Paclitaxel-Coated versus Plain Balloon Angioplasty for Dysfunctional Arteriovenous Fistulae: One-Year Results of a Prospective Randomized Controlled Trial

Kitrou, Panagiotis; Spiliοpoulos, Stavros; Κατσάνος, Κωνσταντίνος; Papachristou, Evangelos; Siablis, Dimitris; Karnabatidis, Dimitris

doi:10.1016/j.jvir.2014.11.003

Cited by 95 publications

(117 citation statements)

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“…Also worthy of note is that the 6-month observed patency exceeded the KDOQI recommendations in both groups. Furthermore, although the effect size is smaller than that seen in some prior trials, the 6-month target lesion primary patency in the drug-coated balloon group is very similar to that reported by Katsanos et al (8) and Kitrou et al (10), whereas the control arm patency was much lower in those studies (hence, the larger effect size). In those studies, the drug-coated balloon (which is a lower-pressure device) was used first, with further high-pressure angioplasty performed if the balloon waist was not effaced.…”

Section: Discussionsupporting

confidence: 82%

“…Although some of these therapies have shown promise, to date, no treatment modality for fistulas has been shown in a large, multicenter trial to be any better than conventional angioplasty. This study builds on smaller, randomized, single-center studies that showed benefit of the drug-coated balloon over angioplasty (7)(8)(9)(10)(11). According to the specified 180-day primary effectiveness end point, this study failed to show superiority of a paclitaxel-coated balloon over standard balloon angioplasty when applied after successful angioplasty of stenosis in fistulas.…”

Section: Discussionmentioning

confidence: 99%

“…In spite of substantial advances in our understanding of the pathophysiology of access stenosis and restenosis, there have been no large-scale studies showing superiority of any intervention for treating fistula-related stenosis. Among the most promising candidates for preventing de novo stenosis or restenosis after intervention is paclitaxel, which has proven to be beneficial in preventing restenosis in large studies in other vascular beds (4)(5)(6) and several small, randomized, single-center studies in hemodialysis access (both grafts and fistulas) (7)(8)(9)(10)(11). These studies have used specialized angioplasty balloons that have the ability to deliver the drug to the vessel wall, where it is rapidly taken up and remains in the vessel wall.…”

Section: Introductionmentioning

confidence: 99%

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Drug Coated Balloon Angioplasty in Failing AV Fistulas

Trerotola

Lawson

Roy‐Chaudhury

et al. 2018

CJASN

112

102

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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).

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Section: Discussionsupporting

confidence: 82%

Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

See 1 more Smart Citation

Drug Coated Balloon Angioplasty in Failing AV Fistulas

Trerotola

Lawson

Roy‐Chaudhury

et al. 2018

CJASN

112

102

View full text Add to dashboard Cite

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“…Paclitaxel-coated balloons (PCBs) have been tested for their safety and efficacy in the treatment of dysfunctional dialysis access in a few randomized studies and retrospective analysis of cases, with encouraging results so far (14)(15)(16)(17)(18). In two randomized controlled trials that used PCBs in arteriovenous fistulae (AVFs) and the venous outflow of arteriovenous grafts (AVGs) (14,15), the use of PCBs demonstrated significantly better results than conventional angioplasty.…”

mentioning

confidence: 99%

“…In two randomized controlled trials that used PCBs in arteriovenous fistulae (AVFs) and the venous outflow of arteriovenous grafts (AVGs) (14,15), the use of PCBs demonstrated significantly better results than conventional angioplasty. However, central venous stenoses were not treated in any of these studies.…”

mentioning

confidence: 99%