Efficacy of Paclitaxel Balloon for Hemodialysis Stenosis Fistulae After One Year Compared to High-Pressure Balloons: A Controlled, Multicenter, Randomized Trial
A controlled, prospective, multicenter, randomized trial to compare primary patency after angioplasty with a drug-coated balloon versus plain angioplasty balloon in stenosis of dysfunctional fistulae and grafts for hemodialysis.
Materials and Methods
A total of 136 patients (148 angioplasties) at four centers were randomized to receive a drug-coated balloon or plain angioplasty balloon after satisfactory angioplasty with a high-pressure balloon. The inclusion criteria were clinical signs of vascular dysfunction confirmed by Doppler Ultrasound and/or angiography. The primary endpoint was target lesion patency defined as time elapsed between the completion of effective and the appearance of restenosis at 6 and 12 months after angioplasty. Secondary endpoints included the relationship between the location of the stenosis, previous angioplasty, demographic variables and survival.
Primary patency after angioplasty was higher in the group treated with the drug-coated balloon than the plain angioplasty balloon (153.01 to 141.69 days at 6 months; 265.78 to 237.83 days at 12 months). Drug-coated balloon angioplasty resulted in superior patency after 6 and 12 months, but this result was not statically significant (P = 0.068 at 6 months; P = 0.369 at 12 months). There was no relation between target lesion patency and the other variables studied. Overall mortality in the plain angioplasty balloon group was higher (9% vs. 5.7%) but not statistically significant.
Drug-coated balloon angioplasty resulted in superior survival of dysfunctional peripheral vascular access at 6 and 12 months, but this result was not statistically significant. Both arms show equivalent complications and similar mortality.
Level of Evidence
Level Ia, therapeutic study, RCT. EBM ratings will be based on a scale of 1-5.
KeywordsPaclitaxel Drug-eluting balloon Angioplasty High-pressure balloon Hemodialysis Arteriovenous fistula Primary patency
Authors wish to thank the nephrologists Benitez M, Calurano R, Sánchez M, Martínez A and Torres MJ, the help in the follow-up of the patients participating in the study and the Regional Institute for Health and Clinical Research in Andalusia (Spain) for their support in the coordination and monitoring of this study.
Study conception and design were performed by TM-S and MM-R. Material preparation and data collection were performed by TM-S, MM-R, PP, PN and JG-R. Statistical analysis and results were performed by FHM. The first draft of the manuscript was written by TM-S and MM-R, and all authors commented on all versions of the manuscript. All authors read and approved the final manuscript.
“This study was funded by a grant from Biotronik SE & Co. KG, Berlin, Germany to the value of 14,838 € (Grant Number “Ref.2015 CEM BIOTRONIK S.A./FABIS 01”).” This Grant was donated to Fabis, the Foundation for Health Investigation in the Province of Huelva. Fabis is the manager and the administrator of the grant.
Compliance with Ethical Standards
Conflict of interest
The first author has received inscription to two courses: by Abbot (CLIC 2019) and by COOK (venous interventional course in 2018). The second author has received a grant by Bard to attend CIRSE 2018. The fourth author has received a speaker honorarium from Penumbra and from Boston Scientific in the last year
The trial took place in accordance with recommendations for clinical trials and product assessment in the research phase in the humans, which appears in The Declaration of Helsinki and revised at successive world assemblies (WMA, 2013) and current Spanish legislation on clinical trials (RD 223/2004). ICH-GCP (CPMP/ICH/135/95) rules were adhered to the CEIC (Ethical Committees) of the four hospitals, and the Regional Institute for Health and Clinical Research in Andalusia, Spain (RIHCRA), reviewed and approved the protocol and the signed consent form before recruiting began. Before carrying out any specific procedure in the protocol, the participant signed and dated the informed consent form approved by the CEIC. Monitoring and promotion were carried out by the RIHCRA as well as the coordination of the four centers. Consent for publication was obtained for every individual person’s data included in the study.
- 8.Katsanos K, Spiliopoulos S, Paraskevopoulos I, Diamantopoulos A, Karnabatidis D. Systematic review and meta-analysis of randomized controlled trials of paclitaxel-coated balloon angioplasty in the femoropopliteal arteries: role of paclitaxel dose and bioavailability. J Endovasc Ther. 2016;23(2):356–70. https://doi.org/10.1177/1526602815626557.CrossRefPubMedGoogle Scholar
- 9.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 Cardiovasc Interv. 2014;7(1):10–9.CrossRefGoogle Scholar
- 12.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(3):348–54.CrossRefGoogle Scholar
- 13.Teo T, Tan BS, Yin W, Lo R, Irani FG, Choong HS, et al. Prospective randomized trial comparing drug-eluting balloon versus conventional percutaneous transluminal angioplasty (DEBAPTA) for the treatment of hemodialysis arteriovenous fistula or arteriovenous graft stenoses—interim report of first 30 patients. J Vasc Interv Radiol. 2013;24(4):S40–1.CrossRefGoogle Scholar
- 14.Swinnen JJ, Hitos K, Kairaitis L, Gruenewald S, Larcos G, Farlow D, et al. Multicentre, randomised, blinded, control trial of drug-eluting balloon vs Sham in recurrent native dialysis fistula stenoses. J Vasc Access. 2018;20(3):260–9. https://doi.org/10.1177/1129729818801556.CrossRefPubMedGoogle Scholar
- 18.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.CrossRefGoogle Scholar
- 21.Besarab A, Ayyoub F. Anemia in renal disease. In: Schrier RW, editor. Diseases of the kidney and urinary tract. 8th ed. Philadelphia: Lippincott Williams and Wilkins; 2007. p. 2406–30.Google Scholar
- 25.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. JACC Cardiovasc Interv. 2016;9(13):1386–92.CrossRefGoogle Scholar
- 30.Hongsakul K, Bannangkoon K, Rookkapan S, Boonsrirat U, Kritpracha B, et al. Paclitaxel-coated balloon angioplasty for early restenosis of central veins in hemodialysis patients: a single center initial experience. Korean J Radiol. 2018;19(3):410–6. https://doi.org/10.3348/kjr.2018.19.3.410.CrossRefPubMedPubMedCentralGoogle Scholar
- 31.Gulcu A, Sarioglu O, Peker AAO, 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 Interv Radiol. 2019;42(6):835–40. https://doi.org/10.1007/s00270-019-02213-w.CrossRefGoogle Scholar
- 33.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(4):535–41. https://doi.org/10.1016/j.jvir.2013.12.014.CrossRefPubMedGoogle Scholar
- 35.Gongora CA, Shibuya M, Wessler JD, McGregor J, Tellez A, Cheng Y, Conditt GB, Kaluza GLGJ. Impact of paclitaxel dose on tissue pharmacokinetics and vascular healing: a comparative drug-coated balloon study in the familial hypercholesterolemic swine model of superficial femoral in-stent restenosis. JACC Cardiovasc Interv. 2015;8:1115–23.CrossRefGoogle Scholar
- 37.Katsanos K, Spiliopoulos S, Kitrou P, Krokidis M, Karnabatidis D, Randomized M, et al. 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. https://doi.org/10.1161/JAHA.118.011245.CrossRefPubMedPubMedCentralGoogle Scholar