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The Role of Drug-Coated Balloon in Haemodialysis Arteriovenous Fistula Stenosis Management

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Abstract

Arteriovenous fistula (AVF) stenosis is a common problem leading to dialysis access dysfunction. The conventional balloon (CB) is the most commonly used device during angioplasty but suffers from poor durability of results due to neointimal hyperplasia-mediated recurrence. The drug-coated balloon (DCB) is an adjunct to balloon angioplasty that reduces neointimal hyperplasia, thereby improving post-angioplasty patency. Despite the heterogeneity of DCB clinical trials to date, the evidence suggests that DCBs of different brands are not necessarily equal, and that patient selection, adequate lesion preparation and proper DCB procedural technique are important to realize the benefit of DCB angioplasty.

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References

  1. Roy-Chaudhury P, Sukhatme VP, Cheung AK. Hemodialysis vascular access dysfunction: a cellular and molecular viewpoint. JASN. 2006;17(4):1112–27. https://doi.org/10.1681/ASN.2005050615.

    Article  PubMed  Google Scholar 

  2. Lookstein RA, Haruguchi H, Ouriel K, et al. Drug-coated balloons for dysfunctional dialysis arteriovenous fistulas. N Engl J Med. 2020;383(8):733–42. https://doi.org/10.1056/NEJMoa1914617.

    Article  CAS  PubMed  Google Scholar 

  3. Holden A, Haruguchi H, Suemitsu K, et al. IN.PACT AV access randomized trial: 12-month clinical results demonstrating the sustained treatment effect of drug-coated balloons. J Vasc Interv Radiol. 2022;33(8):884-94. https://doi.org/10.1016/j.jvir.2022.03.606.

    Article  PubMed  Google Scholar 

  4. 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(1):238–47. https://doi.org/10.1148/radiol.2018170806.

    Article  PubMed  Google Scholar 

  5. Björkman P, Weselius E-M, 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(1):61–6. https://doi.org/10.1177/1457496918798206.

    Article  PubMed  Google Scholar 

  6. 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(4):470–75. https://doi.org/10.1016/j.jvir.2017.10.023.

    Article  PubMed  Google Scholar 

  7. 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(2):35–40. https://doi.org/10.23736/S1824-4777.17.01282-7.

    Article  Google Scholar 

  8. Trerotola SO, Lawson J, Roy-Chaudhury P, Saad TF. Drug coated balloon angioplasty in failing AV fistulas: a randomized controlled trial. CJASN. 2018;13(8):1215–24. https://doi.org/10.2215/CJN.14231217.

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  9. Trerotola SO, Saad TF, Roy-Chaudhury P. 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(1):1-4. https://doi.org/10.1016/j.jvir.2019.08.035.

    Article  PubMed  Google Scholar 

  10. 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(2):447–56. https://doi.org/10.1016/j.kint.2021.02.040.

    Article  CAS  PubMed  Google Scholar 

  11. 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 Interv Radiol. 2020;43(3):382–90. https://doi.org/10.1007/s00270-019-02372-w.

    Article  Google Scholar 

  12. 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(3):350-59. https://doi.org/10.1016/j.jvir.2020.10.030.

    Article  PubMed  Google Scholar 

  13. Pisoni RL, Zepel L, Zhao J, et al. International comparisons of native arteriovenous fistula patency and time to becoming catheter-free: findings from the dialysis outcomes and practice patterns study (DOPPS). Am J Kidney Dis. 2021;77(2):245–54. https://doi.org/10.1053/j.ajkd.2020.06.020.

    Article  PubMed  Google Scholar 

  14. Schorn I, Malinoff H, Anderson S, et al. The lutonix® drug-coated balloon: a novel drug delivery technology for the treatment of vascular disease. Adv Drug Deliv Rev. 2017;112:78–87. https://doi.org/10.1016/j.addr.2017.05.015.

    Article  CAS  PubMed  Google Scholar 

  15. Karnabatidis D, Kitrou PM, Ponce P, et al. A multicenter global registry of paclitaxel drug-coated balloon in dysfunctional arteriovenous fistulae and grafts: 6-month results. J Vasc Interv Radiol. 2021;32(3):360–68. https://doi.org/10.1016/j.jvir.2020.11.018.

    Article  PubMed  Google Scholar 

  16. Bastian H, Glasziou P, Chalmers I. Seventy-five trials and eleven systematic reviews a day: how will we ever keep up? PLoS Med. 2010;7(9):e1000326. https://doi.org/10.1371/journal.pmed.1000326.

    Article  PubMed  PubMed Central  Google Scholar 

  17. 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(4):483-94. https://doi.org/10.1016/j.jvir.2019.01.012.

    Article  PubMed  Google Scholar 

  18. 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(3):357–65. https://doi.org/10.1177/1129729819878612.

    Article  PubMed  Google Scholar 

  19. Liao M-T, Chen M-K, Hsieh M-Y, 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(4):e0231463. https://doi.org/10.1371/journal.pone.0231463.

