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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

Open ArchivePublished:August 19, 2021DOI:https://doi.org/10.1016/j.ejvs.2021.05.043

      Objective

      A systematic review and meta-analysis of randomised controlled trials (RCTs) was performed to determine the effectiveness and safety of drug coated balloon (DCB) angioplasty compared with uncoated plain balloon (PB) angioplasty in treating arteriovenous access stenosis.

      Methods

      MEDLINE, Embase, Scopus, and the Cochrane Central Register of Controlled Trials were searched for RCTs comparing paclitaxel coated DCB and PB angioplasty for arteriovenous access stenosis. The last date of the literature search was 31 December 2020. Risk of bias of the retrieved studies was assessed with the Cochrane Collaboration tool for assessing risk of bias (RoB 2.0). The random effects model was used to estimate the risk of loss of target lesion patency (six and 12 months) and circuit patency (six and 12 months). Procedure related adverse events and mortality rate were also compared. Patency results were pooled using the time to event meta-analytical method and the quality of evidence was assessed according to the GRADE approach.

      Results

      Sixteen eligible trials, including 1 682 lesions, were included in the quantitative analysis for the efficacy and safety of paclitaxel coated DCBs. DCBs were associated with a lower risk of loss of target lesion patency at six months (HR 0.53, 95% CI 0.42 – 0.66) and 12 months (HR 0.60, 95% CI 0.47 – 0.76), and were also associated with improved six and 12 month circuit patency. Overall quality of evidence was moderate to low. Procedural complications were rare, and the risk of death up to 12 months was similar between the two groups (OR 1.03, 95% CI 0.68 – 1.56).

      Conclusion

      Paclitaxel coated DCBs reduced the risk of loss of target lesion patency and circuit patency in arteriovenous access stenosis compared with PBs. Considering the heterogeneity of the included trials, there is a need to investigate optimal treatment regimens regarding drug dose and agent of the DCB and the treatment procedure.

      Keywords

      Previous literature on the efficacy of drug coated balloons for arteriovenous access stenosis has been controversial. A meta-analysis of RCTs was performed using time to event meta-analytical methods. The results demonstrate that drug coated balloon angioplasty has benefits over plain balloon angioplasty in terms of target lesion patency and circuit patency up to one year.

      Introduction

      Well functioning dialysis access is essential for patients with end stage renal disease. Arteriovenous fistulas (AVFs) and grafts (AVGs) are the access of choice for haemodialysis; however, their patency rates remain suboptimal.
      • Arhuidese I.J.
      • Orandi B.J.
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      • Malas M.
      Utilization, patency, and complications associated with vascular access for hemodialysis in the United States.
      ,
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      • Zhang J.C.
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      • et al.
      Patency rates of the arteriovenous fistula for hemodialysis: a systematic review and meta-analysis.
      Loss of AVF or AVG patency is most commonly caused by access stenosis related to neointimal hyperplasia.
      • Brahmbhatt A.
      • Remuzzi A.
      • Franzoni M.
      • Misra S.
      The molecular mechanisms of hemodialysis vascular access failure.
      ,
      • Roy-Chaudhury P.
      • Sukhatme V.P.
      • Cheung A.K.
      Hemodialysis vascular access dysfunction: a cellular and molecular viewpoint.
      Although balloon angioplasty is safe and effective in treating access stenosis, recurrent stenosis is common, necessitating multiple interventions.
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      • Csizinscky A.
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      • et al.
      Results of repeated percutaneous interventions on failing arteriovenous fistulas and grafts and factors affecting outcomes.
      To improve the durability of balloon angioplasty, several new devices, including cutting balloons, drug coated balloons (DCBs), stents, and stent grafts, have been introduced.
      • Kitrou P.
      • Spiliopoulos S.
      • Karnabatidis D.
      • Katsanos K.
      Cutting balloons, covered stents and paclitaxel-coated balloons for the treatment of dysfunctional dialysis access.
      In particular, DCBs have emerged as a promising strategy, delivering agents that inhibit neointimal hyperplasia. Based on the positive results in the coronary and femoropopliteal arterial beds, the effectiveness of paclitaxel eluting DCBs for arteriovenous access stenosis is being actively evaluated. However, the results of the studies on the effectiveness of DCBs have been conflicting. Moreover, the results of seven meta-analyses combining this available evidence are also inconclusive.
      • Kennedy S.A.
      • Mafeld S.
      • Baerlocher M.O.
      • Jaberi A.
      • Rajan D.K.
      Drug-coated balloon angioplasty in hemodialysis circuits: a systematic review and meta-analysis.
      • Yan Wee I.J.
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      • Lee Qingwei S.
      • Tan C.S.
      • Tang T.Y.
      • et al.
      A systematic review and meta-analysis of drug-coated balloon versus conventional balloon angioplasty for dialysis access stenosis.
      • 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.
      • Cao Z.
      • Li J.
      • Zhang T.
      • Zhao K.
      • Zhao J.
      • Yang Y.
      • et al.
      Comparative effectiveness of drug-coated balloon vs balloon angioplasty for the treatment of arteriovenous fistula stenosis: a meta-analysis.
      • Chen X.
      • Liu Y.
      • Wang J.
      • Zhao J.
      • Singh N.
      • Zhang W.W.
      A systematic review and meta-analysis of the risk of death and patency after application of paclitaxel-coated balloons in the hemodialysis access.
      • Liao M.T.
      • Chen M.K.
      • Hsieh M.Y.
      • Yeh N.L.
      • Chien K.L.
      • Lin C.C.
      • 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.
      • Yuan Y.
      • Cheng W.
      • Lu H.
      Drug-eluting balloon versus plain balloon angioplasty for the treatment of failing hemodialysis access: a systematic review and meta-analysis.
      Most of these meta-analyses have not included the additional results from two recent large randomised controlled trials (RCTs),
      • Trerotola S.O.
      • Saad T.F.
      • Roy-Chaudhury P.
      The Lutonix AV randomized trial of paclitaxel-coated balloons in arteriovenous fistula stenosis: 2-year results and subgroup analysis.
      ,
      • Lookstein R.A.
      • Haruguchi H.
      • Ouriel K.
      • Weinberg I.
      • Lei L.
      • Cihlar S.
      • et al.
      Drug-coated balloons for dysfunctional dialysis arteriovenous fistulas.
      and despite concerns regarding aggregating time to event outcomes,
      • Antoniou G.A.
      • Antoniou S.A.
      • Smith C.T.
      A guide on meta-analysis of time-to-event outcomes using aggregate data in vascular and endovascular surgery.
      the patency outcomes were addressed as dichotomous data.
      Therefore, a comprehensive systematic review and meta-analysis was performed, which included the recent RCTs, and used time to event meta-analytical methods to compare the efficacy and safety of DCB and PB angioplasty in treating arteriovenous access stenosis.

      Materials and methods

      This systematic review and meta-analysis were conducted according to the Cochrane Handbook for Systematic Reviews of Interventions (version 5.1.0) and reported complying with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement. The protocol for the current review was registered in PROSPERO (CRD42019121251).

      Literature search and study selection

      MEDLINE, Embase, Scopus, and the Cochrane Central Register of Controlled Trials were searched without language or publication period restrictions to identify relevant trials to address the following review question.
      • 1)
        Patients: Patients with arteriovenous haemodialysis access stenosis
      • 2)
        Intervention: Drug coated balloon
      • 3)
        Comparator: Plain balloon angioplasty
      • 4)
        Outcomes: Efficacy outcome including target lesion patency and circuit patency, safety outcome (procedure related adverse event)
      • 5)
        Study design: RCTs
      A detailed search strategy was developed using both free text words and Medical Subject Headings (Supplementary Table 1). To identify ongoing studies, ClinicalTrials.gov and the ISRCTN registry were also searched. Grey literature databases, including the Grey Literature Report and OpenGrey, were also searched. The last database search was done on 31 December 2020. Additionally, the reference lists of relevant studies were searched manually.
      Two researchers (AH and TP) independently selected eligible studies, and any disagreement was resolved by a panel discussion with a third member (SM) of the review team. In addition to the criteria described by the review question, trials with at least six months of follow up that evaluated the efficacy (target lesion patency or circuit patency) or safety (procedure related adverse events) as one of the primary outcomes, were included. As for the efficacy outcome, only those with a summary of time to event data in the form of either hazard ratio (HR) and 95% confidence intervals (CI), or Kaplan–Meier curves were included in the quantitative analysis.

      Primary and secondary outcomes

      The primary efficacy outcome of this meta-analysis was the loss of target lesion patency (TLP) at six months. The primary safety outcome was the development of procedure related adverse events. Secondary outcomes included risk of loss of TLP at 12 months, loss of circuit patency (CP) at six and 12 months, procedure related complications, and all cause mortality within the study period.

      Data extraction

      Using a predefined data extraction form, two independent reviewers (AH and TP) extracted data on the following variables: (1) study characteristics (study design, single centre/multicentre, year published, funding source, unit of allocation, duration of participation, inclusion criteria, exclusion criteria, randomisation process, blinding, intervention and control procedure in detail [including devices, device inflation time, additional procedures performed, and provider], and pre- and post-operative medication); (2) patient (number of patients, age, sex, and comorbidities) and lesion (type of access, location of the target lesion, history of previous angioplasty, and access age) characteristics; (3) outcome results (target lesion patency and circuit patency [summary of time to event data as HR and 95% CI]) and number of events (loss of TLP, loss of CP, and procedure related adverse events) in each group; and (4) details needed for quality assessment. Principal investigators were contacted for ambiguities and missing data.

      Quality assessment

      Two researchers independently assessed the individual studies included in the meta-analysis for risk of bias using the Cochrane Collaboration tool for assessing the risk of bias (RoB 2.0).
      • Sterne J.A.C.
      • Savović J.
      • Page M.J.
      • Elbers R.G.
      • Blencowe N.S.
      • Boutron I.
      • et al.
      RoB 2: a revised tool for assessing risk of bias in randomised trials.
      Disagreements in the extracted data were resolved by a panel discussion. The certainty of the results of the main analysis was assessed using the Grading, Recommendations, Assessment, Development, and Evaluation approach.,

      Improving GRADE ‘Summary of findings’ tables for Cochrane Reviews: Detailed guidance for the calculation of absolute effect from time-to-event data. Available at https://training.cochrane.org/resource/improving-grade-%E2%80%98summary-findings%E2%80%99-tables-cochrane-reviews-detailed-guidance-calculation. Updated 2020-08-07. [Accessed 7 August 2020].

      Statistical methods

      Dichotomous data were summarised as odds ratios (ORs) with 95% CIs using the Mantel-Haenszel method. For lesion or circuit patency, HRs and standard errors from time to event data were summarised using the generic inverse variance method. When HRs were not provided, the data were estimated from Kaplan–Meier curves.
      • Tierney J.F.
      • Stewart L.A.
      • Ghersi D.
      • Burdett S.
      • Sydes M.R.
      Practical methods for incorporating summary time-to-event data into meta-analysis.
      The random effects model was used for all outcomes because of the expected between study heterogeneity.
      The heterogeneity of the included studies was assessed using Cochrane’s Q and I2statistics. I2 values ranged from 0% to 100%, with < 25%, 25% – 49%, 50% – 74%, and 75% – 100% corresponding to low, moderate, high, and extreme heterogeneity, respectively. In the event of significant heterogeneity, the source of heterogeneity was sought through sensitivity analyses by excluding one study at a time. To explore the possible variability in treatment effect in a specific population, subgroup analyses were performed according to the following criteria: type of arteriovenous access (AVF or AVG), mean arteriovenous access age (> 2 years or < 2 years), and type of device.
      Assessment of publication bias through funnel plot and Egger regression test was planned, provided that more than 10 trials were included with respect to the primary outcome of interest. The p values were two tailed with statistical significance set at .050. Statistical analyses were performed with RevMan 5.3 (The Nordic Cochrane Centre, Copenhagen, Denmark) and CMA 3.0 (Biostat, Inc., Englewood, NJ, USA).

