Semin intervent Radiol 2022; 39(01): 056-065
DOI: 10.1055/s-0042-1742483
Review Article

Drug-Coated Balloons for the Dysfunctional Vascular Access: An Evidence-Based Road Map to Treatment and the Existing Obstacles

Panagiotis Kitrou
1   Department of Interventional Radiology, Patras University Hospital, Patras, Greece
,
Konstantinos Katsanos
1   Department of Interventional Radiology, Patras University Hospital, Patras, Greece
,
Georgia Andriana Georgopoulou
2   Department of Nephrology, Patras University Hospital, Patras, Greece
,
Dimitrios Karnabatidis
1   Department of Interventional Radiology, Patras University Hospital, Patras, Greece
› Author Affiliations

Abstract

An underlying stenosis within the venous limb of a hemodialysis access circuit is the main etiology for graft and fistula dysfunction as well as other symptoms such as arm, breast, and neck swelling. Treatment options for both peripheral and central venous stenoses include plain old balloon angioplasty, angioplasty with drug-coated balloons, and stenting. This article discusses the current evidence for the use of drug-coated balloon angioplasty in this patient population.



Publication History

Article published online:
18 February 2022

© 2022. Thieme. All rights reserved.

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  • References

  • 1 Lok CE, Huber TS, Lee T. et al; National Kidney Foundation. KDOQI clinical practice guideline for vascular access: 2019 update. Am J Kidney Dis 2020; 75 (4, Suppl 2): S1-S164
  • 2 Agarwal AK. Central vein stenosis. Am J Kidney Dis 2013; 61 (06) 1001-1015
  • 3 Roy-Chaudhury P, Sukhatme VP, Cheung AK. Hemodialysis vascular access dysfunction: a cellular and molecular viewpoint. J Am Soc Nephrol 2006; 17 (04) 1112-1127
  • 4 Katsanos K, Karnabatidis D, Kitrou P, Spiliopoulos S, Christeas N, Siablis D. Paclitaxel-coated balloon angioplasty vs. plain balloon dilation for the treatment of failing dialysis access: 6-month interim results from a prospective randomized controlled trial. J Endovasc Ther 2012; 19 (02) 263-272
  • 5 Kitrou PM, Katsanos K, Spiliopoulos S, Karnabatidis D, Siablis D. Drug-eluting versus plain balloon angioplasty for the treatment of failing dialysis access: final results and cost-effectiveness analysis from a prospective randomized controlled trial (NCT01174472). Eur J Radiol 2015; 84 (03) 418-423
  • 6 Patanè D, Giuffrida S, Morale W. et al. Drug-eluting balloon for the treatment of failing hemodialytic radiocephalic arteriovenous fistulas: our experience in the treatment of juxta-anastomotic stenoses. J Vasc Access 2014; 15 (05) 338-343
  • 7 Lai CC, Fang HC, Tseng CJ, Liu CP, Mar GY. Percutaneous angioplasty using a paclitaxel-coated balloon improves target lesion restenosis on inflow lesions of autogenous radiocephalic fistulas: a pilot study. J Vasc Interv Radiol 2014; 25 (04) 535-541
  • 8 Kitrou PM, Spiliopoulos S, Katsanos K, Papachristou E, Siablis D, Karnabatidis D. Paclitaxel-coated versus plain balloon angioplasty for dysfunctional arteriovenous fistulae: one-year results of a prospective randomized controlled trial. J Vasc Interv Radiol 2015; 26 (03) 348-354
  • 9 Massmann A, Fries P, Obst-Gleditsch K, Minko P, Shayesteh-Kheslat R, Buecker A. Paclitaxel-coated balloon angioplasty for symptomatic central vein restenosis in patients with hemodialysis fistulas. J Endovasc Ther 2015; 22 (01) 74-79
  • 10 Swinnen JJ, Zahid A, Burgess DC. Paclitaxel drug-eluting balloons to recurrent in-stent stenoses in autogenous dialysis fistulas: a retrospective study. J Vasc Access 2015; 16 (05) 388-393
