Paclitaxel coated-balloon (PCB) versus standard plain old balloon (POB) fistuloplasty for failing dialysis access

Abstract

Introduction This study aimed to evaluate the safety and efficacy of paclitaxel-coated balloon compared with conventional plain balloon for the treatment of failing native dialysis access. Materials and methods This prospective study included 60 patients presenting to the Kasr Alainy Hospitals and Aseer Central Hospital in the period from September 2015 to December 2017 with failing native vascular access. Dilatation with a plain balloon was done in 30 patients (group I) and with a paclitaxel-coated balloon in 30 patients (group II) with either stenosis or occlusion. The majority were outflow lesions, with 20 (66.7 %) patients in group I and 21 (70%) patients in group II. Mean balloon diameter was 7.1mm (± 1.5mm) compared with 6.5mm (± 1.2mm) and length 66mm (± 19.1mm) compared with 54.6mm (± 15.7mm), respectively. Safety endpoint was reported as 30 day’s freedom from procedure-related major complications and mortality. Procedural technical success was defined as a residual diameter 30% or less for treated lesions. Target lesion primary patency, circuit primary patency and secondary patency were reported at 3, 6 and 12 months. Results There were no 30-day procedure-related major complications or mortality in either group. Procedural technical success of 100% was achieved in both groups. Target lesion primary patency, circuit primary patency and secondary patency in group II were better than in group I, especially at 12 months (90% vs 66.7%, 83.3% vs 60% and 96.7% vs 93.3%, respectively). There was a statistically significant difference in target lesion primary patency (p = 0.029) in patients who were treated with paclitaxel-coated balloon angioplasties. Conclusion The paclitaxel-coated balloon proved to be safe and effective, and improved the patency of failing vascular access. Results are comparable with previous studies.

Drug‐Coated Balloon Versus Plain Balloon Angioplasty for Hemodialysis Dysfunction: A Meta‐Analysis of Randomized Controlled Trials

“…The resultant 49 studies were further screened by full‐text assessment to remove publications without full text (n=27), retrospective studies (n=1), and studies without primary outcomes of interest reported (n=2), yielding 19 studies based on 18 unique RCTs. 8 , 11 , 12 , 13 , 14 , 15 , 16 , 17 , 18 , 19 , 20 , 21 , 22 , 23 , 24 , 25 , 26 , 27 , 28 A total of 877 and 875 patients in the DCB and PBA groups, respectively, were included in the present meta‐analysis (Table 1 ). These studies were conducted in the United States, Korea, China, Egypt, Spain, Australia, Finland, Singapore, Belgium, Greece, Taiwan, the Netherlands, and Canada.…”

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

“…Efficacy data from two studies that did not report appropriate survival data had to be excluded. 27,33 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.…”

“…Among the retrieved trials, three RCTs were excluded because of insufficient data. RCTs by Karmota 33 and Arabi et al 32 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 36 was excluded because of limited information to assess its eligibility.…”

Angioplasty for dysfunctional arteriovenous fistulas: a meta-analysis of recent randomized controlled trials compared paclitaxel-coated balloon versus conventional balloon angioplasty

“…It has been reported in some small studies that the use of drug-coated balloons (DCB) with a layer of antiproliferative drug paclitaxel may have the potential to improve outcomes. In contrast, other studies reported a contradictory result (4)(5)(6)(7)(8)(9)(10).…”