      Results

      Literature search and study selection

      As shown in the PRISMA flow diagram (Fig. 1), 20 RCTs
      • Trerotola S.O.
      • Saad T.F.
      • Roy-Chaudhury P.
      The Lutonix AV randomized trial of paclitaxel-coated balloons in arteriovenous fistula stenosis: 2-year results and subgroup analysis.
      ,
      • Lookstein R.A.
      • Haruguchi H.
      • Ouriel K.
      • Weinberg I.
      • Lei L.
      • Cihlar S.
      • et al.
      Drug-coated balloons for dysfunctional dialysis arteriovenous fistulas.
      ,
      • 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).
      • Irani F.G.
      • Teo T.K.B.
      • Tay K.H.
      • Yin W.H.
      • Win H.H.
      • Gogna A.
      • et al.
      Hemodialysis arteriovenous fistula and graft stenoses: randomized trial comparing drug-eluting balloon angioplasty with conventional angioplasty.
      • Kitrou P.M.
      • 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).
      • Kitrou P.M.
      • Papadimatos P.
      • Spiliopoulos S.
      • Katsanos K.
      • Christeas N.
      • Brountzos E.
      • et al.
      Paclitaxel-coated balloons for the treatment of symptomatic central venous stenosis in dialysis access: results from a randomized controlled trial.
      • Kitrou P.M.
      • 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.
      • Liao M.T.
      • Lee C.P.
      • Lin T.T.
      • Jong C.B.
      • Chen T.Y.
      • Lin L.
      • et al.
      A randomized controlled trial of drug-coated balloon angioplasty in venous anastomotic stenosis of dialysis arteriovenous grafts.
      • Maleux G.
      • Vander Mijnsbrugge W.
      • Henroteaux D.
      • Laenen A.
      • Cornelissen S.
      • Claes K.
      • et al.
      Multicenter, randomized trial of conventional balloon angioplasty versus paclitaxel-coated balloon angioplasty for the treatment of dysfunctioning autologous dialysis fistulae.
      • Moreno-Sánchez T.
      • Moreno-Ramírez M.
      • Machancoses F.H.
      • Pardo-Moreno P.
      • Navarro-Vergara P.F.
      • García-Revillo J.
      Efficacy of paclitaxel balloon for hemodialysis stenosis fistulae after one year compared to high-pressure balloons: a controlled, multicenter, randomized trial.
      • Roosen L.J.
      • Karamermer Y.
      • Vos J.A.
      • de Jong G.M.
      • Bos W.J.
      • Elgersma O.E.
      Paclitaxel-coated balloons do not prevent recurrent stenosis in hemodialysis access fistulae: Results of a randomized clinical trial.
      • Swinnen J.J.
      • 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.
      • Fukasawa M.
      • Isobe M.
      • Nanto S.
      • Nakamura M.
      • Haruguchi H.
      • Miyake T.
      • et al.
      NF-κB decoy oligodeoxynucleotide-coated balloon catheter for arteriovenous fistula in hemodialysis.
      • Arabi M.
      • Salman R.
      • Bashir O.
      • Qazi S.
      • Alzahrani Y.
      • Farooqui M.
      • et al.
      4:03 PM Abstract No. 20 Paclitaxel coated balloons compared with plain balloon angioplasty in the management of dysfunctional arteriovenous fistulas: a single-institution randomized clinical trial.
      • Karmota A.G.
      Paclitaxel coated-balloon (PCB) versus standard plain old balloon (POB) fistuloplasty for failing dialysis access.
      • Kim J.W.
      • Kim J.H.
      • Byun S.S.
      • Kang J.M.
      • Shin J.H.
      Paclitaxel-coated balloon versus plain balloon angioplasty for dysfunctional autogenous radiocephalic arteriovenous fistulas: A prospective randomized controlled trial.
      • Pang S.Y.C.
      • Au-Yeung K.C.L.
      • Liu G.Y.L.
      • Tse R.O.H.
      • Lai D.
      • Leung W.K.W.
      • Mo K.L.
      • 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.
      • Rai A.
      • Amiri S.
      • Sobhiyeh M.
      The experience use of drug-coated and non drug-coated balloons in arteriovenous fistula at a six months period: brief report.
      • Therasse E.
      • Caty V.
      • Gilbert P.
      • Giroux M.F.
      • Perreault P.
      • Bouchard L.
      • et al.
      Safety and efficacy of paclitaxel-eluting balloon angioplasty for dysfunctional hemodialysis access: a randomized trial comparing with angioplasty alone.
      • Yin Y.
      • Shi Y.
      • Cui T.
      • Li H.
      • Chen J.
      • Zhang L.
      • et al.
      Efficacy and safety of paclitaxel-coated balloon angioplasty for dysfunctional arteriovenous fistulas: a multicenter randomized controlled trial.
      comparing DCB and PB angioplasty in haemodialysis arteriovenous access were identified. Two trials had published six month interim data separately.
      • 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.
      ,
      • Trerotola S.O.
      • Lawson J.
      • Roy-Chaudhury P.
      • Saad T.F.
      Drug coated balloon angioplasty in failing av fistulas: a randomized controlled trial.
      Figure 1
      Figure 1Preferred reporting items for systematic reviews and meta-analysis (PRISMA) flow diagram for the selection of randomised controlled trials (RCT) comparing paclitaxel coated balloon angioplasty and plain balloon angioplasty for haemodialysis arteriovenous access stenosis. DCB = drug coated balloon.
      Paclitaxel coated DCBs were investigated in 19 RCTs and one RCT
      • Fukasawa M.
      • Isobe M.
      • Nanto S.
      • Nakamura M.
      • Haruguchi H.
      • Miyake T.
      • et al.
      NF-κB decoy oligodeoxynucleotide-coated balloon catheter for arteriovenous fistula in hemodialysis.
      investigated NF-κB decoy oligodeoxynucleotide coated DCBs. Because of the substantial difference in the drug mechanism, a quantitative meta-analysis was performed only for the trials using paclitaxel coated DCBs. Among the retrieved trials, three RCTs were excluded because of insufficient data. RCTs by Karmota
      • Karmota A.G.
      Paclitaxel coated-balloon (PCB) versus standard plain old balloon (POB) fistuloplasty for failing dialysis access.
      and Arabi et al.
      • Arabi M.
      • Salman R.
      • Bashir O.
      • Qazi S.
      • Alzahrani Y.
      • Farooqui M.
      • et al.
      4:03 PM Abstract No. 20 Paclitaxel coated balloons compared with plain balloon angioplasty in the management of dysfunctional arteriovenous fistulas: a single-institution randomized clinical trial.
      were excluded from the evidence synthesis because of a lack of relevant time to event efficacy data and one year survival data. The RCT by Rai et al.
      • Rai A.
      • Amiri S.
      • Sobhiyeh M.
      The experience use of drug-coated and non drug-coated balloons in arteriovenous fistula at a six months period: brief report.
      was excluded because of limited information to assess its eligibility.
      The trial designs and methodologies are shown in Table 1. Eight multicentre trials
      • Trerotola S.O.
      • Saad T.F.
      • Roy-Chaudhury P.
      The Lutonix AV randomized trial of paclitaxel-coated balloons in arteriovenous fistula stenosis: 2-year results and subgroup analysis.
      ,
      • Lookstein R.A.
      • Haruguchi H.
      • Ouriel K.
      • Weinberg I.
      • Lei L.
      • Cihlar S.
      • et al.
      Drug-coated balloons for dysfunctional dialysis arteriovenous fistulas.
      ,
      • Maleux G.
      • Vander Mijnsbrugge W.
      • Henroteaux D.
      • Laenen A.
      • Cornelissen S.
      • Claes K.
      • et al.
      Multicenter, randomized trial of conventional balloon angioplasty versus paclitaxel-coated balloon angioplasty for the treatment of dysfunctioning autologous dialysis fistulae.
      • Moreno-Sánchez T.
      • Moreno-Ramírez M.
      • Machancoses F.H.
      • Pardo-Moreno P.
      • Navarro-Vergara P.F.
      • García-Revillo J.
      Efficacy of paclitaxel balloon for hemodialysis stenosis fistulae after one year compared to high-pressure balloons: a controlled, multicenter, randomized trial.
      • Roosen L.J.
      • Karamermer Y.
      • Vos J.A.
      • de Jong G.M.
      • Bos W.J.
      • Elgersma O.E.
      Paclitaxel-coated balloons do not prevent recurrent stenosis in hemodialysis access fistulae: Results of a randomized clinical trial.
      • Swinnen J.J.
      • 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.
      ,
      • Therasse E.
      • Caty V.
      • Gilbert P.
      • Giroux M.F.
      • Perreault P.
      • Bouchard L.
      • et al.
      Safety and efficacy of paclitaxel-eluting balloon angioplasty for dysfunctional hemodialysis access: a randomized trial comparing with angioplasty alone.
      ,
      • Yin Y.
      • Shi Y.
      • Cui T.
      • Li H.
      • Chen J.
      • Zhang L.
      • et al.
      Efficacy and safety of paclitaxel-coated balloon angioplasty for dysfunctional arteriovenous fistulas: a multicenter randomized controlled trial.
      were included, with the number of centres ranging from two to 29, and six had a core lab.
      • Lookstein R.A.
      • Haruguchi H.
      • Ouriel K.
      • Weinberg I.
      • Lei L.
      • Cihlar S.
      • et al.
      Drug-coated balloons for dysfunctional dialysis arteriovenous fistulas.
      ,
      • Maleux G.
      • Vander Mijnsbrugge W.
      • Henroteaux D.
      • Laenen A.
      • Cornelissen S.
      • Claes K.
      • et al.
      Multicenter, randomized trial of conventional balloon angioplasty versus paclitaxel-coated balloon angioplasty for the treatment of dysfunctioning autologous dialysis fistulae.
      ,
      • Swinnen J.J.
      • 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.
      ,
      • Therasse E.
      • Caty V.
      • Gilbert P.
      • Giroux M.F.
      • Perreault P.
      • Bouchard L.
      • et al.
      Safety and efficacy of paclitaxel-eluting balloon angioplasty for dysfunctional hemodialysis access: a randomized trial comparing with angioplasty alone.
      ,
      • Yin Y.
      • Shi Y.
      • Cui T.
      • Li H.
      • Chen J.
      • Zhang L.
      • et al.
      Efficacy and safety of paclitaxel-coated balloon angioplasty for dysfunctional arteriovenous fistulas: a multicenter randomized controlled trial.
      ,
      • Trerotola S.O.
      • Lawson J.
      • Roy-Chaudhury P.
      • Saad T.F.
      Drug coated balloon angioplasty in failing av fistulas: a randomized controlled trial.
      All but one trial
      • Maleux G.
      • Vander Mijnsbrugge W.
      • Henroteaux D.
      • Laenen A.
      • Cornelissen S.
      • Claes K.
      • et al.
      Multicenter, randomized trial of conventional balloon angioplasty versus paclitaxel-coated balloon angioplasty for the treatment of dysfunctioning autologous dialysis fistulae.
      reported patency results as the primary or secondary outcome. Six trials
      • Trerotola S.O.
      • Saad T.F.
      • Roy-Chaudhury P.
      The Lutonix AV randomized trial of paclitaxel-coated balloons in arteriovenous fistula stenosis: 2-year results and subgroup analysis.
      ,
      • Lookstein R.A.
      • Haruguchi H.
      • Ouriel K.
      • Weinberg I.
      • Lei L.
      • Cihlar S.
      • et al.
      Drug-coated balloons for dysfunctional dialysis arteriovenous fistulas.
      ,
      • Moreno-Sánchez T.
      • Moreno-Ramírez M.
      • Machancoses F.H.
      • Pardo-Moreno P.
      • Navarro-Vergara P.F.
      • García-Revillo J.
      Efficacy of paclitaxel balloon for hemodialysis stenosis fistulae after one year compared to high-pressure balloons: a controlled, multicenter, randomized trial.
      ,
      • Swinnen J.J.
      • 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.
      ,
      • Therasse E.
      • Caty V.
      • Gilbert P.
      • Giroux M.F.
      • Perreault P.
      • Bouchard L.
      • et al.
      Safety and efficacy of paclitaxel-eluting balloon angioplasty for dysfunctional hemodialysis access: a randomized trial comparing with angioplasty alone.
      ,
      • Yin Y.
      • Shi Y.
      • Cui T.
      • Li H.
      • Chen J.
      • Zhang L.
      • et al.
      Efficacy and safety of paclitaxel-coated balloon angioplasty for dysfunctional arteriovenous fistulas: a multicenter randomized controlled trial.
      (1 176/1 682 lesions) were sponsored by the manufacturers of the DCBs being studied.
      Table 1Characteristics of the 16 randomised controlled trials included in the systematic review on the efficacy and safety of paclitaxel coated balloon angioplasty for haemodialysis arteriovenous access stenosis compared with plain balloon angioplasty
      StudyCentres – nRegionIdentification numberFundingEnrolment timeMax. available follow up – moPrimary endpoint
      Björkman, 2019
      • 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).
      1FinlandNCT0303624108/2012 – 02/20161212 mo TLR
      Irani, 2018
      • Irani F.G.
      • Teo T.K.B.
      • Tay K.H.
      • Yin W.H.
      • Win H.H.
      • Gogna A.
      • et al.
      Hemodialysis arteriovenous fistula and graft stenoses: randomized trial comparing drug-eluting balloon angioplasty with conventional angioplasty.
      1SingaporeNCT01544907National research grant01/2012 – 03/2013126 mo TLPP
      Kim, 2020
      • Kim J.W.
      • Kim J.H.
      • Byun S.S.
      • Kang J.M.
      • Shin J.H.
      Paclitaxel-coated balloon versus plain balloon angioplasty for dysfunctional autogenous radiocephalic arteriovenous fistulas: A prospective randomized controlled trial.
      1KoreaKCT0004870Dong Kook Lifescience Co.
      Industry unrelated to the devices tested in the trial.
      06/2016 – 06/201836
      Not all patients followed up to 36 months. Follow ups were mandatory only up to the first reintervention event of the target lesion.
      6 (60)
      Not all patients followed up to 36 months. Follow ups were mandatory only up to the first reintervention event of the target lesion.
      Kitrou, 2015a
      • Kitrou P.M.
      • 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.
      1Greece03/2011 – 09/20121212 mo TLPP
      Kitrou, 2015b
      • Kitrou P.M.
      • 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).
      1GreeceNCT0117447203/2010 – 12/201012
      Six month interim reports published separately.
      TLR free interval
      Kitrou, 2017
      • Kitrou P.M.
      • Papadimatos P.
      • Spiliopoulos S.
      • Katsanos K.
      • Christeas N.
      • Brountzos E.
      • et al.
      Paclitaxel-coated balloons for the treatment of symptomatic central venous stenosis in dialysis access: results from a randomized controlled trial.
      1Greece01/2014 – 08/20156TLR free interval
      Liao, 2020
      • Liao M.T.
      • Lee C.P.
      • Lin T.T.
      • Jong C.B.
      • Chen T.Y.
      • Lin L.
      • et al.
      A randomized controlled trial of drug-coated balloon angioplasty in venous anastomotic stenosis of dialysis arteriovenous grafts.
      1TaiwanNCT03388892National research grant and institutional grant07/2015 – 08/2017126 mo TLPP
      Lookstein, 2020
      • Lookstein R.A.
      • Haruguchi H.
      • Ouriel K.
      • Weinberg I.
      • Lei L.
      • Cihlar S.
      • et al.
      Drug-coated balloons for dysfunctional dialysis arteriovenous fistulas.
      29US, Japan, NZNCT03041467Medtronic
      Manufacturing industries of drug coated balloon used in the trial.
      04/2017 – 05/20186
      Six month interim reports published separately.


