Drug Coated Balloon Angioplasty in Failing AV Fistulas

Abstract

Background Restenosis remains a problem in hemodialysis access interventions. Paclitaxel-coated balloons have shown promise in reducing access-related restenosis in small trials. The primary hypotheses for our multicenter trial were superior effectiveness at 180 days and noninferior safety at 30 days of a drug-coated balloon compared with conventional angioplasty for treatment of dysfunctional arteriovenous fistulas.Design, setting, participants, & measurements This randomized trial enrolled 285 patients with dysfunctional arteriovenous fistulas at 23 centers. Grafts, central venous stenoses, thrombosed fistulas, and immature fistulas were excluded. All patients received angioplasty of the lesion responsible for access dysfunction. After successful angioplasty (#30% residual stenosis), lesions were treated with either a paclitaxel-coated balloon or an uncoated control balloon of similar design to the drug-coated balloon. Access function during follow-up was determined per centers' usual protocols; reintervention was clinically driven. The primary efficacy outcome assessment was done at 6 months, and the safety assessment was done within 30 days of the procedure. Prespecified secondary end points included assessment of postintervention target lesion primary patency and access circuit primary patency at 6 months.Results The 180-day end point was not met with target lesion primary patency (71%64% for the drug-coated balloon and 63%64% for control; P=0.06), representing a difference of 8%66% (95% confidence interval, 23% to 20%). Access circuit primary patency did not differ between groups. Interventions to maintain target lesion patency were fewer for the drug-coated balloon at 6 months (0.31 versus 0.44 per patient; P=0.03). The primary safety noninferiority end point was met and did not differ between groups (P=0.002).Conclusions Paclitaxel-coated balloon-assisted angioplasty did not meet the primary effectiveness end point at 180 days compared with conventional angioplasty. Both arms showed equivalent safety (ClinicalTrials.gov number NCT02440022).

Paclitaxel‐coated balloon in the treatment of recurrent dysfunctional arteriovenous access, real‐world experience and longitudinal follow up

“…At 6 months, primary target lesion patency following angioplasty with PCB was reported in previous studies to range from 44 to 97%. These findings were higher than the 6‐month circuit patency of 42.9% of all accesses reported in our study.…”

“…to prevent neointimal proliferation and decrease restenosis 11 . In the treatment of dysfunctional haemodialysis AV access, randomised controlled trials in recent years have demonstrated the superiority of PCB over plain balloon angioplasty 12,13 . In this study, which mirrors the real-world experience of using PCB in a multi-ethnic setting, we have demonstrated that treatment with PCB in patients who require more than two interventions per year has the beneficial effect of prolonging the time to the next intervention.…”

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

“…In the present longerterm analysis, TLPP at 9 months was statistically better in the DCB group (58% ± 4 vs 46% ± 4; P ¼ .02; Fig 2). Of note, whereas the TLPP at 210 days was statistically better in the 6-month analysis (29), it was not statistically so in the final analysis. ACPP did not differ between groups (Fig 3), nor did access circuit secondary patency (Fig 4).…”

Open and endovascular surgery for stenosis of the peripheral regions of arteriovenous fistula

“…В ряде случаев баллонная дилатация дополняется имплантацией стента [23,[55][56][57]. Есть подтверждения тому, что использование стентов сопряжено с большей выживаемостью сосудистого доступа по сравнению с традиционной ангиопластикой при лечении дисфункции сосудистых протезов, а также нативных АВФ [58][59][60].…”