Efficacy of Paclitaxel Balloon for Hemodialysis Stenosis Fistulae After One Year Compared to High-Pressure Balloons: A Controlled, Multicenter, Randomized Trial

Sánchez, T. Moreno; Moreno‐Ramirez, Manuela; Machancoses, Francisco Herrero; Pardo-Moreno, P.; Navarro-Vergara, P F; García-Revillo, J.

doi:10.1007/s00270-019-02372-w

Cited by 27 publications

(49 citation statements)

References 35 publications

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“…After reviewing the titles and abstracts, 999 publications were excluded. After reviewing the full text of 20 publications, 11 publications were included in the final qualitative and quantitative analyses, with a total of 976 patients [8][9][10][11][12][13][14][15][16][17][18]. The flow diagram of the systematic search process is depicted in…”

Section: Study Selectionsmentioning

confidence: 99%

Drug-coated balloon versus conventional balloon angioplasty of hemodialysis arteriovenous fistula or graft: A systematic review and meta-analysis of randomized controlled trials

et al. 2020

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Background Restenosis 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. Methods A 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. Results Eleven randomized controlled trials comprised of 487 patients treated with DCB angioplasty and 489 patients treated with CB angioplasty were included. There were no significant

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Section: Study Selectionsmentioning

confidence: 99%

Drug-coated balloon versus conventional balloon angioplasty of hemodialysis arteriovenous fistula or graft: A systematic review and meta-analysis of randomized controlled trials

et al. 2020

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“…Six-month death rates are comparable to the only currently availble meta-analysis by Dinh et al (20) (5.2%). Moreno-Sanchez et al (21) presented a mortality rate of 5.7% at 1 year, while Lucev et al (22) and Trerotola et al (17) a 12.9% and a 23% mortality rate at 2 years, respectively. With death rates of dialysis patients reaching 34.1% according to a meta-analysis by Siga et al (23) and 33% based on the United States Renal Data System (24) at 2 years, one can understand that the ability of a procedure or device, as in the case of DCBs, to provide uninterrupted hemodialysis to these patients has a high impact in their quality of life.…”

Section: Discussionmentioning

confidence: 95%

A Multicenter Global Registry of Paclitaxel Drug-Coated Balloon in Dysfunctional Arteriovenous Fistulae and Grafts: 6-Month Results

Karnabatidis

Kitrou

Ponce³

et al. 2021

Journal of Vascular and Interventional Radiology

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To assess the safety and clinical benefit of the Lutonix drug-coated balloon (DCB) catheter for the treatment of dysfunctional arteriovenous fistulae (AVF) and grafts (AVG) in a heterogenous real-world population.Materials and Methods: This multicenter, prospective study enrolled 320 subjects from 12 countries in 25 sites across Europe and Asia. A total of 392 lesions were treated with the Lutonix 035 DCB catheter. Lesions were de novo and restenotic, located in every part of the circuit from the cannulation zone to central venous outflow. In-stent restenotic lesions also were treated. The primary safety endpoint was freedom from serious adverse events involving the access circuit through 30 days. The primary effectiveness endpoint was target lesion primary patency (TLPP) through 6 months. Secondary endpoints included access circuit primary patency (ACPP) at 6 months and the investigation of factors that would independently influence the primary endpoints.Results: The primary safety endpoint was 95.5%, while TLPP was 73.9% at 6 months, per Kaplan-Meier survival analysis. ACPP was 71% at 6 months. TLPP for stenosis of AVFs was 78.1%. Subgroup analysis showed significantly improved TLPP when DCB was dilated for 120 seconds (P ¼ .007). TLPP was significantly better when predilation occurred compared with cases where only DCB angioplasty was performed (77% vs 48.6%, P ¼ .0005). Conclusions:The Lutonix AV Global Registry confirms that the Lutonix DCB is a safe and effective treatment option in real-world patients with dysfunctional AVF or AVG. Procedural details had a significant role in TLPP. No significant difference in TLPP was observed among different treatment areas. ABBREVIATIONSAVG ¼ arteriovenous graft, AVF ¼ arteriovenous fistula, DCB ¼ drug-coated balloon, TLPP ¼ target lesion primary patency Vascular access (VA) stenosis in arteriovenous fistulae (AVFs) and arteriovenous grafts (AVGs) constitutes one of the main reasons for their dysfunction (1). According to the latest Kidney Disease Outcomes Quality Initiative clinical practice guidelines for VA, it is considered reasonable to use high-pressure balloon angioplasty as From the Interventional Radiology Department (D.

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“…The aim of the PAVE trial was to assess the efficacy of paclitaxel-coated balloons in the treatment of AVFs used to deliver hemodialysis. Although a number of earlier studies have suggested a possible benefit, [13][14][15][16][17][18][19] there are only 2 previous large randomized trials, with clinical endpoints, addressing this question. 20,22 The first published large-scale trial by Trerotola et al, using the same paclitaxel-coated balloon as the current trial, also failed to demonstrate a difference between arms in their prespecified primary endpoint, TLPP at 180 days, 20 but there was a significant difference at 210 days in an exploratory analysis.…”

Section: Discussionmentioning

confidence: 99%

“…One of these included 148 lesions and had an angiographic rather than clinical primary endpoint. 18 The other randomized 132 lesions and had an ultrasonographic endpoint. 19 In this second study, 48% of lesions contained an endovascular stent, which complicates interpretation of the results.…”

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confidence: 99%

A multicenter randomized controlled trial indicates that paclitaxel-coated balloons provide no benefit for arteriovenous fistulas

Karunanithy

Robinson

Ahmad

et al. 2021

Kidney International

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Efficacy of Paclitaxel Balloon for Hemodialysis Stenosis Fistulae After One Year Compared to High-Pressure Balloons: A Controlled, Multicenter, Randomized Trial

Cited by 27 publications

References 35 publications

Drug-coated balloon versus conventional balloon angioplasty of hemodialysis arteriovenous fistula or graft: A systematic review and meta-analysis of randomized controlled trials

Drug-coated balloon versus conventional balloon angioplasty of hemodialysis arteriovenous fistula or graft: A systematic review and meta-analysis of randomized controlled trials

A Multicenter Global Registry of Paclitaxel Drug-Coated Balloon in Dysfunctional Arteriovenous Fistulae and Grafts: 6-Month Results

A multicenter randomized controlled trial indicates that paclitaxel-coated balloons provide no benefit for arteriovenous fistulas

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