      (24, 60
      Six month result published, and the study is currently ongoing. Planned length of follow up is 60 months.
      )
      6 mo TLPP
      Maleux, 2018
      • Maleux G.
      • Vander Mijnsbrugge W.
      • Henroteaux D.
      • Laenen A.
      • Cornelissen S.
      • Claes K.
      • et al.
      Multicenter, randomized trial of conventional balloon angioplasty versus paclitaxel-coated balloon angioplasty for the treatment of dysfunctioning autologous dialysis fistulae.
      3Belgium01/2013 – 10/2015123 mo / 6 mo / 12 mo CPP
      Moreno-Sánchez, 2020
      • Moreno-Sánchez T.
      • Moreno-Ramírez M.
      • Machancoses F.H.
      • Pardo-Moreno P.
      • Navarro-Vergara P.F.
      • García-Revillo J.
      Efficacy of paclitaxel balloon for hemodialysis stenosis fistulae after one year compared to high-pressure balloons: a controlled, multicenter, randomized trial.
      4SpainBiotrink
      Manufacturing industries of drug coated balloon used in the trial.
      01/2016 – 07/2017126 and 12 mo TLPP
      Pang, 2021
      • Pang S.Y.C.
      • Au-Yeung K.C.L.
      • Liu G.Y.L.
      • Tse R.O.H.
      • Lai D.
      • Leung W.K.W.
      • Mo K.L.
      • 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.
      1Hong KongANZCTR1261600078946006/2016 – 04/20181212 mo TLPP
      Roosen, 2017
      • Roosen L.J.
      • Karamermer Y.
      • Vos J.A.
      • de Jong G.M.
      • Bos W.J.
      • Elgersma O.E.
      Paclitaxel-coated balloons do not prevent recurrent stenosis in hemodialysis access fistulae: Results of a randomized clinical trial.
      2NetherlandsN/S24TLR free interval
      Swinnen, 2019
      • Swinnen J.J.
      • 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.
      3AustraliaACTRN12618001092280Medtronic
      Manufacturing industries of drug coated balloon used in the trial.
      01/2015 – 03/2017123 w / 3 mo / 6 mo / 12 mo LLL
      Therasse, 2021
      • Therasse E.
      • Caty V.
      • Gilbert P.
      • Giroux M.F.
      • Perreault P.
      • Bouchard L.
      • et al.
      Safety and efficacy of paclitaxel-eluting balloon angioplasty for dysfunctional hemodialysis access: a randomized trial comparing with angioplasty alone.
      3CanadaNCT01928498Biotronik
      Manufacturing industries of drug coated balloon used in the trial.
      03/2014 – 04/2018126 mo LLL
      Trerotola, 2020
      • Trerotola S.O.
      • Saad T.F.
      • Roy-Chaudhury P.
      The Lutonix AV randomized trial of paclitaxel-coated balloons in arteriovenous fistula stenosis: 2-year results and subgroup analysis.
      23USNCT02440022Bard
      Manufacturing industries of drug coated balloon used in the trial.
      06/2015 – 03/201624
      Six month interim reports published separately.
      6 mo TLPP
      Yin, 2021
      • Yin Y.
      • Shi Y.
      • Cui T.
      • Li H.
      • Chen J.
      • Zhang L.
      • et al.
      Efficacy and safety of paclitaxel-coated balloon angioplasty for dysfunctional arteriovenous fistulas: a multicenter randomized controlled trial.
      10ChinaNCT02962141Cardionovum
      Manufacturing industries of drug coated balloon used in the trial.
      11/2016 – 07/2017126 mo TLPP
      TLR = target lesion revascularisation; TLPP = target lesion primary patency; CPP = circuit primary patency; LLL = late lumen loss; N/S = not specified.
      Industry unrelated to the devices tested in the trial.
      Not all patients followed up to 36 months. Follow ups were mandatory only up to the first reintervention event of the target lesion.
      Six month interim reports published separately.
      § Six month result published, and the study is currently ongoing. Planned length of follow up is 60 months.
      Manufacturing industries of drug coated balloon used in the trial.