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  20. Fong KY, Zhao JJ, Tan E, et al. Drug coated balloons for dysfunctional haemodialysis venous access: a patient level meta-analysis of randomised controlled trials. Eur J Vasc Endovasc Surg. 2021;62(4):610–21. https://doi.org/10.1016/j.ejvs.2021.06.006.

    Article  PubMed  Google Scholar 

  21. Han A, Park T, Kim HJ, Min S, Ha J, Min S-K. Editor’s choice–paclitaxel coated balloon angioplasty vs. plain balloon angioplasty for haemodialysis arteriovenous access stenosis: a systematic review and a time to event meta-analysis of randomised controlled trials. Eur J Vasc Endovasc Surg. 2021;62(4):597–609. https://doi.org/10.1016/j.ejvs.2021.05.043.

    Article  PubMed  Google Scholar 

  22. Luo C, Liang M, Liu Y, Zheng D, He Q, Jin J. Paclitaxel coated balloon versus conventional balloon angioplasty in dysfunctional dialysis arteriovenous fistula: a systematic review and meta-analysis of randomized controlled trials. Ren Fail. 2022;44(1):155–70. https://doi.org/10.1080/0886022X.2022.2029487.

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  23. 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. https://doi.org/10.1161/JAHA.118.011245.

    Article  PubMed  PubMed Central  Google Scholar 

  24. Behrendt C-A, Sedrakyan A, Peters F, et al. Editor’s choice – long term survival after femoropopliteal artery revascularisation with paclitaxel coated devices: a propensity score matched cohort analysis. Eur J Vasc Endovasc Surg. 2020;59(4):587–96. https://doi.org/10.1016/j.ejvs.2019.12.034.

    Article  PubMed  Google Scholar 

  25. Secemsky EA, Shen C, Schermerhorn M, Yeh RW. Longitudinal assessment of safety of femoropopliteal endovascular treatment with paclitaxel-coated devices among medicare beneficiaries: the SAFE-PAD study. JAMA Intern Med. 2021;181(8):1071. https://doi.org/10.1001/jamainternmed.2021.2738.

    Article  PubMed  Google Scholar 

  26. Ko DS, Bae GH, Choi ST, Jung J, Kang JM. Mortality is not associated with paclitaxel-coated devices usage in peripheral arterial disease of lower extremities. Sci Rep. 2021;11(1):18214. https://doi.org/10.1038/s41598-021-97675-9.

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  27. Dinh K, Limmer AM, Paravastu SCV, et al. Mortality after paclitaxel-coated device use in dialysis access: a systematic review and meta-analysis. J Endovasc Ther. 2019;26(5):600–12. https://doi.org/10.1177/1526602819872154.

    Article  PubMed  Google Scholar 

  28. Milewski K, Afari ME, Tellez A, et al. Evaluation of efficacy and dose response of different paclitaxel-coated balloon formulations in a novel swine model of iliofemoral in-stent restenosis. JACC Cardiovasc Interv. 2012;5(10):1081–8. https://doi.org/10.1016/j.jcin.2012.06.012.

    Article  PubMed  Google Scholar 

  29. Gemeinhardt O, Haase T, Schnorr B, et al. Improvement of outcome for treatment of “restenosis-prone” vascular lesions? Potential impact of the paclitaxel dose on late lumen loss in porcine peripheral arteries. Cardiovasc Interv Radiol. 2022;45(12):1822–31. https://doi.org/10.1007/s00270-022-03277-x.

    Article  Google Scholar 

  30. Chang GH, Azar DA, Lyle C, Chitalia VC, Shazly T, Kolachalama VB. Intrinsic coating morphology modulates acute drug transfer in drug-coated balloon therapy. Sci Rep. 2019;9(1):6839. https://doi.org/10.1038/s41598-019-43095-9.

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  31. Radke PW, Joner M, Joost A, et al. Vascular effects of paclitaxel following drug-eluting balloon angioplasty in a porcine coronary model: the importance of excipients. EuroIntervention. 2011;7(6):730–7. https://doi.org/10.4244/EIJV7I6A116.

    Article  PubMed  Google Scholar 

  32. Boitet A, Grassin-Delyle S, Louedec L, et al. An experimental study of paclitaxel embolisation during drug coated balloon angioplasty. Eur J Vasc Endovasc Surg. 2019;57(4):578–86. https://doi.org/10.1016/j.ejvs.2018.11.019.

    Article  PubMed  Google Scholar 

  33. Granada JF, Stenoien M, Buszman PP, et al. Mechanisms of tissue uptake and retention of paclitaxel-coated balloons: impact on neointimal proliferation and healing. Open Heart. 2014;1(1):e000117. https://doi.org/10.1136/openhrt-2014-000117.

    Article  PubMed  PubMed Central  Google Scholar 

  34. Kolodgie FD, Pacheco E, Yahagi K, Mori H, Ladich E, Virmani R. Comparison of particulate embolization after femoral artery treatment with IN.PACT admiral versus lutonix 035 paclitaxel-coated balloons in healthy swine. J Vasc Interv Radiol. 2016;27(11):1676–85. https://doi.org/10.1016/j.jvir.2016.06.036.

