Paclitaxel-Coated Balloon Angioplasty of Venous Stenoses in Native Dialysis Fistulas: Primary and Secondary Patencies at 6 and 12 Months

Abstract

Purpose:When dialysis access stenoses are dilated by noncoated balloons, respective primary and secondary patencies hardly reach 50 per cent and 85 per cent at one year. This study determines the primary and secondary patency rates at 6 and 12 months for venous stenoses treated by paclitaxel-coated balloon (PCB) angioplasty in native hemodialysis accesses.Materials and Methods:From 2012 to 2014, 70 venous stenoses in 41 patients benefited from PCB angioplasties. The patients’ mean age was 62.5 ± 13.8 years’ standard deviation (SD) with 75 per cent male gender, 31.7 per cent diabetes, and 65.9 per cent arterial hypertension. There were 58.5 per cent forearm fistulas and 41.5 per cent arm fistulas. Primary and secondary patency rates were prospectively established by using the Kaplan-Meier technique and tested by using the log-rank test.Results:The primary patency rates ± SD were 81.4 ± 4.6 per cent and 60 ± 5.9 per cent at 6 and 12 months, respectively. The secondary patency rates ± SD reached 94.3 ± 2.8 per cent at 6 months and 91.4 ± 3.3 per cent at 12 months.Conclusion:This study shows an improvement of the primary and secondary patency rates at 6 and 12 months when venous stenoses of native dialysis fistulas are treated by PCB. The indications for PCB, however, remain to be established by larger randomized studies.

Paclitaxel-Coated Balloon Angioplasty for Early Restenosis of Central Veins in Hemodialysis Patients: A Single Center Initial Experience

“…Moreover, a recent randomized controlled clinical trial has shown good outcomes of PCBA for stenosis in dialysis access ( 10 22 ). Other recent non-randomized studies have also reported good outcomes of PCBA for the treatment of stenosis of native dialysis fistula and in-stent stenosis of dialysis fistula ( 23 24 ).…”

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

“…This randomized controlled trial (RCT) aimed to investigate the potential added value of DCBs in patients with dysfunctional autogenous AVFs, focusing on a specific access type to lessen heterogeneity. This RCT has two main strengths: it is the first randomized comparative study to evaluate the efficacy of DBA exclusively in dysfunctional RCAVFs as opposed to other types of dialysis access, and it has a relatively long follow-up period compared to previously published studies ( 9 10 12 16 17 18 19 20 ).…”

“…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.…”

Drug eluting balloons for resistant arteriovenous dialysis access stenosis

“…Although a significant difference occurred in favor of PCB at 6 months, there was no significant difference between treatments at 1 year (at 6 months: PCB 70% vs. CBA 0%; p<0.01; at 1 year: 20% vs. 0%; p>0.05) (15). A recent prospective single-arm study came from Verbeeck et al (16) using IN.PACT PCB (Medtronic, Brescia Italy). Primary patency rates were 81.4% ± 4.6% and 60% ± 5.9% at 6 and 12 months, respectively (16).…”

“…A recent prospective single-arm study came from Verbeeck et al (16) using IN.PACT PCB (Medtronic, Brescia Italy). Primary patency rates were 81.4% ± 4.6% and 60% ± 5.9% at 6 and 12 months, respectively (16). Finally, another three retrospective studies are available in the literature each one with a specific characteristic.…”