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

Abstract

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.

Paclitaxel-assisted balloon angioplasty of venous stenosis in haemodialysis access: PAVE RCT

“…15,16 Since then, a number of small studies have included AVFs only, and have excluded patients with arteriovenous grafts (AVGs), intravascular stents or a central stenosis. [17][18][19][20][21] These studies gave conflicting results, and a small study in those with a central venous stenosis suggested benefit. 22 Four larger studies, each with over 100 subjects, have been published.…”

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

“…AVF with native vein was the most common type of access; only 128 lesions used AVG. Although one trial included central vein lesions exclusively, 24 in nine trials, 14,15,23,25,27,30,34,35,38 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).…”

“…In four trials, DCB angioplasty was performed without pre-dilation of the stenotic lesion, 23,24,26,29 whereas DCBs were used after vessel preparation using high pressure uncoated balloons in 11 trials. 14,15,21,22,24,27,28,30,34,37,38 Of these, six trials 14,15,21,28,30,37 had patients enrolled and randomised to either the DCB or PB groups when successful pre-dilation was achieved.…”

Drug-coated balloons for dysfunctional hemodialysis venous access: A patient-level meta-analysis of randomized controlled trials

“…The search strategy retrieved 503 studies; after de-duplication and screening, 11 RCTs [16,17,[41][42][43][44][45][46][47][48] comprising 1,243 patients were eligible and included in the meta-analysis [ Figure 1]. One RCT was excluded as no curve was provided for graphical reconstruction to retrieve patient-level patency information [49].…”

“…However, findings are mixed in the setting of hemodialysis access – some meta-analyses significantly favoured DCB over PTA [12, 13], while others reported no significant benefit [14, 15]. Not long ago, two new randomized controlled trials (RCTs) on this subject were published [16, 17]; this article aims to re-evaluate the field with these new inclusions. To our knowledge, this is first meta-analysis which includes these 2 new RCTs.…”