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The Efficacy of Paclitaxel Drug-Eluting Balloon Angioplasty Versus Standard Balloon Angioplasty in Stenosis of Native Hemodialysis Arteriovenous Fistulas: An Analysis of Clinical Success, Primary Patency and Risk Factors for Recurrent Dysfunction

  • Clinical Investigation
  • Venous Interventions
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CardioVascular and Interventional Radiology Aims and scope Submit manuscript

Abstract

Purpose

To investigate the efficacy of paclitaxel drug-eluting balloons (PEB) versus standard balloon angioplasty (BA) in stenosis of native hemodialysis arteriovenous fistulas (AVFs).

Materials and Methods

A total of 96 patients with ESRD (mean ± SD age 57.0 ± 9.1 years, 63.5% were males) who underwent endovascular treatment with PEB angioplasty (n = 32) and BA (n = 64) for a dysfunctional native AVF were included. Clinical success, complications, primary patency and postoperative recurrence parameters were recorded in each group.

Results

Primary patency rate at 6 months was significantly higher in PEB than in BA group (96.9 vs. 20.3%, p < 0.001), while the two groups had similar primary patency rates at 9 months (66.8 vs. 50.0%) and 12 months (6.3% for each). No significant difference was noted between PEB and BA groups in terms of the rate (21.9% and. 31.3%), time (median 220 vs. 152.5 days) and reasons (reocclusion in 18.8 vs. 28.1%) for dysfunction recurrence as well as the number of recurrent treatments. AVF dysfunction recurrence was more likely in younger age AVF (median 4 vs. 23 months, p < 0.001 in PEB, and 8.5 vs. 20.5 months p = 0.001 in SBA) and in AVF ≤ 6 months in both SBA and PEB groups (71.4 vs. 12.0%, p = 0.005 in PEB, 40.0 vs. 2.3%, p < 0.001).

Conclusion

In conclusion, our findings emphasize favorable safety and efficacy of PEB and BA in the management of dysfunctional hemodialysis AVFs with similar rates of post-PTA recurrence of AVF dysfunction. Nonetheless, there was a nonsignificant tendency for lower rate and a delay for recurrent dysfunction in patients treated with PEB and a significant association younger AVF age with an increased risk of post-PTA recurrence of AVF dysfunction.

Level of Evidence

3, Retrospective cohort study.

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References

  1. Tonelli M, Wiebe N, Culleton B, et al. Chronic kidney disease and mortality risk: a systematic review. J Am Soc Nephrol. 2006;17:2034–47.

    Article  PubMed  Google Scholar 

  2. Tham WP, Burgmans MC, Tan BS, et al. Percutaneous endovascular treatment to salvage non-maturing arteriovenous fistulas in a multiethnic asian population. Ann Acad Med Singap. 2017;46:64–71.

    PubMed  Google Scholar 

  3. Pippias M, Stel VS, Abad Diez JM, et al. Renal replacement therapy in Europe: a summary of the 2012 ERA-EDTA Registry Annual Report. Clin Kidney J. 2015;8:248–61.

    Article  PubMed  PubMed Central  Google Scholar 

  4. Çildağ MB, Köseoğlu ÖF, Akdam H, Yeniçerioğlu Y. The primary patency of drug-eluting balloon versus conventional balloon angioplasty in hemodialysis patients with arteriovenous fistula stenoses. Jpn J Radiol. 2016;34:700–4.

    Article  CAS  PubMed  Google Scholar 

  5. Hammes M. Hemodynamic and biologic determinates of arteriovenous fistula outcomes in renal failure patients. Biomed Res Int. 2015;2015:171674.

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  6. National Kidney Foundation. KDOQI clinical practice guidelines and clinical practice recommendations for 2006 updates: hemodialysis adequacy, peritoneal dialysis adequacy and vascular access. Am J Kidney Dis. 2006;48:S1–322.

    Article  Google Scholar 

  7. Polkinghorne KR, Chin GK, Macginley RJ, et al. KHA-CARI guideline: vascular access—central venous catheters, arteriovenous fistulae and arteriovenous grafts. Nephrology. 2013;18:701–5.