      Trial level characteristics of interventions and populations

      The 16 included studies involved 1 682 stenotic lesions (844 in the DCB group and 838 in the PB group). The patient and lesion characteristics are provided in Table 2. AVF with native vein was the most common type of access; only 128 lesions used AVG. Although one trial included central vein lesions exclusively,
      • Kitrou P.M.
      • Papadimatos P.
      • Spiliopoulos S.
      • Katsanos K.
      • Christeas N.
      • Brountzos E.
      • et al.
      Paclitaxel-coated balloons for the treatment of symptomatic central venous stenosis in dialysis access: results from a randomized controlled trial.
      in nine trials,
      • Trerotola S.O.
      • Saad T.F.
      • Roy-Chaudhury P.
      The Lutonix AV randomized trial of paclitaxel-coated balloons in arteriovenous fistula stenosis: 2-year results and subgroup analysis.
      ,
      • Lookstein R.A.
      • Haruguchi H.
      • Ouriel K.
      • Weinberg I.
      • Lei L.
      • Cihlar S.
      • et al.
      Drug-coated balloons for dysfunctional dialysis arteriovenous fistulas.
      ,
      • Kitrou P.M.
      • 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).
      ,
      • Kitrou P.M.
      • 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.
      ,
      • Maleux G.
      • Vander Mijnsbrugge W.
      • Henroteaux D.
      • Laenen A.
      • Cornelissen S.
      • Claes K.
      • et al.
      Multicenter, randomized trial of conventional balloon angioplasty versus paclitaxel-coated balloon angioplasty for the treatment of dysfunctioning autologous dialysis fistulae.
      ,
      • Swinnen J.J.
      • 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.
      ,
      • Kim J.W.
      • Kim J.H.
      • Byun S.S.
      • Kang J.M.
      • Shin J.H.
      Paclitaxel-coated balloon versus plain balloon angioplasty for dysfunctional autogenous radiocephalic arteriovenous fistulas: A prospective randomized controlled trial.
      ,
      • Pang S.Y.C.
      • Au-Yeung K.C.L.
      • Liu G.Y.L.
      • Tse R.O.H.
      • Lai D.
      • Leung W.K.W.
      • Mo K.L.
      • 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.
      ,
      • Yin Y.
      • Shi Y.
      • Cui T.
      • Li H.
      • Chen J.
      • Zhang L.
      • et al.
      Efficacy and safety of paclitaxel-coated balloon angioplasty for dysfunctional arteriovenous fistulas: a multicenter randomized controlled trial.
      stenoses of the central vein were excluded (Supplementary Table 3). The mean age of the fistula included in the majority of the trials was > 2 years (Table 2).
      • Trerotola S.O.
      • Saad T.F.
      • Roy-Chaudhury P.
      The Lutonix AV randomized trial of paclitaxel-coated balloons in arteriovenous fistula stenosis: 2-year results and subgroup analysis.
      ,
      • Lookstein R.A.
      • Haruguchi H.
      • Ouriel K.
      • Weinberg I.
      • Lei L.
      • Cihlar S.
      • et al.
      Drug-coated balloons for dysfunctional dialysis arteriovenous fistulas.
      ,
      • Irani F.G.
      • Teo T.K.B.
      • Tay K.H.
      • Yin W.H.
      • Win H.H.
      • Gogna A.
      • et al.
      Hemodialysis arteriovenous fistula and graft stenoses: randomized trial comparing drug-eluting balloon angioplasty with conventional angioplasty.
      • Kitrou P.M.
      • 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).
      • Kitrou P.M.
      • Papadimatos P.
      • Spiliopoulos S.
      • Katsanos K.
      • Christeas N.
      • Brountzos E.
      • et al.
      Paclitaxel-coated balloons for the treatment of symptomatic central venous stenosis in dialysis access: results from a randomized controlled trial.
      • Kitrou P.M.
      • 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.
      • Liao M.T.
      • Lee C.P.
      • Lin T.T.
      • Jong C.B.
      • Chen T.Y.
      • Lin L.
      • et al.
      A randomized controlled trial of drug-coated balloon angioplasty in venous anastomotic stenosis of dialysis arteriovenous grafts.
      • Maleux G.
      • Vander Mijnsbrugge W.
      • Henroteaux D.
      • Laenen A.
      • Cornelissen S.
      • Claes K.
      • et al.
      Multicenter, randomized trial of conventional balloon angioplasty versus paclitaxel-coated balloon angioplasty for the treatment of dysfunctioning autologous dialysis fistulae.
      ,
      • Pang S.Y.C.
      • Au-Yeung K.C.L.
      • Liu G.Y.L.
      • Tse R.O.H.
      • Lai D.
      • Leung W.K.W.
      • Mo K.L.
      • 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.
      ,
      • Therasse E.
      • Caty V.
      • Gilbert P.
      • Giroux M.F.
      • Perreault P.
      • Bouchard L.
      • et al.
      Safety and efficacy of paclitaxel-eluting balloon angioplasty for dysfunctional hemodialysis access: a randomized trial comparing with angioplasty alone.
      The proportion of lesions with recurrent stenosis varied across trials.
      Table 2Participant and lesion characteristics of the 16 randomised controlled trials included in the systematic review on the efficacy and safety of paclitaxel coated balloon (DCB) angioplasty for haemodialysis arteriovenous access stenosis compared with plain balloon (PB) angioplasty
      StudyParticipant characteristicsFistula/lesion characteristics
      Patients DCB:PB (total) – nMean age DCB vs. PB – yMalesDMAVGMean fistula age DCB vs. PB – yPrevious intervention DCB vs. PBCV lesion DCB vs. PBMean lesion length DCB vs. PB – cm
      Björkman, 201921
      Values for the characteristics of Bjorkman et al., Irani et al., and Kim et al. were based on analysed population – 36 (DCB 18, PB 18) for Bjorkman et al., 119 (DCB 59, PB 60) patients for Irani et al., and 39 (DCB 20, PB 19) for Kim et al.
      21:18 (39)67 vs. 67
      Median values.
      23 (63.9)22 (61.1)00.5 vs. 0.8
      Median values.
      N/S02.3 vs. 1.6
      Median values.
      Irani, 201822
      Values for the characteristics of Bjorkman et al., Irani et al., and Kim et al. were based on analysed population – 36 (DCB 18, PB 18) for Bjorkman et al., 119 (DCB 59, PB 60) patients for Irani et al., and 39 (DCB 20, PB 19) for Kim et al.
      63:62 (125)59 vs. 5979 (66.4)71 (60.0)21 (17.6)3.7 vs. 3.91.8 ± 2.3 vs. 2.1 ± 2.7
      Numbers of included patients with previous angioplasty of the access (in mean ± standard deviation and median [interquartile range]). The previous angioplasty was not necessarily performed at the same index lesion for Irani et al., and the site of the previous angioplasty was not explicitly mentioned for Liao et al.
      10 (16.9) vs. 4 (6.7)2.6 vs. 2.5
      Median values.
      Kim, 202034
      Values for the characteristics of Bjorkman et al., Irani et al., and Kim et al. were based on analysed population – 36 (DCB 18, PB 18) for Bjorkman et al., 119 (DCB 59, PB 60) patients for Irani et al., and 39 (DCB 20, PB 19) for Kim et al.
      20:20 (40)61 vs. 6421 (53.8)35 (84.6)02.3 vs. 1.65 (25.0) vs. 3 (15.8)03.0 vs. 3.4
      Kitrou, 2015a
      • Kitrou P.M.
      • 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.
      20:20 (40)64 vs. 5726 (65.0)11 (27.5)
      The study did not provide the incidence of diabetes. The incidence of renal failure from diabetes is shown.
      02.1 vs. 2.7N/S0N/S
      Kitrou, 2015b
      • Kitrou P.M.
      • 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).
      20:20 (40)66 vs. 6329 (72.5)8 (20.0)
      The study did not provide the incidence of diabetes. The incidence of renal failure from diabetes is shown.
      26 (65.0)2.5 vs. 2.5N/S0N/S
      Kitrou, 2017
      • Kitrou P.M.
      • Papadimatos P.
      • Spiliopoulos S.
      • Katsanos K.
      • Christeas N.
      • Brountzos E.
      • et al.
      Paclitaxel-coated balloons for the treatment of symptomatic central venous stenosis in dialysis access: results from a randomized controlled trial.
      20:20 (40)57 vs. 57
      Median values.
      29 (72.5)24 (60.0)21 (52.5)2.8 vs. 2.4
      Median values.
      15 (75) vs. 12 (60)20 (100) vs. 20 (100)N/S
      Liao, 2020
      • Liao M.T.
      • Lee C.P.
      • Lin T.T.
      • Jong C.B.
      • Chen T.Y.
      • Lin L.
      • et al.
      A randomized controlled trial of drug-coated balloon angioplasty in venous anastomotic stenosis of dialysis arteriovenous grafts.
      22:22 (44)70 vs. 6612 (27.3) j29 (65.9)44 (100)2.3 vs. 2.8
      Median values.
      3 [1–6] vs. 3 [1–12]
      Numbers of included patients with previous angioplasty of the access (in mean ± standard deviation and median [interquartile range]). The previous angioplasty was not necessarily performed at the same index lesion for Irani et al., and the site of the previous angioplasty was not explicitly mentioned for Liao et al.
      03.6 vs. 3.4
      Lookstein, 2020
      • Lookstein R.A.
      • Haruguchi H.
      • Ouriel K.
      • Weinberg I.
      • Lei L.
      • Cihlar S.
      • et al.
      Drug-coated balloons for dysfunctional dialysis arteriovenous fistulas.
      170:160 (330)66 vs. 66213 (64.5)217 (65.8)03.2 vs. 3.5119 (70.0) vs. 111 (69.4)
      Median values.
      04.6 vs. 4.2
      Maleux, 2018
      • Maleux G.
      • Vander Mijnsbrugge W.
      • Henroteaux D.
      • Laenen A.
      • Cornelissen S.
      • Claes K.
      • et al.
      Multicenter, randomized trial of conventional balloon angioplasty versus paclitaxel-coated balloon angioplasty for the treatment of dysfunctioning autologous dialysis fistulae.
      33:31 (64)69 vs. 6742 (65.6)N/S03.9 vs. 2.918 (54.5) vs. 19 (58.3)0N/S
      Moreno-Sánchez, 2020
      • Moreno-Sánchez T.
      • Moreno-Ramírez M.
      • Machancoses F.H.
      • Pardo-Moreno P.
      • Navarro-Vergara P.F.
      • García-Revillo J.
      Efficacy of paclitaxel balloon for hemodialysis stenosis fistulae after one year compared to high-pressure balloons: a controlled, multicenter, randomized trial.
      70:78 (148)
      Numbers of lesions.
      69 vs. 71
      Numbers of lesions.
      107 (72.3)
      Numbers of lesions.
      38 (25.7)
      The study did not provide the incidence of diabetes. The incidence of renal failure from diabetes is shown.
      ,
      Numbers of lesions.
      12 (8.1)N/S29 (41.4) vs. 27 (34.6)
      Numbers of lesions.
      0N/S
      Pang, 2021
      • Pang S.Y.C.
      • Au-Yeung K.C.L.
      • Liu G.Y.L.
      • Tse R.O.H.
      • Lai D.
      • Leung W.K.W.
      • Mo K.L.
      • 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.
      20:20 (40)58 vs. 5732 (80.0)10 (25.0)12 (30.0)2.4 vs. 2.216 (80.0) vs. 14 (70.0)04.6 vs.5.0
      Roosen, 2017
      • Roosen L.J.
      • Karamermer Y.
      • Vos J.A.
      • de Jong G.M.
      • Bos W.J.
      • Elgersma O.E.
      Paclitaxel-coated balloons do not prevent recurrent stenosis in hemodialysis access fistulae: Results of a randomized clinical trial.
      16:18 (34)80 vs. 83
      Median values.
      21 (61.8)10 (59.7)4 (11.8)N/S16 (100) vs. 18 (100)N/S3.0 vs. 2.0
      Median values.
      Swinnen, 2019
      • Swinnen J.J.
      • 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.
      70:62 (132)65 vs. 6479 (61.7)77 (60.1)0>0.5:

      97% vs. 95%
      22 immature fistulas included.
      70 (100) vs. 62 (100)0≤2:

      72% vs. 83%
      Therasse, 2021
      • Therasse E.
      • Caty V.
      • Gilbert P.
      • Giroux M.F.
      • Perreault P.
      • Bouchard L.
      • et al.
      Safety and efficacy of paclitaxel-eluting balloon angioplasty for dysfunctional hemodialysis access: a randomized trial comparing with angioplasty alone.
      60:60 (120)64 vs. 67100 (83.3)80 (66.7)11 (9.2)2.6 vs. 2.622 (35.6) vs. 21 (35.0)03.0 vs. 3.2
      Trerotola, 202014
      Three patients randomised to the plain PTA group were treated with DCB.
      141:144 (285)64 vs. 61172 (60.4)176 (61.8)03.2 vs. 2.9120 (85.1) vs. 125 (87)02.8 vs. 3.0
      Yin, 2021
      • Yin Y.
      • Shi Y.
      • Cui T.
      • Li H.
      • Chen J.
      • Zhang L.
      • et al.
      Efficacy and safety of paclitaxel-coated balloon angioplasty for dysfunctional arteriovenous fistulas: a multicenter randomized controlled trial.
      78:83 (161)56 vs. 5486 (53.4)56 (34.8)0N/S8 (10) vs. 9 (11)01.9 vs. 1.9
      Data are presented as n (%) unless stated otherwise. DCB = drug coated balloon; PB = plain balloon; CV = central vein; N/S = not specified; DM = diabetes mellitus; AVG = arteriovenous graft.
      Values for the characteristics of Bjorkman et al., Irani et al., and Kim et al. were based on analysed population – 36 (DCB 18, PB 18) for Bjorkman et al., 119 (DCB 59, PB 60) patients for Irani et al., and 39 (DCB 20, PB 19) for Kim et al.
      Median values.
      Numbers of included patients with previous angioplasty of the access (in mean ± standard deviation and median [interquartile range]). The previous angioplasty was not necessarily performed at the same index lesion for Irani et al., and the site of the previous angioplasty was not explicitly mentioned for Liao et al.
      § The study did not provide the incidence of diabetes. The incidence of renal failure from diabetes is shown.
      Numbers of lesions.
      22 immature fistulas included.
      ∗∗ Three patients randomised to the plain PTA group were treated with DCB.

