Safety and Efficacy of Paclitaxel-Eluting Balloon Angioplasty for Dysfunctional Hemodialysis Access: A randomized trial Comparing with Angioplasty Alone

Thérasse, Éric; Caty, Véronique; Gilbert, Patricia; Giroux, Marie‐France; Perreault, Pierre; Bouchard, Louis; Oliva, Vincent L.; Lespérance, Jacques; Éthier, Jean; Ouellet, Georges; Francœur, Martin; Cournoyer, Serge; Soulez, Gilles

doi:10.1016/j.jvir.2020.10.030

Cited by 18 publications

(31 citation statements)

References 19 publications

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“…22 Four larger studies, each with over 100 subjects, have been published. [23][24][25][26] These had the limitation that subjects with AVGs [23][24][25] or intravascular stents, 26 in addition to those with AVFs, were included and they had a radiological end point. Furthermore, one of these was a single centre study, 24 two excluded patients post randomisation 25,26 and two allowed more than one stenosis per patient to be included.…”

Section: Fundingmentioning

confidence: 99%

“…25,26 They gave conflicting results, with two studies suggesting a positive outcome 24,26 and the other two suggesting no benefit. 23,25 Before completion of the PAVE trial, the highest-quality evidence came from two large industry-sponsored randomised controlled trials (RCTs). 27,28 The first trial enrolled 285 patients with AVFs from 23 centres.…”

Section: Fundingmentioning

confidence: 99%

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Paclitaxel-assisted balloon angioplasty of venous stenosis in haemodialysis access: PAVE RCT

et al. 2021

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Background Reliable vascular access is essential for patients receiving haemodialysis. An arteriovenous fistula is the preferred option; however, these are prone to developing stenotic segments. These lesions are treated with angioplasty, but there is a high rate of recurrence. When the PAVE (Paclitaxel-assisted balloon Angioplasty of Venous stenosis in haEmodialysis access) trial was conceived, a number of small studies suggested that restenosis may be reduced by paclitaxel-coated balloons. Objective To test the efficacy of paclitaxel-coated balloons in arteriovenous fistulas. Design A randomised controlled trial. Setting Twenty UK centres. Participants Patients (aged ≥ 18 years) referred with a clinical indication for angioplasty of an arteriovenous fistula (212 patients in total, 106 per group). Interventions High-pressure plain balloon fistuloplasty was performed in all patients. In the intervention arm, the second component was insertion of a paclitaxel-coated balloon. In the control arm, an identical procedure was followed, but using a standard balloon. Main outcome measures The primary end point was time (days) to loss of target lesion primary patency. Secondary patency end points were time to loss of access circuit primary patency and time to loss of access circuit cumulative patency. Other secondary end points included angiographically determined late lumen loss, rate of binary angiographic restenosis, procedural success, number of thrombosis events, fistula interventions, adverse events during follow-up and patient quality of life. Results Primary analysis showed no evidence for a difference in time to end of target lesion primary patency between groups (hazard ratio 1.18, 95% confidence interval 0.78 to 1.79; p = 0.440). An adjusted secondary analysis with prespecified clinical covariates gave similar results (hazard ratio 1.11, 95% confidence interval 0.69 to 1.78; p = 0.664). Prespecified secondary outcomes included the time to intervention anywhere in the access circuit or the time until the fistula was abandoned. There were no differences in these patency-related secondary outcomes or in any other secondary outcomes, such as adverse events. Limitations The PAVE trial was not a fully blinded trial. It was impossible to ensure that treating radiologists were blinded to treatment allocation because of the appearance of the paclitaxel-coated balloon. The extent to which our findings can be generalised to patients with multiple lesions could be questioned, given the proportion randomised. However, if paclitaxel-coated balloons had been effective at a single lesion segment, then there is no plausible reason why they could not be effective in patients with multiple lesions. Conclusions There were no differences in primary or secondary outcomes. Following a plain balloon angioplasty, additional treatment with a paclitaxel-coated balloon does not provide benefit. Future work The reasons for differences between the results of the PAVE trial and of other studies deserve further analysis and consideration. Other interventions to prevent restenosis following a fistuloplasty are needed. Trial registration Current Controlled Trials ISRCTN14284759. Funding This project was funded by the Efficacy and Mechanism Evaluation programme, a Medical Research Council and National Institute for Health Research (NIHR) partnership. This will be published in full in Efficacy and Mechanism Evaluation; Vol. 8, No. 13. See the NIHR Journals Library website for further project information.

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Section: Fundingmentioning

confidence: 99%

Section: Fundingmentioning

confidence: 99%

Paclitaxel-assisted balloon angioplasty of venous stenosis in haemodialysis access: PAVE RCT

et al. 2021

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“…Eight multicentre trials 14,15,27e30,37,38 were included, with the number of centres ranging from two to 29, and six had a core lab. 15,27,30,37,38,40 All but one trial 27 reported patency results as the primary or secondary outcome. Six trials 14,15,28,30,37,38 (1 176/1 682 lesions) were sponsored by the manufacturers of the DCBs being studied.…”

Section: Literature Search and Study Selectionmentioning

confidence: 99%

“…15,27,30,37,38,40 All but one trial 27 reported patency results as the primary or secondary outcome. Six trials 14,15,28,30,37,38 (1 176/1 682 lesions) were sponsored by the manufacturers of the DCBs being studied.…”

Section: Literature Search and Study Selectionmentioning

confidence: 99%

“…Four different types of paclitaxel coated balloons were used: 11 trials used IN.PACT, 15,21e23,25e27,29,30,34,35 Lutonix 14,24 and Passeo-18 Lux 28,37 were used by two trials each, and one trial used APERTO 38 (Table 3). The trials had considerable differences regarding pre-ballooning, inflation time, procedure, and adjunctive procedures.…”

Section: Procedural Characteristics Of the Included Randomised Controlled Trialsmentioning

confidence: 99%

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Editor's Choice – Paclitaxel Coated Balloon Angioplasty vs. Plain Balloon Angioplasty for Haemodialysis Arteriovenous Access Stenosis: A Systematic Review and a Time to Event Meta-Analysis of Randomised Controlled Trials

Han

Park

Kim

et al. 2021

European Journal of Vascular and Endovascular Surgery

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The Role of Drug-Coated Balloon in Haemodialysis Arteriovenous Fistula Stenosis Management

Zhuang

Irani

Gogna

et al. 2023

Cardiovasc Intervent Radiol

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Safety and Efficacy of Paclitaxel-Eluting Balloon Angioplasty for Dysfunctional Hemodialysis Access: A randomized trial Comparing with Angioplasty Alone

Cited by 18 publications

References 19 publications

Paclitaxel-assisted balloon angioplasty of venous stenosis in haemodialysis access: PAVE RCT

Paclitaxel-assisted balloon angioplasty of venous stenosis in haemodialysis access: PAVE RCT

Editor's Choice – Paclitaxel Coated Balloon Angioplasty vs. Plain Balloon Angioplasty for Haemodialysis Arteriovenous Access Stenosis: A Systematic Review and a Time to Event Meta-Analysis of Randomised Controlled Trials

The Role of Drug-Coated Balloon in Haemodialysis Arteriovenous Fistula Stenosis Management

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