    Article  PubMed  Google Scholar 

  35. Faenger B, Heinrich A, Hilger I, Teichgräber U. Drug loss from paclitaxel-coated balloons during preparation, insertion and inflation for angioplasty: a laboratory investigation. Cardiovasc Interv Radiol. 2022;45(8):1186–97. https://doi.org/10.1007/s00270-022-03164-5.

    Article  Google Scholar 

  36. Irani FG, Tan BS. Drug coated balloons: are they the holy grail for dysfunctional dialysis arteriovenous fistulas? Cardiovasc Interv Radiol. 2021;44(3):516–7. https://doi.org/10.1007/s00270-020-02690-4.

    Article  Google Scholar 

  37. Lee HS, Kang J, Park KW, et al. Procedural optimization of drug-coated balloons in the treatment of coronary artery disease. Catheter Cardiovasc Interv. 2021;98(1):E43–55. https://doi.org/10.1002/ccd.29492.

    Article  PubMed  Google Scholar 

  38. Kitrou P, Katsanos K, Georgopoulou GA, Karnabatidis D. Drug-coated balloons for the dysfunctional vascular access: an evidence-based road map to treatment and the existing obstacles. Semin Interv Radiol. 2022;39(1):56–65. https://doi.org/10.1055/s-0042-1742483.

    Article  Google Scholar 

  39. Trerotola SO, Kwak A, Clark TWI, et al. Prospective study of balloon inflation pressures and other technical aspects of hemodialysis access angioplasty. J Vasc Interv Radiol. 2005;16(12):1613–8. https://doi.org/10.1097/01.RVI.0000183588.57568.36.

    Article  PubMed  Google Scholar 

  40. 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(2):263–72. https://doi.org/10.1583/11-3690.1.

    Article  PubMed  Google Scholar 

  41. DePietro DM, Trerotola SO. Choosing the right treatment for the right lesion, part I: a narrative review of the role of plain balloon angioplasty in dialysis access maintenance. Cardiovasc Diagn Ther. 2023;13(1):212–32. https://doi.org/10.21037/cdt-22-375.

    Article  PubMed  Google Scholar 

  42. Sidhu A, Tan KT, Noel-Lamy M, Simons ME, Rajan DK. Does technical success of angioplasty in dysfunctional hemodialysis accesses correlate with access patency? Cardiovasc Interv Radiol. 2016;39(10):1400–6. https://doi.org/10.1007/s00270-016-1401-7.

    Article  Google Scholar 

  43. Zhu Z-R, Zou L, Xing Y, et al. Predictors of primary patency after percutaneous balloon angioplasty for stenosis of Brescia-Cimino hemodialysis arteriovenous fistula. Br J Radiol. 2020;93(1109):20190505. https://doi.org/10.1259/bjr.20190505.

    Article  PubMed  PubMed Central  Google Scholar 

  44. Tang TY, Soon SXY, Yap CJQ, Chan SL, Choke ETC, Chong TT. Utility of sirolimus coated balloons for salvaging dysfunctional arteriovenous fistulae: one year results from the MATILDA trial. Eur J Vasc Endovasc Surg. 2021;62(2):316–7. https://doi.org/10.1016/j.ejvs.2021.04.014.

    Article  PubMed  Google Scholar 

  45. Pang SC, Tan RY, Choke E, et al. SIroliMus coated angioPlasty versus plain balloon angioplasty in the tREatment of dialySis acceSs dysfunctION (IMPRESSION): study protocol for a randomized controlled trial. Trials. 2021;22(1):945. https://doi.org/10.1186/s13063-021-05920-3.

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  46. Pietzsch JB, Geisler BP, Manda B, et al. IN.PACT AV access trial: economic evaluation of drug-coated balloon treatment for dysfunctional arteriovenous fistulae based on 12-month clinical outcomes. J Vasc Interv Radiol. 2022;33(8):895-902.e4. https://doi.org/10.1016/j.jvir.2022.04.014.

    Article  PubMed  Google Scholar 

  47. Lau CCA, Irani F, Shi L, et al. Cost-effectiveness of drug-coated balloon angioplasty compared with conventional balloon angioplasty for arteriovenous access flow dysfunction. Value Health Reg Issues. 2022;31:155–62. https://doi.org/10.1016/j.vhri.2022.05.002.

    Article  PubMed  Google Scholar 

  48. 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(3):418–23. https://doi.org/10.1016/j.ejrad.2014.11.037.

    Article  PubMed  Google Scholar 

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  1. Department of Vascular and Interventional Radiology, Singapore General Hospital, Outram Road, Singapore, 169608, Singapore

    Kun Da Zhuang, Farah Gillan Irani, Apoorva Gogna, Chow Wei Too, Bien Soo Tan & Kiang Hiong Tay

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  1. Kun Da Zhuang
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Da Zhuang, K., Irani, F.G., Gogna, A. et al. The Role of Drug-Coated Balloon in Haemodialysis Arteriovenous Fistula Stenosis Management. Cardiovasc Intervent Radiol 46, 1144–1153 (2023). https://doi.org/10.1007/s00270-023-03497-9

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