 8 (10) e012524
    CrossrefPubMedGoogle Scholar
  • 32 Wang J, Chen X, Zhao J, Zhang WW. Systematic review and meta-analysis of the outcomes of drug-eluting stent versus drug-coated balloon angioplasty for lower extremity peripheral artery diseases. Ann Vasc Surg 2022; 85: 1-8.e5
    CrossrefPubMedGoogle Scholar
  • 33 Dake MD, Ansel GM, Bosiers M. et al. Paclitaxel-coated Zilver PTX drug-eluting stent treatment does not result in increased long-term all-cause mortality compared to uncoated devices. Cardiovasc Intervent Radiol 2020; 43 (01) 8-19
    CrossrefPubMedGoogle Scholar
  • 34 Secemsky EA, Kundi H, Weinberg I. et al. Association of survival with femoropopliteal artery revascularization with drug-coated devices. JAMA Cardiol 2019; 4 (04) 332-340
    CrossrefPubMedGoogle Scholar
  • 35 Secemsky EA, Kundi H, Weinberg I. et al. Drug-eluting stent implantation and long-term survival following peripheral artery revascularization. J Am Coll Cardiol 2019; 73 (20) 2636-2638
    CrossrefPubMedGoogle Scholar
  • 36 Liistro F, Angioli P, Porto I. et al. Drug-eluting balloon versus drug-eluting stent for complex femoropopliteal arterial lesions: the DRASTICO study. J Am Coll Cardiol 2019; 74 (02) 205-215
    CrossrefPubMedGoogle Scholar
  • 37 Bausback Y, Wittig T, Schmidt A. et al. Drug-eluting stent versus drug-coated balloon revascularization in patients with femoropopliteal arterial disease. J Am Coll Cardiol 2019; 73 (06) 667-679
    CrossrefPubMedGoogle Scholar
  • 38 Marzlin N, Jan MF, Kostopoulos L, Moreno ACP, Bajwa T, Allaqaband SQ. Peripheral artery disease intervention: drug-coated balloon vs drug-eluting stent, a long-term comparison. J Interv Cardiol 2022; 2022: 5175607
    CrossrefPubMedGoogle Scholar
  • 39 Koifman E, Lipinski MJ, Buchanan K. et al. Comparison of treatment strategies for femoro-popliteal disease: a network meta-analysis. Catheter Cardiovasc Interv 2018; 91 (07) 1320-1328
    CrossrefPubMedGoogle Scholar
  • 40 Sridharan ND, Boitet A, Smith K. et al. Cost-effectiveness analysis of drug-coated therapies in the superficial femoral artery. J Vasc Surg 2018; 67 (01) 343-352
    CrossrefPubMedGoogle Scholar
  • 41 Deloose K, Callaert J. Less is more: the “As Less As Reasonably Achievable Stenting” (ALARAS) strategy in the femoropopliteal area. J Cardiovasc Surg (Torino) 2018; 59 (04) 495-503
    PubMedGoogle Scholar
  • 42 Schroë H, Holden AH, Gouëffic Y. et al. Stellarex drug-coated balloon for treatment of femoropopliteal arterial disease - the ILLUMENATE Global Study: 12-month results from a prospective, multicenter, single-arm study. Catheter Cardiovasc Interv 2018; 91 (03) 497-504
    CrossrefPubMedGoogle Scholar
  • 43 Tepe G, Zeller T, Schnorr B. et al. High-grade, non-flow-limiting dissections do not negatively impact long-term outcome after paclitaxel-coated balloon angioplasty: an additional analysis from the THUNDER study. J Endovasc Ther 2013; 20 (06) 792-800
    CrossrefPubMedGoogle Scholar
  • 44 Shishehbor MH, Scheinert D, Jain A. et al. Comparison of drug-coated balloons vs bare-metal stents in patients with femoropopliteal arterial disease. J Am Coll Cardiol 2023; 81 (03) 237-249
    CrossrefPubMedGoogle Scholar
  • 45 Lee YJ, Kook H, Ko YG. et al. Drug eluting stent vs. drug coated balloon for native femoropopliteal artery disease: a two centre experience. Eur J Vasc Endovasc Surg 2021; 61 (02) 287-295
    CrossrefPubMedGoogle Scholar
  • 46 Castro-Dominguez Y, Smolderen KG, Pichert M. et al. Patient-level and external factors in the use of drug-coated balloons and drug-eluting stents in femoropopliteal endovascular interventions. J Vasc Surg 2022; 76 (06) 1675-1680
    CrossrefPubMedGoogle Scholar
  • 47 Phair J, Carnevale M, Lipsitz EC. et al. Amputation-free survival in patients with critical limb ischemia treated with paclitaxel-eluting stents and paclitaxel-coated balloons. Ann Vasc Surg 2020; 62: 8-14
    CrossrefPubMedGoogle Scholar