      Procedural characteristics of the included randomised controlled trials

      Four different types of paclitaxel coated balloons were used: 11 trials used IN.PACT,
      • Lookstein R.A.
      • Haruguchi H.
      • Ouriel K.
      • Weinberg I.
      • Lei L.
      • Cihlar S.
      • et al.
      Drug-coated balloons for dysfunctional dialysis arteriovenous fistulas.
      ,
      • 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).
      • Irani F.G.
      • Teo T.K.B.
      • Tay K.H.
      • Yin W.H.
      • Win H.H.
      • Gogna A.
      • et al.
      Hemodialysis arteriovenous fistula and graft stenoses: randomized trial comparing drug-eluting balloon angioplasty with conventional angioplasty.
      • Kitrou P.M.
      • 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).
      ,
      • Kitrou P.M.
      • 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.
      • Liao M.T.
      • Lee C.P.
      • Lin T.T.
      • Jong C.B.
      • Chen T.Y.
      • Lin L.
      • et al.
      A randomized controlled trial of drug-coated balloon angioplasty in venous anastomotic stenosis of dialysis arteriovenous grafts.
      • Maleux G.
      • Vander Mijnsbrugge W.
      • Henroteaux D.
      • Laenen A.
      • Cornelissen S.
      • Claes K.
      • et al.
      Multicenter, randomized trial of conventional balloon angioplasty versus paclitaxel-coated balloon angioplasty for the treatment of dysfunctioning autologous dialysis fistulae.
      ,
      • Roosen L.J.
      • Karamermer Y.
      • Vos J.A.
      • de Jong G.M.
      • Bos W.J.
      • Elgersma O.E.
      Paclitaxel-coated balloons do not prevent recurrent stenosis in hemodialysis access fistulae: Results of a randomized clinical trial.
      ,
      • Swinnen J.J.
      • 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.
      ,
      • Kim J.W.
      • Kim J.H.
      • Byun S.S.
      • Kang J.M.
      • Shin J.H.
      Paclitaxel-coated balloon versus plain balloon angioplasty for dysfunctional autogenous radiocephalic arteriovenous fistulas: A prospective randomized controlled trial.
      ,
      • Pang S.Y.C.
      • Au-Yeung K.C.L.
      • Liu G.Y.L.
      • Tse R.O.H.
      • Lai D.
      • Leung W.K.W.
      • Mo K.L.
      • 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.
      Lutonix
      • Trerotola S.O.
      • Saad T.F.
      • Roy-Chaudhury P.
      The Lutonix AV randomized trial of paclitaxel-coated balloons in arteriovenous fistula stenosis: 2-year results and subgroup analysis.
      ,
      • Kitrou P.M.
      • Papadimatos P.
      • Spiliopoulos S.
      • Katsanos K.
      • Christeas N.
      • Brountzos E.
      • et al.
      Paclitaxel-coated balloons for the treatment of symptomatic central venous stenosis in dialysis access: results from a randomized controlled trial.
      and Passeo-18 Lux
      • Moreno-Sánchez T.
      • Moreno-Ramírez M.
      • Machancoses F.H.
      • Pardo-Moreno P.
      • Navarro-Vergara P.F.
      • García-Revillo J.
      Efficacy of paclitaxel balloon for hemodialysis stenosis fistulae after one year compared to high-pressure balloons: a controlled, multicenter, randomized trial.
      ,
      • Therasse E.
      • Caty V.
      • Gilbert P.
      • Giroux M.F.
      • Perreault P.
      • Bouchard L.
      • et al.
      Safety and efficacy of paclitaxel-eluting balloon angioplasty for dysfunctional hemodialysis access: a randomized trial comparing with angioplasty alone.
      were used by two trials each, and one trial used APERTO
      • Yin Y.
      • Shi Y.
      • Cui T.
      • Li H.
      • Chen J.
      • Zhang L.
      • et al.
      Efficacy and safety of paclitaxel-coated balloon angioplasty for dysfunctional arteriovenous fistulas: a multicenter randomized controlled trial.
      (Table 3). The trials had considerable differences regarding pre-ballooning, inflation time, procedure, and adjunctive procedures. In four trials, DCB angioplasty was performed without pre-dilation of the stenotic lesion,
      • Kitrou P.M.
      • 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).
      ,
      • Kitrou P.M.
      • Papadimatos P.
      • Spiliopoulos S.
      • Katsanos K.
      • Christeas N.
      • Brountzos E.
      • et al.
      Paclitaxel-coated balloons for the treatment of symptomatic central venous stenosis in dialysis access: results from a randomized controlled trial.
      ,
      • Liao M.T.
      • Lee C.P.
      • Lin T.T.
      • Jong C.B.
      • Chen T.Y.
      • Lin L.
      • et al.
      A randomized controlled trial of drug-coated balloon angioplasty in venous anastomotic stenosis of dialysis arteriovenous grafts.
      ,
      • Roosen L.J.
      • Karamermer Y.
      • Vos J.A.
      • de Jong G.M.
      • Bos W.J.
      • Elgersma O.E.
      Paclitaxel-coated balloons do not prevent recurrent stenosis in hemodialysis access fistulae: Results of a randomized clinical trial.
      whereas DCBs were used after vessel preparation using high pressure uncoated balloons in 11 trials.
      • Trerotola S.O.
      • Saad T.F.
      • Roy-Chaudhury P.
      The Lutonix AV randomized trial of paclitaxel-coated balloons in arteriovenous fistula stenosis: 2-year results and subgroup analysis.
      ,
      • Lookstein R.A.
      • Haruguchi H.
      • Ouriel K.
      • Weinberg I.
      • Lei L.
      • Cihlar S.
      • et al.
      Drug-coated balloons for dysfunctional dialysis arteriovenous fistulas.
      ,
      • 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).
      ,
      • Irani F.G.
      • Teo T.K.B.
      • Tay K.H.
      • Yin W.H.
      • Win H.H.
      • Gogna A.
      • et al.
      Hemodialysis arteriovenous fistula and graft stenoses: randomized trial comparing drug-eluting balloon angioplasty with conventional angioplasty.
      ,
      • Kitrou P.M.
      • Papadimatos P.
      • Spiliopoulos S.
      • Katsanos K.
      • Christeas N.
      • Brountzos E.
      • et al.
      Paclitaxel-coated balloons for the treatment of symptomatic central venous stenosis in dialysis access: results from a randomized controlled trial.
      ,
      • Maleux G.
      • Vander Mijnsbrugge W.
      • Henroteaux D.
      • Laenen A.
      • Cornelissen S.
      • Claes K.
      • et al.
      Multicenter, randomized trial of conventional balloon angioplasty versus paclitaxel-coated balloon angioplasty for the treatment of dysfunctioning autologous dialysis fistulae.
      ,
      • Moreno-Sánchez T.
      • Moreno-Ramírez M.
      • Machancoses F.H.
      • Pardo-Moreno P.
      • Navarro-Vergara P.F.
      • García-Revillo J.
      Efficacy of paclitaxel balloon for hemodialysis stenosis fistulae after one year compared to high-pressure balloons: a controlled, multicenter, randomized trial.
      ,
      • Swinnen J.J.
      • 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.
      ,
      • Kim J.W.
      • Kim J.H.
      • Byun S.S.
      • Kang J.M.
      • Shin J.H.
      Paclitaxel-coated balloon versus plain balloon angioplasty for dysfunctional autogenous radiocephalic arteriovenous fistulas: A prospective randomized controlled trial.
      ,
      • Therasse E.
      • Caty V.
      • Gilbert P.
      • Giroux M.F.
      • Perreault P.
      • Bouchard L.
      • et al.
      Safety and efficacy of paclitaxel-eluting balloon angioplasty for dysfunctional hemodialysis access: a randomized trial comparing with angioplasty alone.
      ,
      • Yin Y.
      • Shi Y.
      • Cui T.
      • Li H.
      • Chen J.
      • Zhang L.
      • et al.
      Efficacy and safety of paclitaxel-coated balloon angioplasty for dysfunctional arteriovenous fistulas: a multicenter randomized controlled trial.
      Of these, six trials
      • Trerotola S.O.
      • Saad T.F.
      • Roy-Chaudhury P.
      The Lutonix AV randomized trial of paclitaxel-coated balloons in arteriovenous fistula stenosis: 2-year results and subgroup analysis.
      ,
      • Lookstein R.A.
      • Haruguchi H.
      • Ouriel K.
      • Weinberg I.
      • Lei L.
      • Cihlar S.
      • et al.
      Drug-coated balloons for dysfunctional dialysis arteriovenous fistulas.
      ,
      • 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).
      ,
      • Moreno-Sánchez T.
      • Moreno-Ramírez M.
      • Machancoses F.H.
      • Pardo-Moreno P.
      • Navarro-Vergara P.F.
      • García-Revillo J.
      Efficacy of paclitaxel balloon for hemodialysis stenosis fistulae after one year compared to high-pressure balloons: a controlled, multicenter, randomized trial.
      ,
      • Swinnen J.J.
      • 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.
      ,
      • Therasse E.
      • Caty V.
      • Gilbert P.
      • Giroux M.F.
      • Perreault P.
      • Bouchard L.
      • et al.
      Safety and efficacy of paclitaxel-eluting balloon angioplasty for dysfunctional hemodialysis access: a randomized trial comparing with angioplasty alone.
      had patients enrolled and randomised to either the DCB or PB groups when successful pre-dilation was achieved.
      Table 3Procedural characteristics of the 16 randomised controlled trials included in the systematic review on the efficacy and safety of paclitaxel coated balloon (DCB) angioplasty for haemodialysis arteriovenous access stenosis compared with plain balloon (PB) angioplasty
      StudyIntervention procedureControl group procedureFollow up protocol
      DCB devicePre-ballooning before DCBDCB inflation pressureDCB inflation timeAdditional procedure after DCBPB deviceHeparin during procedurePost-operative anticoagulation
      Björkman, 2019
      • 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).
      IN.PACTUndersized

      plain balloon

      (no HPB)
      Patients were enrolled and randomised after successful vessel preparation (i.e., pre-ballooning) with an uncoated plain balloon or standard endovascular treatment.
      N/S90 secNoneUndersized plain balloon

      + uncoated balloon (no HPB)
      5000 IUDAPT
      ASA 100 mg + clopidogrel 75 mg or warfarin + ASA 50 mg if the patient was already receiving warfarin.
      US (1, 6, and 12 mo)
      Irani, 2018
      • Irani F.G.
      • Teo T.K.B.
      • Tay K.H.
      • Yin W.H.
      • Win H.H.
      • Gogna A.
      • et al.
      Hemodialysis arteriovenous fistula and graft stenoses: randomized trial comparing drug-eluting balloon angioplasty with conventional angioplasty.
      IN.PACT AdmiralHPB14 atm60 secNoneHPB2000 IUDAPT one mo,

      then ASA five mo
      Angiography (6 mo)
      Kim, 2020
      • Kim J.W.
      • Kim J.H.
      • Byun S.S.
      • Kang J.M.
      • Shin J.H.
      Paclitaxel-coated balloon versus plain balloon angioplasty for dysfunctional autogenous radiocephalic arteriovenous fistulas: A prospective randomized controlled trial.
      IN.PACT Admiral (4 mm or 5 mm)HPB (4 mm)14 atm120 secBA with HPB, cutting balloon in residual stenosisHPB2500 IUN/SClinical monitoring
      Kitrou, 2015a
      • Kitrou P.M.
      • 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.
      IN.PACT AdmiralNone12 atm90 secBA with HPB in residual stenosis
      17 of 20 patients in Kitrou 2015a and 11 of 20 patients in Kitrou 2015b needed balloon angioplasty with a high pressure balloon after angioplasty with DCB.
      HPB5000 IUASAClinical monitoring
      Kitrou, 2015b
      • Kitrou P.M.
      • 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).
      IN.PACTNone8 atm>60 secBA with HPB in residual stenosis
      17 of 20 patients in Kitrou 2015a and 11 of 20 patients in Kitrou 2015b needed balloon angioplasty with a high pressure balloon after angioplasty with DCB.
      HPB5000 IUClopidogrelAngiography (every 2 mo)

      Clinical monitoring
      Kitrou, 2017
      • Kitrou P.M.
      • Papadimatos P.
      • Spiliopoulos S.
      • Katsanos K.
      • Christeas N.
      • Brountzos E.
      • et al.
      Paclitaxel-coated balloons for the treatment of symptomatic central venous stenosis in dialysis access: results from a randomized controlled trial.
      LutonixHPB
      In cases of residual stenosis after angioplasty with a high pressure balloon (2 min), prolonged inflation (4 min) or angioplasty with a larger balloon was performed.
      N/S120 secNoneHPB
      In cases of residual stenosis after angioplasty with a high pressure balloon (2 min), prolonged inflation (4 min) or angioplasty with a larger balloon was performed.
      5000 IUN/SClinical monitoring
      Liao, 2020
      • Liao M.T.
      • Lee C.P.
      • Lin T.T.
      • Jong C.B.
      • Chen T.Y.
      • Lin L.
      • et al.
      A randomized controlled trial of drug-coated balloon angioplasty in venous anastomotic stenosis of dialysis arteriovenous grafts.
      IN. PACT AdmiralNoneN/SN/SPost-dilatation with HPBPlain balloon
      If a waist persisted after initial ballooning with a non-compliant high pressure balloon (Conquest).
      N/SASA, 3 d

      and as needed
      Angiography (every 2 mo)

      Clinical monitoring
      Lookstein, 2020
      • Lookstein R.A.
      • Haruguchi H.
      • Ouriel K.
      • Weinberg I.
      • Lei L.
      • Cihlar S.
      • et al.
      Drug-coated balloons for dysfunctional dialysis arteriovenous fistulas.
      IN. PACT

      AV Access
      HPB
      Patients were enrolled and randomised after successful vessel preparation (i.e., pre-ballooning) with an uncoated plain balloon or standard endovascular treatment.
      NP>180 secAdditional BA allowed

      (stenting avoided)
      HPB + uncoated balloonN/S≥1 APT 1 moUS (1, 6, and 12 mo)

      Clinical monitoring
      Maleux, 2018
      • Maleux G.
      • Vander Mijnsbrugge W.
      • Henroteaux D.
      • Laenen A.
      • Cornelissen S.
      • Claes K.
      • et al.
      Multicenter, randomized trial of conventional balloon angioplasty versus paclitaxel-coated balloon angioplasty for the treatment of dysfunctioning autologous dialysis fistulae.
      IN.PACT AdmiralHPB

