Randomized Clinical Trial of Cutting Balloon Angioplasty versus High-Pressure Balloon Angioplasty in Hemodialysis Arteriovenous Fistula Stenoses Resistant to Conventional Balloon Angioplasty (original) (raw)

ABSTRACT. Balloon angioplasty (PTA) is an established treatment modality for stenosis in dysfunctional arteriovenous fistulae (AVF), although most studies showing efficacy have been retrospective, uncontrolled, and nonrandomized. In addition, it is unknown whether correction of stenosis not associated with significant hemodynamic, functional, and clinical abnormality may improve survival in AVF. This study was a prospective controlled open trial to evaluate whether prophylactic PTA of stenosis not associated with access dysfunction improves survival in native, virgin, radiocephalic forearm AVF. Sixty-two stenotic, functioning AVF,i.e., able to provide adequate dialysis, were enrolled in the study: 30 were allocated to control and 32 to PTA. End points of the study were either AVF thrombosis or surgical revision due to reduction in delivered dialysis dose. Kaplan-Meier analysis showed that PTA improved AVF functional failure-free survival rates (P= 0.012) with a fourfold increase in ...

BackgroundRestenosis 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.MethodsA 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.ResultsEleven randomized controlled trials comprised of 487 patients treated with DCB angioplasty and 489 patients treated with CB angioplasty were included. There were no significant differences in the target lesion primary patency at 6 months [RR, 0.75; 95% confidence interval (CI), 0.56, 1.01; p = 0.06] and at 12 months (RR 0.89; 95% CI, 0.79, 1.00; p = 0.06). The absence of benefit for the DCB group remained, even in the arteriovenous fistula subgroup or the subgroup of studies excluding central vein stenosis. The risk of procedure-related complication did not differ between the two groups (RR 1.00; 95% CI 0.98, 1.02; p = 0.95).ConclusionDCB angioplasty did not demonstrate significant patency benefit for the treatment of hemodialysis vascular access dysfunction. Wide variations in patency outcomes across studies were noted. Further studies focusing on specific types of access or lesions are warranted to clarify the value of DCB for hemodialysis vascular access. (PROSPERO Number CRD42019119938)

BackgroundRestenosis 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, & measurementsThis 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’ usu...

Plain old balloon angioplasty has been a common treatment for arteriovenous fistula (AVF) stenoses; but the latest clinical evidence suggests that drug coated balloons (DCB) significantly increase patency rates and reduce reintervention frequencies. DCBs delivering the antirestenotic agent paclitaxel have shown to improve outcomes by inhibiting intimal hyperplasia due to the efficient release of the drug into the vessel wall, leading to a diminished proliferation of smooth muscle cells and preventing restenosis. As such, paclitaxelcontaining balloons can improve patency rate and reduce reinterventions in hemodialysis vascular access. Evidence from clinical trials indicates that different brands of paclitaxel DCBs have different associated performance, due to specific design features, different coating technology and a various drug-ligand interactions. Besides presenting the clinical evidence of different marketed DCBs for AVF dysfunction, this review gives a further insight into the APERTO OTW (Over-The-Wire) paclitaxel DCB, and its novel SAFEPAX coating technology-specifically designed for hemodialysis vascular access stenoses. As such, this review intends to guide the interventionalist in their decisionmaking process, knowing that DCBs appear safe when used in arteriovenous access, and seem to provide a benefit in terms of increasing primary patency rates and extending the amount of time between reinterventions.