Multicentre, randomised, blinded, control trial of drug-eluting balloon vs Sham in recurrent native dialysis fistula stenoses

Swinnen, John; Hitos, Kerry; Kairaitis, Lukas; Gruenewald, Simon M.; Larcos, George; Farlow, David; Huber, David; Cassorla, Gabriel; Leo, Christopher Cheang Han; Villalba, Laurencia; Allen, Richard D.; Niknam, Farshid; Burgess, David

doi:10.1177/1129729818801556

Cited by 54 publications

(76 citation statements)

References 19 publications

(24 reference statements)

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“…After reviewing the titles and abstracts, 999 publications were excluded. After reviewing the full text of 20 publications, 11 publications were included in the final qualitative and quantitative analyses, with a total of 976 patients [8][9][10][11][12][13][14][15][16][17][18]. The flow diagram of the systematic search process is depicted in…”

Section: Study Selectionsmentioning

confidence: 99%

Drug-coated balloon versus conventional balloon angioplasty of hemodialysis arteriovenous fistula or graft: A systematic review and meta-analysis of randomized controlled trials

et al. 2020

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Background Restenosis remains a significant problem in endovascular therapy for hemodialysis vascular access. Drug-coated balloon (DCB) angioplasty decreases restenosis in peripheral and coronary artery diseases. The aim of this systematic review and meta-analysis is to assess the patency outcomes following DCB angioplasty, as compared to conventional balloon (CB) angioplasty for the stenosis of hemodialysis vascular access. Methods A comprehensive search in the MEDLINE, EMBASE, and CENTRAL databases was conducted in order to identify eligible randomized controlled trials evaluating DCB angioplasty for hemodialysis vascular access dysfunction. The primary endpoint was the 6-month target lesion primary patency and the secondary endpoints were 12-month target lesion primary patency and procedure-related complications. Risk ratios (RR) were pooled and relevant subgroups were analyzed separately. Results Eleven randomized controlled trials comprised of 487 patients treated with DCB angioplasty and 489 patients treated with CB angioplasty were included. There were no significant

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Section: Study Selectionsmentioning

confidence: 99%

Drug-coated balloon versus conventional balloon angioplasty of hemodialysis arteriovenous fistula or graft: A systematic review and meta-analysis of randomized controlled trials

et al. 2020

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“…It is also the first large multicenter trial to study DCBs in AVFs, and as such builds on the growing literature regarding the use of DCBs in arteriovenous access circuits. Most, but not all, randomized controlled trials to date (all of which are small and most of which are single-center) have shown a benefit for DCB use in AVGs and AVFs (17)(18)(19)(20)(21)(22)(23)30,31). Some trials have used a DCB-first approach, and others an approach similar to that of the present study, namely DCB angioplasty after successful vessel preparation.…”

Section: Discussionmentioning

confidence: 79%

“…Paclitaxel-coated balloon angioplasty has been shown in most, but not all, small randomized trials to yield superior patency compared with standard PTA in hemodialysis circuits (17)(18)(19)(20)(21)(22)(23). The present large multicenter randomized study was designed to test the hypothesis that drug-coated balloon (DCB) angioplasty performed after successful vessel preparation with high-pressure PTA would yield superior outcomes.…”

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confidence: 99%

The Lutonix AV Randomized Trial of Paclitaxel-Coated Balloons in Arteriovenous Fistula Stenosis: 2-Year Results and Subgroup Analysis