      (Admiral Extreme)
      N/S120 secRepeat angioplasty with DCB, stenting
      One patient in the PTA arm had a stent inserted to achieve 70% lumen.
      HPB2000 IUN/SClinical monitoring
      Moreno-Sánchez, 2020
      • Moreno-Sánchez T.
      • Moreno-Ramírez M.
      • Machancoses F.H.
      • Pardo-Moreno P.
      • Navarro-Vergara P.F.
      • García-Revillo J.
      Efficacy of paclitaxel balloon for hemodialysis stenosis fistulae after one year compared to high-pressure balloons: a controlled, multicenter, randomized trial.
      Passeo-18 LuxHPB
      Patients were enrolled and randomised after successful vessel preparation (i.e., pre-ballooning) with an uncoated plain balloon or standard endovascular treatment.
      6 atm45 secN/SHPB + uncoated balloon80 IU/kgNo requirements
      No specific peri-operative medication was prescribed as part of the study, and left to investigator’s discretion or prescribed as per normal clinical practice.
      Clinical monitoring
      Pang, 2021
      • Pang S.Y.C.
      • Au-Yeung K.C.L.
      • Liu G.Y.L.
      • Tse R.O.H.
      • Lai D.
      • Leung W.K.W.
      • Mo K.L.
      • 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.
      IN. PACT AdmiralPB (semi-compliant balloon)≥ NP180 secBA with HPB in residual stenosis and bail-out stentingSemi-compliant balloonN/SN/SUS (1st w, and at 3, 6, 9, and 12 mo)
      Roosen, 2017
      • Roosen L.J.
      • Karamermer Y.
      • Vos J.A.
      • de Jong G.M.
      • Bos W.J.
      • Elgersma O.E.
      Paclitaxel-coated balloons do not prevent recurrent stenosis in hemodialysis access fistulae: Results of a randomized clinical trial.
      IN.PACTNoneMaximum

      16 bar
      60 secNonePlain balloon2500 IUN/SUS (3, 6, 12, and 24 mo)
      Swinnen, 2019
      • Swinnen J.J.
      • 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.
      IN.PACT AdmiralSET
      Patients were enrolled and randomised after successful vessel preparation (i.e., pre-ballooning) with an uncoated plain balloon or standard endovascular treatment.
      NP120 secSET + uncoated balloonN/S≥1 APT 1 moUS (1st and 6th w and at 3, 6, and 12 mo)
      Therasse, 2021
      • Therasse E.
      • Caty V.
      • Gilbert P.
      • Giroux M.F.
      • Perreault P.
      • Bouchard L.
      • et al.
      Safety and efficacy of paclitaxel-eluting balloon angioplasty for dysfunctional hemodialysis access: a randomized trial comparing with angioplasty alone.
      Passeo-18 LuxHPB
      Patients were enrolled and randomised after successful vessel preparation (i.e., pre-ballooning) with an uncoated plain balloon or standard endovascular treatment.
      NP60 secN/SHPB+ uncoated balloonN/SNo requirements
      No specific peri-operative medication was prescribed as part of the study, and left to investigator’s discretion or prescribed as per normal clinical practice.
      Angiography (6 mo) Telephone monitoring, flow moni-toring 3 mo
      Trerotola, 2020
      • Trerotola S.O.
      • Saad T.F.
      • Roy-Chaudhury P.
      The Lutonix AV randomized trial of paclitaxel-coated balloons in arteriovenous fistula stenosis: 2-year results and subgroup analysis.
      LutonixHPB
      Patients were enrolled and randomised after successful vessel preparation (i.e., pre-ballooning) with an uncoated plain balloon or standard endovascular treatment.
      >NP>30 sec

      (120 sec)
      Additional BA allowed

      (no stent or stent graft)
      HPB + uncoated balloonN/SNo requirements
      No specific peri-operative medication was prescribed as part of the study, and left to investigator’s discretion or prescribed as per normal clinical practice.
      Clinical monitoring
      Yin, 2021
      • Yin Y.
      • Shi Y.
      • Cui T.
      • Li H.
      • Chen J.
      • Zhang L.
      • et al.
      Efficacy and safety of paclitaxel-coated balloon angioplasty for dysfunctional arteriovenous fistulas: a multicenter randomized controlled trial.
      APERTOHPBNP120-180 secAdditional BA for residual stenosisHPBAt the investigator’s discretionNo requirements
      No specific peri-operative medication was prescribed as part of the study, and left to investigator’s discretion or prescribed as per normal clinical practice.
      Clinical monitoring

      US (6 and 12 mo)
      DCB = drug coated balloon; PB = plain balloon; HPB = high pressure balloon; DAPT = dual antiplatelet; US = ultrasonography; ASA = acetylsalicylic acid; BA = balloon angioplasty; APT = antiplatelet; NP = nominal pressure; N/S = not specified; SET = standard endovascular treatment; PTA = percutaneous angioplasty.
      Patients were enrolled and randomised after successful vessel preparation (i.e., pre-ballooning) with an uncoated plain balloon or standard endovascular treatment.
      ASA 100 mg + clopidogrel 75 mg or warfarin + ASA 50 mg if the patient was already receiving warfarin.
      17 of 20 patients in Kitrou 2015a and 11 of 20 patients in Kitrou 2015b needed balloon angioplasty with a high pressure balloon after angioplasty with DCB.
      § In cases of residual stenosis after angioplasty with a high pressure balloon (2 min), prolonged inflation (4 min) or angioplasty with a larger balloon was performed.
      If a waist persisted after initial ballooning with a non-compliant high pressure balloon (Conquest).
      One patient in the PTA arm had a stent inserted to achieve 70% lumen.
      ∗∗ No specific peri-operative medication was prescribed as part of the study, and left to investigator’s discretion or prescribed as per normal clinical practice.

      Risk of bias

      All of the included studies had a high risk of bias because of deviation from the intended intervention as it was not feasible to blind the operators to the intervention procedure (Fig. 2). Some concerns of bias also arose from the randomisation process because of insufficient description of the process. Seven trials used a sealed envelope system
      • Irani F.G.
      • Teo T.K.B.
      • Tay K.H.
      • Yin W.H.
      • Win H.H.
      • Gogna A.
      • et al.
      Hemodialysis arteriovenous fistula and graft stenoses: randomized trial comparing drug-eluting balloon angioplasty with conventional angioplasty.
      • Kitrou P.M.
      • 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).
      • Kitrou P.M.
      • Papadimatos P.
      • Spiliopoulos S.
      • Katsanos K.
      • Christeas N.
      • Brountzos E.
      • et al.
      Paclitaxel-coated balloons for the treatment of symptomatic central venous stenosis in dialysis access: results from a randomized controlled trial.
      • Kitrou P.M.
      • 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.
      ,
      • Maleux G.
      • Vander Mijnsbrugge W.
      • Henroteaux D.
      • Laenen A.
      • Cornelissen S.
      • Claes K.
      • et al.
      Multicenter, randomized trial of conventional balloon angioplasty versus paclitaxel-coated balloon angioplasty for the treatment of dysfunctioning autologous dialysis fistulae.
      ,
      • Kim J.W.
      • Kim J.H.
      • Byun S.S.
      • Kang J.M.
      • Shin J.H.
      Paclitaxel-coated balloon versus plain balloon angioplasty for dysfunctional autogenous radiocephalic arteriovenous fistulas: A prospective randomized controlled trial.
      or lot generated randomised list
      • Roosen L.J.
      • Karamermer Y.
      • Vos J.A.
      • de Jong G.M.
      • Bos W.J.
      • Elgersma O.E.
      Paclitaxel-coated balloons do not prevent recurrent stenosis in hemodialysis access fistulae: Results of a randomized clinical trial.
      but provided no further details on the methodology, and one trial
      • Fukasawa M.
      • Isobe M.
      • Nanto S.
      • Nakamura M.
      • Haruguchi H.
      • Miyake T.
      • et al.
      NF-κB decoy oligodeoxynucleotide-coated balloon catheter for arteriovenous fistula in hemodialysis.
      reported using dynamic allocation without a detailed description. One trial had partially modified the randomisation list because of shortage of device availability in the early stages of the trial.
      • Therasse E.
      • Caty V.
      • Gilbert P.
      • Giroux M.F.
      • Perreault P.
      • Bouchard L.
      • et al.
      Safety and efficacy of paclitaxel-eluting balloon angioplasty for dysfunctional hemodialysis access: a randomized trial comparing with angioplasty alone.
      Other possible bias sources were the lack of uncertainty in the blinding of the outcome assessors
      • Irani F.G.
      • Teo T.K.B.
      • Tay K.H.
      • Yin W.H.
      • Win H.H.
      • Gogna A.
      • et al.
      Hemodialysis arteriovenous fistula and graft stenoses: randomized trial comparing drug-eluting balloon angioplasty with conventional angioplasty.
      ,
      • Kitrou P.M.
      • 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).
      ,
      • Kitrou P.M.
      • 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.
      ,
      • Maleux G.
      • Vander Mijnsbrugge W.
      • Henroteaux D.
      • Laenen A.
      • Cornelissen S.
      • Claes K.
      • et al.
      Multicenter, randomized trial of conventional balloon angioplasty versus paclitaxel-coated balloon angioplasty for the treatment of dysfunctioning autologous dialysis fistulae.
      • Moreno-Sánchez T.
      • Moreno-Ramírez M.
      • Machancoses F.H.
      • Pardo-Moreno P.
      • Navarro-Vergara P.F.
      • García-Revillo J.
      Efficacy of paclitaxel balloon for hemodialysis stenosis fistulae after one year compared to high-pressure balloons: a controlled, multicenter, randomized trial.
      • Roosen L.J.
      • Karamermer Y.
      • Vos J.A.
      • de Jong G.M.
      • Bos W.J.
      • Elgersma O.E.
      Paclitaxel-coated balloons do not prevent recurrent stenosis in hemodialysis access fistulae: Results of a randomized clinical trial.
      ,
      • Kim J.W.
      • Kim J.H.
      • Byun S.S.
      • Kang J.M.
      • Shin J.H.
      Paclitaxel-coated balloon versus plain balloon angioplasty for dysfunctional autogenous radiocephalic arteriovenous fistulas: A prospective randomized controlled trial.
      and incomplete descriptions of missing data and censorship for time to event analysis.
      • Moreno-Sánchez T.
      • Moreno-Ramírez M.
      • Machancoses F.H.
      • Pardo-Moreno P.
      • Navarro-Vergara P.F.
      • García-Revillo J.
      Efficacy of paclitaxel balloon for hemodialysis stenosis fistulae after one year compared to high-pressure balloons: a controlled, multicenter, randomized trial.
      ,
      • Roosen L.J.
      • Karamermer Y.
      • Vos J.A.
      • de Jong G.M.
      • Bos W.J.
      • Elgersma O.E.
      Paclitaxel-coated balloons do not prevent recurrent stenosis in hemodialysis access fistulae: Results of a randomized clinical trial.
      ,
      • Pang S.Y.C.
      • Au-Yeung K.C.L.
      • Liu G.Y.L.
      • Tse R.O.H.
      • Lai D.
      • Leung W.K.W.
      • Mo K.L.
      • 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.
      Two trials failed to recruit the planned sample size because of slow accrual.
      • 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).
      ,
      • Roosen L.J.
      • Karamermer Y.
      • Vos J.A.
      • de Jong G.M.
      • Bos W.J.
      • Elgersma O.E.
      Paclitaxel-coated balloons do not prevent recurrent stenosis in hemodialysis access fistulae: Results of a randomized clinical trial.
      Figure 2
      Figure 2Risk of bias (A) graph and (B) summary table showing the results of the risk of bias assessment of 16 randomised controlled trials included in the systematic review and meta-analysis comparing paclitaxel coated balloon angioplasty and plain balloon angioplasty for haemodialysis arteriovenous access stenosis. + = low; ? = unclear; – = high risk of bias.