    Article  PubMed  Google Scholar 

  8. Bashar K, Conlon PJ, Kheirelseid EA, Aherne T, Walsh SR, Leahy A. Arteriovenous fistula in dialysis patients: factors implicated in early and late AVF maturation failure. Surgeon. 2016;14:294–300.

    Article  PubMed  Google Scholar 

  9. Huber TS, Carter JW, Carter RL, Seeger JM. Patency of autogenous and polytetrafluoroethylene upper extremity arteriovenous hemodialysis accesses: a systematic review. J Vasc Surg. 2003;38:1005–11.

    Article  PubMed  Google Scholar 

  10. Polkinghorne KR, Mcdonald SP, Atkins RC, Kerr PG. Vascular access and all-cause mortality: a propensity score analysis. J Am Soc Nephrol. 2004;15:477–86.

    Article  PubMed  Google Scholar 

  11. Axel DI, Kunert W, Goeggelmann C, et al. Paclitaxel inhibits arterial smooth muscle cell proliferation and migration in vitro and in vivo using local drug delivery. Circulation. 1997;96:636–45.

    Article  CAS  Google Scholar 

  12. 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;358:689–99.

    Article  CAS  PubMed  Google Scholar 

  13. 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 fromthe IN.PACT SFA randomized trial. Circulation. 2015;131:495–502.

  14. Unverdorben M, Vallbracht C, Cremers B, et al. Paclitaxel-coated balloon catheter versus paclitaxel-coated stent for the treatment of coronary in-stent restenosis. Circulation. 2009;119:2986–94.

    Article  CAS  PubMed  Google Scholar 

  15. 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;373:145–53.

    Article  CAS  PubMed  Google Scholar 

  16. 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;25:535–41.

    Article  PubMed  Google Scholar 

  17. 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;19:263–72.

    Article  PubMed  Google Scholar 

  18. 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 andcost-effectiveness analysis from a prospective randomized controlled trial (NCT01174472). Eur J Radiol. 2015;84:418–23.

    Article  PubMed  Google Scholar 

  19. 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;26:348–54.

    Article  PubMed  Google Scholar 

  20. 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;28:811–7.

    Article  PubMed  Google Scholar 

  21. 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;13:1215–24.

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  22. Bountouris I, Kritikou G, Degermetzoglou N, Avgerinos KI. A review of percutaneous transluminal angioplasty in hemodialysis fistula. Int J Vasc Med. 2018;2018:1420136. Review.

  23. Portugaller RH, Kalmar PI, Deutschmann H. The eternal tale of dialysis access vessels and restenosis: are drug-eluting balloons the solution? J Vasc Access. 2014;15:439–47.

    Article  PubMed  Google Scholar 

  24. Khawaja AZ, Cassidy DB, Al Shakarchi J, McGrogan DG, Inston NG, Jones RG. Systematic review of drug eluting balloon angioplasty for arteriovenous haemodialysis access stenosis. J Vasc Access. 2016;17:103–10.

    Article  PubMed  Google Scholar 

  25. Aruny JE, Lewis CA, Cardella JF, et al. Quality improvement guidelines for percutaneous management of the thrombosed or dysfunctional dialysis access: standards of practice committee of the society of cardiovascular & interventional radiology. J Vasc Interv Radiol. 1999;10:491–8.

    Article  CAS  PubMed  Google Scholar 

  26. Gray RJ, Sacks D, Martin LG, Trerotola SO. Reporting standards for percutaneous interventions in dialysis access. J Vasc Interv Radiol. 2003;14:433–42.

    Article  Google Scholar 

  27. 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;29:470–5.

    Article  PubMed  Google Scholar 

  28. 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;41:882–9.

    Article  PubMed  Google Scholar 

  29. Rodriguez JA, Armadans L, Ferrer E, et al. The function of permanent vascular access. Nephrol Dial Transplant. 2000;15:402–8.

    Article  CAS  PubMed  Google Scholar 

  30. Sedlacek M, Teodorescu V, Falk A, Vassalotti JA, Uribarri J. Hemodialysis access placement with preoperative noninvasive vascular mapping: comparison between patients with and without diabetes. Am J Kidney Dis Off J Natl Kidney Found. 2001;38:560–4.