  • 11 Verbeeck N, Pillet JC, Toukouki A, Prospert F, Leite S, Mathieu X. Paclitaxel-coated balloon angioplasty of venous stenoses in native dialysis fistulas: primary and secondary patencies at 6 and 12 months. J Belg Soc Radiol 2016; 100 (01) 69
  • 12 Kitrou PM, Spiliopoulos S, Papadimatos P. et al. Paclitaxel-coated balloons for the treatment of dysfunctional dialysis access. results from a single-center, retrospective analysis. Cardiovasc Intervent Radiol 2017; 40 (01) 50-54
  • 13 Maleux G, Vander Mijnsbrugge W, Henroteaux D. et al. Multicenter, randomized trial of conventional balloon angioplasty versus paclitaxel-coated balloon angioplasty for the treatment of dysfunctioning autologous dialysis fistulae. J Vasc Interv Radiol 2018; 29 (04) 470-475.e3
  • 14 Roosen LJ, Karamermer Y, Vos JA, de Jong GM, Bos WJ, Elgersma OE. Paclitaxel-coated balloons do not prevent recurrent stenosis in hemodialysis access fistulae: results of a randomized clinical trial. Ital J Vasc Endovasc Surg 2017; 24 (02) 35-40
  • 15 Kitrou PM, Papadimatos P, Spiliopoulos S. et al. Paclitaxel-coated balloons for the treatment of symptomatic central venous stenosis in dialysis access: results from a randomized controlled trial. J Vasc Interv Radiol 2017; 28 (06) 811-817
  • 16 Troisi N, Frosini P, Romano E, Guidotti A, Chisci E, Michelagnoli S. Freeway paclitaxel-releasing balloons to treat recurrent stenosis of arteriovenous fistula in hemodialysis patients. Minerva Cardioangiol 2018; 66 (03) 233-237
  • 17 Ierardi AM, Franchin M, Fontana F. et al. Usefulness of paclitaxel-releasing high-pressure balloon associated with cutting balloon angioplasty for treatment of outflow stenoses of failing hemodialysis arteriovenous shunts. Radiol Med (Torino) 2017; 122 (01) 69-76
  • 18 Trerotola SO, Lawson J, Roy-Chaudhury P, Saad TF. Lutonix AV Clinical Trial Investigators. Drug coated balloon angioplasty in failing AV fistulas: a randomized controlled trial. Clin J Am Soc Nephrol 2018; 13 (08) 1215-1224
  • 19 Trerotola SO, Saad TF, Roy-Chaudhury P. Lutonix AV Clinical Trial Investigators. The Lutonix AV randomized trial of paclitaxel-coated balloons in arteriovenous fistula stenosis: 2-year results and subgroup analysis. J Vasc Interv Radiol 2020; 31 (01) 1-14.e5
  • 20 Irani FG, Teo TKB, Tay KH. et al. Hemodialysis arteriovenous fistula and graft stenoses: randomized trial comparing drug-eluting balloon angioplasty with conventional angioplasty. Radiology 2018; 289 (01) 238-247
  • 21 Lučev J, Breznik S, Dinevski D, Ekart R, Rupreht M. Endovascular treatment of haemodialysis arteriovenous fistula with drug-coated balloon angioplasty: a single-centre study. Cardiovasc Intervent Radiol 2018; 41 (06) 882-889
  • 22 Hongsakul K, Bannangkoon K, Rookkapan S, Boonsrirat U, Kritpracha B. Paclitaxel-coated balloon angioplasty for early restenosis of central veins in hemodialysis patients: a single center initial experience. Korean J Radiol 2018; 19 (03) 410-416
  • 23 Swinnen JJ, Hitos K, Kairaitis L. et al. Multicentre, randomised, blinded, control trial of drug-eluting balloon vs Sham in recurrent native dialysis fistula stenoses. J Vasc Access 2019; 20 (03) 260-269
  • 24 Kitrou PM, Katsanos K, Spyridonidis I. et al. Use of drug-coated balloons in dysfunctional arteriovenous dialysis access treatment: the effect of consecutive treatments on lesion patency. J Vasc Interv Radiol 2019; 30 (02) 212-216