      Primary efficacy outcome: risk of loss of TLP

      Among the 16 studies that investigated paclitaxel coated balloons, 11 reported outcomes related to the six month target lesion patency. Additionally, six month data were derived from four other studies reporting 12 or 24 month target lesion revascularisation results with Kaplan–Meier curves (Supplementary Table 4). There were 185 losses of TLP (22.9%) among 808 lesions treated with DCBs and 309 losses of TLP (38.3%) among 807 lesions treated with PBs in six months. The pooled analysis of HRs (Fig. 3A) revealed a significant benefit of DCBs over PBs in terms of the six month loss of TLP (HR 0.53, 95% CI 0.42 – 0.66) with moderate heterogeneity (I2 = 30%). There was little evidence of publication bias by funnel plot (Fig. 3C) or Egger test (p = .78). The certainty of the finding for six month TLP was moderate according to GRADE methodology (Table 4).
      Figure 3
      Figure 3Results for the primary efficacy outcome (A) random effects forest plot of hazard ratios (HR) for loss of target lesion patency through six months after paclitaxel coated balloon angioplasty (DCB) vs. plain balloon (PB) angioplasty for haemodialysis arteriovenous access stenosis. Squares indicate study specific risk estimates, horizontal lines indicate 95% confidence intervals (CI). (B) Results of sensitivity analysis in which one study was removed at a time to evaluate its effect on heterogeneity. (C) Funnel plot indicating publication bias of the meta-analysis on the primary efficacy outcome (i.e., six month target lesion patency). No indication of publication bias was noted from visualisation of funnel plot and Egger’s test (p = .78). SE = standard error; IV = inverse variance.
      Table 4Summary of findings and Grades of Recommendation, Assessment, Development and Evaluation (GRADE) assessment of randomised controlled trials comparing drug coated balloon (DCB) angioplasty with plain balloon (PB) angioplasty for arteriovenous access stenosis
      OutcomesFollow up – moAnticipated absolute effects
      The risk in the intervention group is based on the assumed risk in the control group and the relative effect of the intervention.
      (95% CI)
      Relative effect (95% CI)Participants (studies) – nCertainty of the evidence (GRADE)
      The certainty of evidence was graded using the GRADE system. The GRADE system classifies the certainty of evidence as one of four grades: High, further research is very unlikely to change confidence in the estimate of effect; Moderate, further research is likely to have an important impact on confidence in the estimate of effect and may change the estimate; Low, further research is very likely to have an important impact on confidence in the estimate of effect and is likely to change the estimate; Very low, Any estimate of effect is very uncertain.
      Risk with PB angioplastyRisk with DCB angioplasty
      Loss of target lesion patency6383 per 1 000226 per 1 000 (181 – 273)HR 0.53 (0.42 – 0.66)1 615 (15 RCTs)⊕⊕⊕○

      MODERATE
      All included trials were limited by the lack of blinding of operators. In a substantial number of trials, the blinding of outcome assessors was uncertain. The increased risks of performance bias because of lack of blinding resulted in a downgrading of the GRADE class.
      There was moderate heterogeneity among the included trials (I2= 30%). However, it was chosen not to downgrade as this was probably explained by the sensitivity analysis. (The heterogeneity was reduced by excluding the study by Björkman et al., which had a short mean age of arteriovenous access). Therefore, it was chosen not to downgrade the evidence level based on inconsistency.
      Loss of target lesion patency12574 per 1 000401 per 1 000

      (330 – 477)
      HR 0.60

      (0.47 – 0.76)
      1 245

      (13 RCTs)
      ⊕⊕○○

      LOW
      All included trials were limited by the lack of blinding of operators. In a substantial number of trials, the blinding of outcome assessors was uncertain. The increased risks of performance bias because of lack of blinding resulted in a downgrading of the GRADE class.
      There was moderate heterogeneity between the trials. Therefore, the class one level was downgraded because of inconsistency.
      Loss of circuit patency6436 per 1 000262 per 1 000

      (205 – 330)
      HR 0.53

      (0.40 – 0.70)
      1 143

      (8 RCTs)
      ⊕⊕○○

      LOW
      All included trials were limited by the lack of blinding of operators. In a substantial number of trials, the blinding of outcome assessors was uncertain. The increased risks of performance bias because of lack of blinding resulted in a downgrading of the GRADE class.
      There was moderate heterogeneity between the trials. Therefore, the class one level was downgraded because of inconsistency.
      Loss of circuit patency12639 per 1 000500 per 1 000

      (429 – 575)
      HR 0.68

      (0.55 – 0.84)
      773

      (6 RCTs)
      ⊕⊕○○

      LOW
      All included trials were limited by the lack of blinding of operators. In a substantial number of trials, the blinding of outcome assessors was uncertain. The increased risks of performance bias because of lack of blinding resulted in a downgrading of the GRADE class.
      A limited number of patients (trials) was included. Therefore, the class one level was downgraded because of imprecision.
      Mortality1273 per 1 00075 per 1 000

      (51 – 110)
      OR 1.03

      (0.68 – 1.56)
      1 396

      (11 RCTs)
      ⊕⊕⊕⊕

      HIGH
      CI = confidence interval; HR = hazard ratio; OR = odds ratio; RCT = randomised controlled trial; GRADE = Grading, Recommendations, Assessment, Development, and Evaluation.
      The risk in the intervention group is based on the assumed risk in the control group and the relative effect of the intervention.
      The certainty of evidence was graded using the GRADE system. The GRADE system classifies the certainty of evidence as one of four grades: High, further research is very unlikely to change confidence in the estimate of effect; Moderate, further research is likely to have an important impact on confidence in the estimate of effect and may change the estimate; Low, further research is very likely to have an important impact on confidence in the estimate of effect and is likely to change the estimate; Very low, Any estimate of effect is very uncertain.
      All included trials were limited by the lack of blinding of operators. In a substantial number of trials, the blinding of outcome assessors was uncertain. The increased risks of performance bias because of lack of blinding resulted in a downgrading of the GRADE class.
      § There was moderate heterogeneity among the included trials (I2= 30%). However, it was chosen not to downgrade as this was probably explained by the sensitivity analysis. (The heterogeneity was reduced by excluding the study by Björkman et al., which had a short mean age of arteriovenous access). Therefore, it was chosen not to downgrade the evidence level based on inconsistency.
      There was moderate heterogeneity between the trials. Therefore, the class one level was downgraded because of inconsistency.
      A limited number of patients (trials) was included. Therefore, the class one level was downgraded because of imprecision.
      To analyse the impact of individual studies on heterogeneity, a sensitivity analysis was performed. The heterogeneity was decreased by excluding the study by Björkman et al.
      • 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).
      (I2 = 9%; Fig. 3B). None of the omissions changed the favourable effect of DCBs. The favourable effect was also consistent in sensitivity analysis when including only multicentre trials and trials with non-industrial funding (Supplementary Fig. 1).

      Secondary efficacy outcome

      Instead of pooling HRs for TLP loss during the entire study periods of the individual studies, HRs through six and 12 months were pooled separately. This was because of the possibility of time varying treatment effects of the DCBs that was evident through visual inspection of the Kaplan–Meier curves. DCBs were associated with reduced risk of TLP loss through 12 months (nine studies, HR 0.60, 95% CI 0.47 – 0.76; Fig. 4A) with moderate heterogeneity (I2 = 44%). The certainty of this finding was low because of the risk of performance bias and inconsistency (Table 4).
      Figure 4
      Figure 4Results for the secondary efficacy outcome. Random effects forest plot of hazard ratios (HR) for (A) loss of target lesion patency through 12 months, (B) loss of circuit patency through six months, and (C) loss of circuit patency through 12 months after paclitaxel coated balloon (DCB) angioplasty compared with plain balloon (PB) angioplasty for haemodialysis arteriovenous access stenosis. Squares indicate study specific risk estimates, horizontal lines indicate 95% confidence intervals (CI). SE = standard error; IV = inverse variance.
      Six studies
      • Trerotola S.O.
      • Saad T.F.
      • Roy-Chaudhury P.
      The Lutonix AV randomized trial of paclitaxel-coated balloons in arteriovenous fistula stenosis: 2-year results and subgroup analysis.
      ,
      • Irani F.G.
      • Teo T.K.B.
      • Tay K.H.
      • Yin W.H.
      • Win H.H.
      • Gogna A.
      • et al.
      Hemodialysis arteriovenous fistula and graft stenoses: randomized trial comparing drug-eluting balloon angioplasty with conventional angioplasty.
      ,
      • Kitrou P.M.
      • 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.
      ,
      • Liao M.T.
      • Lee C.P.
      • Lin T.T.
      • Jong C.B.
      • Chen T.Y.
      • Lin L.
      • et al.
      A randomized controlled trial of drug-coated balloon angioplasty in venous anastomotic stenosis of dialysis arteriovenous grafts.
      ,
      • Therasse E.
      • Caty V.
      • Gilbert P.
      • Giroux M.F.
      • Perreault P.
      • Bouchard L.
      • et al.
      Safety and efficacy of paclitaxel-eluting balloon angioplasty for dysfunctional hemodialysis access: a randomized trial comparing with angioplasty alone.
      ,
      • Yin Y.
      • Shi Y.
      • Cui T.
      • Li H.
      • Chen J.
      • Zhang L.
      • et al.
      Efficacy and safety of paclitaxel-coated balloon angioplasty for dysfunctional arteriovenous fistulas: a multicenter randomized controlled trial.
      reported circuit patency results up to 12 months, whereas only six month results were available in two studies.
      • Lookstein R.A.
      • Haruguchi H.
      • Ouriel K.
      • Weinberg I.
      • Lei L.
      • Cihlar S.
      • et al.
      Drug-coated balloons for dysfunctional dialysis arteriovenous fistulas.
      ,
      • Kitrou P.M.
      • 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).
      When the eight studies were pooled, DCBs were associated with a significantly decreased risk of six month circuit patency loss compared with PBs, with moderate heterogeneity (Fig. 4B, HR 0.53, 95% CI 0.40 – 0.70), I2 = 46%). A similar benefit was observed in the analysis of CP through 12 months (Fig. 4C; HR 0.68, 95% CI 0.55 – 0.84, I2 = 11%). The certainty of findings for six month and 12 month CP was considered low because of inconsistency and imprecision (Table 4).

      Safety outcomes

      Safety outcomes were described in 11 studies. Peri-procedural adverse events were rare in both the DCB and PB groups (Supplementary Table 5). Notably, in studies in which DCBs were used after vessel preparation with high pressure balloon (HPB), procedural complications occurred during HPB angioplasty (i.e., before randomisation to the DCB or PB groups) and were not captured as procedural complications of DCB angioplasty.
      The 12 month all cause mortality rate was pooled from nine studies with 1 396 patients (DCB, n = 698; PB, n = 698). With 52 deaths in the DCB group and 51 deaths in the PB group (crude mortality rate: DCB, 7.4%; PB, 7.3%), the pooled analysis indicated that DCBs had no significant impact on 12 month mortality (OR 1.03, 95% CI 0.68 – 1.56, I2 = 0%) (Fig. 5). The certainty of this finding was high (Table 4).
      Figure 5
      Figure 5Random effects forest plot of odds ratios (OR) for mortality through 12 months after paclitaxel coated balloon (DCB) angioplasty compared with plain balloon (PB) angioplasty for haemodialysis arteriovenous access stenosis. Squares indicate study specific risk estimates, horizontal lines indicate 95% confidence intervals (CI). MH = Mantel-Haenszel.

      Subgroup analysis

      Subgroup analysis according to the type of AV access suggested a similar benefit of DCB angioplasty in terms of risk of loss of TLP in both native fistulas (HR 0.59, 95% CI 0.43 – 0.80, I2 = 39%) and grafts (HR 0.38, 95% CI 0.24 – 0.61, I2 = 0% for studies including > 50% AVGs) through six months (Supplementary Figs. 2-4). There was also a favourable effect of DCBs for TLP through 12 months and CP through six months, regardless of the fistula type. Subgroup analysis of studies with a mean access age > 2 years favoured DCBs over PBs in terms of both the risk of loss of TLP and CP up to 12 months (Supplementary Fig. 5). There were only two studies with a mean or median access age < 2 years,
      • 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).
      ,
      • Kim J.W.
      • Kim J.H.
      • Byun S.S.
      • Kang J.M.
      • Shin J.H.
      Paclitaxel-coated balloon versus plain balloon angioplasty for dysfunctional autogenous radiocephalic arteriovenous fistulas: A prospective randomized controlled trial.
      and the pooled results did not show a benefit of DCBs in the efficacy outcomes (Supplementary Fig. 6).
      Additionally, an unplanned exploratory subgroup analysis was performed based on the applied device and methods of vessel preparation. When grouped according to the DCB device, IN.PACT (10 studies) and Passeo-18 Lux (2 studies) were associated with a significant benefit for the risk of loss of TLP and CP (Supplementary Figs. 7 and 8). The pooled result of two studies using the Lutonix showed a non-significant smaller effect size in all efficacy outcomes (Supplementary Fig. 9). The APERTO was used in only one study, in which DCBs had a non-significant benefit over PBs (Supplementary Fig. 10). Regardless of the device used, there was no significant difference in the 12 month all cause mortality between the DCB and PB groups (Supplementary Figs. 7-10).