Trerotola

Saad

Roy‐Chaudhury³

2020

Journal of Vascular and Interventional Radiology

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To present final, 2-year results of a randomized trial comparing paclitaxel-coated vs uncoated balloon angioplasty following vessel preparation with ultra-high-pressure percutaneous transluminal angioplasty (PTA) in hemodialysis arteriovenous fistulae (AVFs). Materials and Methods: Twenty-three sites enrolled 285 subjects with dysfunctional AVFs located in the arm. Before 1:1 randomization, successful vessel preparation was achieved (full waist effacement, < 30% residual stenosis). Follow-up was clinically driven except for a 6-month office visit. Results: Ninety-six of 141 subjects in the drug-coated balloon (DCB) arm and 111 of 144 in the control arm completed the study. Target lesion primary patency (TLPP) rates for the DCB and control groups were 58% ± 4 vs 46% ± 4 (P ¼ .02) at 9 months, 44% ± 5 vs 36% ± 4 (P ¼ .04) at 12 months, 34% ± 5 vs 28% ± 4 (P ¼ .06) at 18 months, and 27% ± 4 vs 24% ± 4 (P ¼ .09) at 24 months, respectively. Mean time to TLPP event for subjects with an event was longer for DCBs (322 vs 207 d; P < .0001). Fewer interventions were needed to maintain target lesion patency in the DCB group at 9 months (P ¼ .02) but not at 12 (P ¼ .08), 18 (P ¼ .13), or 24 months (P ¼ .19). The noninferiority safety target was met at all intervals (P < .01). Mortality did not differ between groups (P ¼ .27). Post hoc analyses showed equivalent DCB effect in all subgroups. Conclusions: Two-year results demonstrate long-term safety and variable efficacy of DCB angioplasty in AVFs. ABBREVIATIONS ACPP ¼ access circuit primary patency, AVF ¼ arteriovenous fistula, AVG ¼ arteriovenous graft, CONSORT ¼ Consolidated Standards of Reporting Trials, DCB ¼ drug-coated balloon, ESRD ¼ end-stage renal disease, RVD ¼ reference vessel diameter, TLP ¼ target lesion patency, TLPP ¼ target lesion primary patency Improving outcomes in access maintenance percutaneous transluminal angioplasty (PTA) is a highly desirable goal, given the modest outcomes afforded by standard PTA and the burgeoning cost of access creation and maintenance (1,2). Although it remains controversial whether maintenance PTA prolongs access life (3-6), maintenance PTA reduces the thrombosis rate and associated hospitalization, catheter placement, and missed dialysis sessions (7-9). In addition to

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“…To date, multiple observational and randomized controlled studies have evaluated the use of DCBs for prolonging patency, but caution should be taken when interpreting the results due to clinical heterogeneity resulting from the non-uniform level of intervention ( 8 9 11 12 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 ). In a retrospective study in 2014, Patanè et al ( 9 ) presented a case series of 26 patients who had juxta-anastomotic radiocephalic stenosis treated using DBA.…”

Section: Discussionmentioning

confidence: 99%

Paclitaxel-Coated Balloon versus Plain Balloon Angioplasty for Dysfunctional Autogenous Radiocephalic Arteriovenous Fistulas: A Prospective Randomized Controlled Trial

Kim

Byun

et al. 2020

Korean J Radiol

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Objective To report the mid-term results of a single-center randomized controlled trial comparing drug-coated balloon angioplasty (DBA) and plain balloon angioplasty (PBA) for the treatment of dysfunctional radiocephalic arteriovenous fistulas (RCAVFs). Materials and Methods In this prospective study, 39 patients (mean age, 62.2 years; 21 males, 18 females) with RCAVFs failing due to juxta-anastomotic stenosis were randomly assigned to undergo either both DBA and PBA (n = 20, DBA group) or PBA alone (n = 19, PBA group) between June 2016 and June 2018. Primary endpoints were technical and clinical success and target lesion primary patency (TLPP); secondary outcomes were target lesion secondary patency (TLSP) and complication rates. Statistical analysis was performed using the Kaplan-Meier product limit estimator. Results Demographic data and baseline clinical characteristics were comparable between the groups. Technical and clinical success rates were 100% in both groups. There was no significant difference between the groups in the mean duration of TLPP (DBA group: 26.7 ± 3.6 months; PBA group: 27.0 ± 3.8 months; p = 0.902) and TLSP (DBA group: 37.3 ± 2.6 months; PBA group: 40.4 ± 1.5 months; p = 0.585). No procedural or post-procedural complications were identified. Conclusion Paclitaxel-coated balloon use did not significantly improve TLPP or TLSP in the treatment of juxta-anastomotic stenosis of dysfunctional RCAVFs.

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Multicentre, randomised, blinded, control trial of drug-eluting balloon vs Sham in recurrent native dialysis fistula stenoses

Cited by 54 publications

References 19 publications

Drug-coated balloon versus conventional balloon angioplasty of hemodialysis arteriovenous fistula or graft: A systematic review and meta-analysis of randomized controlled trials

Drug-coated balloon versus conventional balloon angioplasty of hemodialysis arteriovenous fistula or graft: A systematic review and meta-analysis of randomized controlled trials

The Lutonix AV Randomized Trial of Paclitaxel-Coated Balloons in Arteriovenous Fistula Stenosis: 2-Year Results and Subgroup Analysis

Paclitaxel-Coated Balloon versus Plain Balloon Angioplasty for Dysfunctional Autogenous Radiocephalic Arteriovenous Fistulas: A Prospective Randomized Controlled Trial

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