  • 25 Gulcu A, Sarioglu O, Peker A, Alatas O. Drug-eluting balloon angioplasty for juxta-anastomotic stenoses in distal radiocephalic hemodialysis fistulas: long-term patency results. Cardiovasc Intervent Radiol 2019; 42 (06) 835-840
  • 26 Björkman P, Weselius EM, Kokkonen T, Rauta V, Albäck A, Venermo M. Drug-coated versus plain balloon angioplasty in arteriovenous fistulas: a randomized, controlled study with 1-year follow-up (the Drecorest II-Study). Scand J Surg 2019; 108 (01) 61-66
  • 27 Tozzi M, Franchin M, Savio D. et al. Drug-coated balloon angioplasty in failing haemodialysis arteriovenous shunts: 12-month outcomes in 200 patients from the Aperto Italian registry. J Vasc Access 2019; 20 (06) 733-739
  • 28 Kocaaslan C, Oztekin A, Bademci MS, Denli Yalvac ES, Bulut N, Aydin E. A retrospective comparison analysis of results of drug-coated balloon versus plain balloon angioplasty in treatment of juxta-anastomotic de novo stenosis of radiocephalic arteriovenous fistulas. J Vasc Access 2020; 21 (05) 596-601
  • 29 Karnabatidis D, Kitrou PM, Ponce P. et al; Lutonix AV Global Registry Investigators. A multicenter global registry of paclitaxel drug-coated balloon in dysfunctional arteriovenous fistulae and grafts: 6-month results. J Vasc Interv Radiol 2021; 32 (03) 360-368.e2
  • 30 Moreno-Sánchez T, Moreno-Ramírez M, Machancoses FH, Pardo-Moreno P, Navarro-Vergara PF, García-Revillo J. Efficacy of paclitaxel balloon for hemodialysis stenosis fistulae after one year compared to high-pressure balloons: a controlled, multicenter, randomized trial. Cardiovasc Intervent Radiol 2020; 43 (03) 382-390
  • 31 Liao MT, Lee CP, Lin TT. et al. A randomized controlled trial of drug-coated balloon angioplasty in venous anastomotic stenosis of dialysis arteriovenous grafts. J Vasc Surg 2020; 71 (06) 1994-2003
  • 32 Kitrou PM, Steinke T, El Hage R. et al. Paclitaxel-coated balloons for the treatment of symptomatic central venous stenosis in vascular access: results from a European, multicenter, single-arm retrospective analysis. J Endovasc Ther 2021; 28 (03) 442-451
  • 33 Lookstein RA, Haruguchi H, Ouriel K. et al; IN.PACT AV Access Investigators. Drug-coated balloons for dysfunctional dialysis arteriovenous fistulas. N Engl J Med 2020; 383 (08) 733-742
  • 34 Kim JW, Kim JH, Byun SS, Kang JM, Shin JH. Paclitaxel-coated balloon versus plain balloon angioplasty for dysfunctional autogenous radiocephalic arteriovenous fistulas: a prospective randomized controlled trial. Korean J Radiol 2020; 21 (11) 1239-1247
  • 35 Pang SYC, Au-Yeung KCL, Liu GYL. et al. Randomized controlled trial for paclitaxel-coated balloon versus plain balloon angioplasty in dysfunctional hemodialysis vascular access: 12-month outcome from a nonsponsored trial. Ann Vasc Surg 2021; 72: 299-306
  • 36 Chong TT, Yap HY, Tan CS. et al. Use of paclitaxel coated drug eluting technology to improve central vein patency for haemodialysis access circuits: Any benefit?. Vasc Spec Int 2020; 36 (01) 21-27
  • 37 Karunanithy N, Robinson EJ, Ahmad F. et al. A multicenter randomized controlled trial indicates that paclitaxel-coated balloons provide no benefit for arteriovenous fistulas. Kidney Int 2021; 100 (02) 447-456
  • 38 Therasse E, Caty V, Gilbert P. et al. Safety and efficacy of paclitaxel-eluting balloon angioplasty for dysfunctional hemodialysis access: a randomized trial comparing with angioplasty alone. J Vasc Interv Radiol 2021; 32 (03) 350-359.e2