      Discussion

      The combined results of 16 RCTs in the current analysis demonstrate that DCB angioplasty for haemodialysis access stenosis has a significant benefit in terms of six and 12 month target lesion patency and circuit patency compared with PB angioplasty. Peri-procedural complications involving DCB angioplasty were rare, and there was no evidence of increased mortality up to 12 months.
      Pooled results of RCTs from previous meta-analyses on the effectiveness of DCB use in dialysis have been conflicting. Some saw insignificant differences in treatment effects between DCB and PB angioplasty,
      • 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.
      ,
      • Cao Z.
      • Li J.
      • Zhang T.
      • Zhao K.
      • Zhao J.
      • Yang Y.
      • et al.
      Comparative effectiveness of drug-coated balloon vs balloon angioplasty for the treatment of arteriovenous fistula stenosis: a meta-analysis.
      ,
      • Liao M.T.
      • Chen M.K.
      • Hsieh M.Y.
      • Yeh N.L.
      • Chien K.L.
      • Lin C.C.
      • 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.
      whereas others reported significant between group differences favouring DCBs for six month target lesion patency outcome.
      • Kennedy S.A.
      • Mafeld S.
      • Baerlocher M.O.
      • Jaberi A.
      • Rajan D.K.
      Drug-coated balloon angioplasty in hemodialysis circuits: a systematic review and meta-analysis.
      ,
      • Yan Wee I.J.
      • Yap H.Y.
      • Hsien Ts'ung L.T.
      • Lee Qingwei S.
      • Tan C.S.
      • Tang T.Y.
      • et al.
      A systematic review and meta-analysis of drug-coated balloon versus conventional balloon angioplasty for dialysis access stenosis.
      ,
      • Chen X.
      • Liu Y.
      • Wang J.
      • Zhao J.
      • Singh N.
      • Zhang W.W.
      A systematic review and meta-analysis of the risk of death and patency after application of paclitaxel-coated balloons in the hemodialysis access.
      This may be because of the number of studies included. Early trials had relatively small sample size and, because of the heterogeneity of these trials, inclusion or exclusion of individual studies may lead to different conclusions. Up to date systematic reviews with a comprehensive and thorough literature search and sound methodology are vital. The present meta-analysis differs from previous meta-analyses in that a comprehensive literature search was performed, updated data from recent large trials were included, and time to event analysis for target lesion and circuit patency was performed.
      All RCTs included in this study addressed patency outcomes of either the target lesion or the access circuit with six to 24 month follow ups. The trial interventions in all patients, except those from three trials,
      • Lookstein R.A.
      • Haruguchi H.
      • Ouriel K.
      • Weinberg I.
      • Lei L.
      • Cihlar S.
      • et al.
      Drug-coated balloons for dysfunctional dialysis arteriovenous fistulas.
      ,
      • Roosen L.J.
      • Karamermer Y.
      • Vos J.A.
      • de Jong G.M.
      • Bos W.J.
      • Elgersma O.E.
      Paclitaxel-coated balloons do not prevent recurrent stenosis in hemodialysis access fistulae: Results of a randomized clinical trial.
      ,
      • Swinnen J.J.
      • 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.
      were prompted by clinical dysfunction. Re-interventions of the index lesion in all but two trials
      • Roosen L.J.
      • Karamermer Y.
      • Vos J.A.
      • de Jong G.M.
      • Bos W.J.
      • Elgersma O.E.
      Paclitaxel-coated balloons do not prevent recurrent stenosis in hemodialysis access fistulae: Results of a randomized clinical trial.
      ,
      • Swinnen J.J.
      • 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.
      were also indicated only when stenosis was accompanied by clinical dysfunction. As revascularisations are recommended only in access stenosis related to clinical dialysis dysfunction and a superior six month post-intervention outcome is a reasonable goal for novel treatments,
      • Lok C.E.
      • Huber T.S.
      • Lee T.
      • Shenoy S.
      • Yevzlin A.S.
      • Abreo K.
      • et al.
      KDOQI clinical practice guideline for vascular access: 2019 update.
      the findings of the present meta-analysis are clinically relevant and applicable.
      However, the quality of the evidence regarding patency outcomes was moderate to low because of insufficient blinding of the operator and significant heterogeneity of the trials (Fig. 4). When the source of heterogeneity of the primary outcome was systematically evaluated, the study by Björkman et al.
      • 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).
      made a major contribution to the heterogeneity. The study differed from others in that the age of the fistulas was relatively low (mean age 0.5 years for DCB group) and that the majority of the cases were radiocephalic AVFs (89.7%) with lower mean fistula age (0.5 years for the DCB group). In addition, Björkman’s study was terminated before recruiting the planned sample size because of slow accrual. While there is a possibility that fistula age may lead to a differential effect in the efficacy of DCBs, it was not possible to draw a definite conclusion. There was one trial that included only radiocephalic fistulas, and there was no significant difference in the TLP between the DCB and the PB groups. Among the other studies, only Trerotola et al.
      • Trerotola S.O.
      • Saad T.F.
      • Roy-Chaudhury P.
      The Lutonix AV randomized trial of paclitaxel-coated balloons in arteriovenous fistula stenosis: 2-year results and subgroup analysis.
      presented trial level subgroup analysis results according to fistula type, and they showed no difference in two year lesion patency. Considering fistula age, there was no difference in two year lesion patency based on fistula age according to Trerotola et al., whereas Irani et al.
      • Irani F.G.
      • Teo T.K.B.
      • Tay K.H.
      • Yin W.H.
      • Win H.H.
      • Gogna A.
      • et al.
      Hemodialysis arteriovenous fistula and graft stenoses: randomized trial comparing drug-eluting balloon angioplasty with conventional angioplasty.
      showed that lesion patency was associated with a difference in fistula age within the DCB group (higher patency in fistulas > 2 years). The pooling of the trial level subgroup data was not possible because of non-availability of detailed data.
      The trials also varied in procedures, study populations, lesion type, and the devices used. DCBs, although not new, are newly being applied to dialysis access stenosis, and the techniques are still evolving. There are still uncertainties regarding the ideal dose and application techniques in arterialised venous beds, optimal vessel preparation methods, and possible divergent effects on different segments of the arteriovenous access circuits. Such uncertainties were reflected in the trial protocols and are likely to have contributed to varying baseline patency rates and effect sizes. Adequate vessel preparation using an HPB has become a prerequisite before using DCBs over the years, and sufficient inflation time is emphasised in the more recent trials. Although the efficacy of DCBs was generally consistent regardless of vessel preparation using HPBs (Supplementary Figs. 11-13), further advances in adjunctive procedures and devices may affect the effect size of DCB angioplasty and thus need to be considered when applying DCBs.
      Different devices demonstrated different efficacy outcomes. According to the present subgroup analysis, only trials using the IN.PACT DCB and Passeo-18 Lux showed significant benefits of DCBs over PBs. Although it is possible that differences in the drug dose (IN.PACT, 3.0–3.5 ug/mm2; Passeo-18 Lux 3.0 μg/mm2; APERTO 3.0 μg/mm2; Lutonix 2 μg/mm2) or the excipient may have affected the outcome, this needs further investigation as there were only two trials each of Lutonix and Passeo-18 Lux, and one trial of APERTO included in the present review.
      Adverse effects and costs are as important as efficacy when considering the adoption of new devices. In 2018, a meta-analysis of 28 RCTs
      • 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.
      suggested an increase in late mortality associated with paclitaxel eluting devices (DCBs and drug eluting stents) in the lower extremities. Although the mechanism of increased mortality is unclear and the individual patient level data are contradictory, this finding underscores the importance of long term surveillance of paclitaxel eluting devices. The increase in mortality has not been demonstrated in the coronary system,
      • Scheller B.
      • Vukadinovic D.
      • Jeger R.
      • Rissanen T.T.
      • Scholz S.S.
      • Byrne R.
      • et al.
      Survival after coronary revascularization with paclitaxel-coated balloons.
      and there are insufficient long term data in arteriovenous fistulas. There was no difference in mortality in the current analysis; however, mortality was only examined up to one year because of limited periods of follow up. Because the differences in mortality risk in the Katsanos' meta-analysis
      • 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.
      were evident only after two years, further prospective cohort studies and large scale real world data with long term surveillance are warranted. The cost effectiveness of DCBs was not examined in the present study. Only one trial
      • Kitrou P.M.
      • 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).
      performed cost effectiveness analysis, and DCBs had more favourable incremental cost effectiveness than PBs. As the cost effectiveness of DCBs is likely to differ according to the treated lesion, use of adjunctive devices, and local reimbursement systems, the feasibility of DCBs within various clinical settings needs to be explored. In addition, with various other intervention techniques such as cutting balloons, stent grafts, and ultra high pressure balloons available, studies comparing the efficacy, cost effectiveness, and safety between various interventions for dialysis access angioplasty would be of great value in determining the optimal treatment.
      Several ongoing or completed but unpublished RCTs were identified (Supplementary Table 2), including several large RCTs and trials investigating the effectiveness of DCBs in various clinical situations (e.g., non-maturing AVF stenosis, AVF with early failure, and stenosis of stent grafts placed in AVFs). Also, more diverse paclitaxel eluting devices, sirolimus eluting DCBs, and scoring DCBs are being evaluated. It is hoped that the results of these trials provide additional evidence for DCBs in dialysis access.
      The present review has limitations. First, there may have been undetected publication bias regarding other secondary analyses, which it was not possible to assess because of the small number of trials included. Second, one source of potential bias is that the number of events or HRs of several studies were extracted from Kaplan–Meier curves. Efficacy data from two studies that did not report appropriate survival data had to be excluded.
      • Maleux G.
      • Vander Mijnsbrugge W.
      • Henroteaux D.
      • Laenen A.
      • Cornelissen S.
      • Claes K.
      • et al.
      Multicenter, randomized trial of conventional balloon angioplasty versus paclitaxel-coated balloon angioplasty for the treatment of dysfunctioning autologous dialysis fistulae.
      ,
      • Karmota A.G.
      Paclitaxel coated-balloon (PCB) versus standard plain old balloon (POB) fistuloplasty for failing dialysis access.
      Finally, no patient level data were available, and thus the subgroup analysis was limited to the results published. It was not possible to perform the planned subgroup analysis of central vein stenosis or recurrent lesions because of the small amount of literature providing the necessary data separately. In addition, the lack of detailed individual data limited evaluation of the efficacy of DCBs in different types of stenotic lesions. Sonographic and histopathological evidence suggests that AV access stenosis is a heterogeneous entity with different pathophysiology.
      • Steiner K.
      • Ramanarayanan S.
      • Metcalfe M.
      • Jeevaratnum P.
      • Selvakumar S.
      • Narula A.
      Ultrasound appearances and histological correlation of native arteriovenous fistula stenoses - A retrospective case series.
      ,
      • Yamamoto Y.
      • Nakamura J.
      • Nakayama Y.
      • Hino H.
      • Kobayashi H.
      • Sugiura T.
      Relationship between the outcomes of stent placement and the properties of arteriovenous graft outflow vein stenotic lesions.
      In stenosis caused by venous constriction with slight to no increases in intimal thickness, DCB may not be as effective as in stenosis caused by neointimal hyperplasia. Thus, further investigations on the effectiveness of DCBs in stenoses of different morphological characteristics, as well as comparative studies on different treatment modalities according to lesion type, are needed.
      In conclusion, this meta-analysis demonstrates an advantage of DCB angioplasty over PB angioplasty in treating arteriovenous dialysis access stenosis regarding patency outcome up to 12 months. Considering the moderate quality of evidence, further accumulation of evidence from ongoing trials will be helpful in guiding clinical practice.

      Conflict of interest

      None.

      Funding

      This study was supported by the Seoul National University Hospital (SNUH) Research Fund (Grant No. 23-2017-0100 ).

      Appendix A. Supplementary data

      The following are the Supplementary data to this article:

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