    Article  CAS  Google Scholar 

  31. Smith GE, Gohil R, Chetter IC. Factors affecting the patency of arteriovenous fistulas for dialysis access. J Vasc Surg. 2012;55:849–55.

    Article  PubMed  Google Scholar 

  32. Maeda K, Furukawa A, Yamasaki M, Murata K. Percutaneous transluminal angioplasty for Brescia–Cimino hemodialysis fistula dysfunction: technical success rate, patency rate and factors that influence the results. Eur J Radiol. 2005;54:426–30.

    Article  PubMed  Google Scholar 

  33. Heye S, Maleux G, Vaninbroukx J, Claes K, Kuypers D, Oyen R. Factors influencing technical success and outcome of percutaneous balloon angioplasty in de novo native hemodialysis arteriovenous fistulas. Eur J Radiol. 2012;81:2298–303.

    Article  PubMed  Google Scholar 

  34. Turmel-Rodrigues L, Pengloan J, Blanchier D, et al. Insufficient dialysis shunts: improved long-term patency rates with close hemodynamic monitoring, repeated percutaneous balloon angioplasty, and stent placement. Radiology. 1993;187:273–8.

    Article  CAS  PubMed  Google Scholar 

  35. Clark TWI, Hirsch DA, Jindal KJ, et al. Outcome and prognostic factors of restenosis after percutaneous treatment of native hemodialysis fistulas. J Vasc Interv Radiol. 2002;13:51–9.

    Article  PubMed  Google Scholar 

  36. Neuen BL, Gunnarsson R, Webster AC, Baer RA, Golledge J, Mantha ML. Predictors of patency after balloon angioplasty in hemodialysis fistulas: a systematic review. J Vasc Interv Radiol. 2014;25:917–24.

    Article  PubMed  Google Scholar 

  37. Lazarides MK, Georgiadis GS, Antoniou GA, Staramos DN. A metaanalysis of dialysis access outcome in elderly patients. J Vasc Surg. 2007;45:420–6.

    Article  PubMed  Google Scholar 

  38. Bountouris I, Kristmundsson T, Dias N, Zdanowski Z, Malina M. Is repeat PTA of a failing hemodialysis fistula durable? Int J Vasc Med. 2014;2014:369687.

    PubMed  PubMed Central  Google Scholar 

  39. Malka KT, Flahive J, Csizinscky A, et al. Results of repeated percutaneous interventions on failing arteriovenous fistulas and grafts and factors affecting outcomes. J Vasc Surg. 2016;63:772–7.

    Article  PubMed  Google Scholar 

  40. Massmann A, Fries P, Obst-Gleditsch K, et al. Paclitaxel-coated balloon angioplasty for symptomatic central vein restenosis in patients with hemodialysis fistulas. J Endovasc Ther. 2015;22:74–9.

    Article  PubMed  Google Scholar 

  41. 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. 2018:1129729818801556. https://doi.org/10.1177/1129729818801556. [Epub ahead of print].

  42. 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. 2018:1457496918798206. https://doi.org/10.1177/1457496918798206. [Epub ahead of print].

  43. 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. Italian J Vasc Endovasc Surg. 2017;24:35–40.

    Google Scholar 

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  1. Department of Radiology, Acibadem University Atakent Hospital, Turgut Ozal Str. No:16 Kucukcekmece, Istanbul, Turkey

    Isil Yildiz

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Correspondence to Isil Yildiz.

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While the present study was exempt from the requirement of ethical approval in relation to its retrospective design, the permission was obtained from our institutional ethics committee for the use of patient data for publication purposes.

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Yildiz, I. The Efficacy of Paclitaxel Drug-Eluting Balloon Angioplasty Versus Standard Balloon Angioplasty in Stenosis of Native Hemodialysis Arteriovenous Fistulas: An Analysis of Clinical Success, Primary Patency and Risk Factors for Recurrent Dysfunction. Cardiovasc Intervent Radiol 42, 685–692 (2019). https://doi.org/10.1007/s00270-019-02171-3

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