  • 39 Yin Y, Shi Y, Cui T. et al. Efficacy and safety of paclitaxel-coated balloon angioplasty for dysfunctional arteriovenous fistulas: a multicenter randomized controlled trial. Am J Kidney Dis 2021; 78 (01) 19-27.e1
  • 40 Trerotola SO, Roy-Chaudhury P, Saad TF. Drug-coated balloon angioplasty in failing arteriovenous fistulas: more data, less clarity. Am J Kidney Dis 2021; 78 (01) 13-15
  • 41 Jaffer O, Gibbs P, Gibson M. et al. A UK expert consensus approach for managing symptomatic arteriovenous fistula (AVF) stenosis in haemodialysis patients. Cardiovasc Intervent Radiol 2021; 44 (11) 1736-1746
  • 42 Karnabatidis D, Kitrou P. Drug eluting balloons for resistant arteriovenous dialysis access stenosis. J Vasc Access 2017; 18 (Suppl. 01) 88-91
  • 43 Haskal ZJ, Trerotola S, Dolmatch B. et al. Stent graft versus balloon angioplasty for failing dialysis-access grafts. N Engl J Med 2010; 362 (06) 494-503
  • 44 Vesely T, DaVanzo W, Behrend T, Dwyer A, Aruny J. Balloon angioplasty versus Viabahn stent graft for treatment of failing or thrombosed prosthetic hemodialysis grafts. J Vasc Surg 2016; 64 (05) 1400-1410.e1
  • 45 Kitrou PM, Katsanos K, Karnabatidis D. New evidence to support the use of drug coated balloons in the treatment of dysfunctional vascular access. Eur J Vasc Endovasc Surg 2021; 61 (04) 540-541
  • 46 Kennedy SA, Mafeld S, Baerlocher MO, Jaberi A, Rajan DK. Drug-coated balloon angioplasty in hemodialysis circuits: a systematic review and meta-analysis. J Vasc Interv Radiol 2019; 30 (04) 483-494.e1
  • 47 Abdul Salim S, Tran H, Thongprayoon C, Fülöp T, Cheungpasitporn W. Comparison of drug-coated balloon angioplasty versus conventional angioplasty for arteriovenous fistula stenosis: Systematic review and meta-analysis. J Vasc Access 2020; 21 (03) 357-365
  • 48 Cao Z, Li J, Zhang T. et al. Comparative effectiveness of drug-coated balloon vs balloon angioplasty for the treatment of arteriovenous fistula stenosis: a meta-analysis. J Endovasc Ther 2020; 27 (02) 266-275
  • 49 Liao MT, Chen MK, Hsieh MY. et al. Drug-coated balloon versus conventional balloon angioplasty of hemodialysis arteriovenous fistula or graft: a systematic review and meta-analysis of randomized controlled trials. PLoS One 2020; 15 (04) e0231463
  • 50 Katsanos K, Spiliopoulos S, Teichgräber U. et al. Risk of major amputation following application of paclitaxel coated balloons in the lower limb arteries: a systematic review and meta-analysis of randomised controlled trials. Eur J Vasc Endovasc Surg 2021; S1078-5884 (21)00443-3
  • 51 Katsanos K, Kitrou P, Spiliopoulos S. The rollercoaster of paclitaxel in the lower limbs and skeletons in the closet: an opinion review. J Vasc Interv Radiol 2021; 32 (06) 785-791
  • 52 Katsanos K, Spiliopoulos S, Kitrou P, Krokidis M, Paraskevopoulos I, Karnabatidis D. Risk of death and amputation with use of paclitaxel-coated balloons in the infrapopliteal arteries for treatment of critical limb ischemia: a systematic review and meta-analysis of randomized controlled trials. J Vasc Interv Radiol 2020; 31 (02) 202-212
  • 53 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
  • 54 2018 USRDS annual data report: epidemiology of kidney disease in the United States. Accessed January 5, 2022: https://usrdsorg/media/1730/v2_c05_mortality_18_usrdspdf 2018
  • 55 Hu H, Tan Q, Wang J, Liu Y, Yang Y, Zhao J. Drug-coated balloon angioplasty for failing haemodialysis access: meta-analysis of randomized clinical trials. Br J Surg 2021; 108 (11) 1293-1303