A fistuloplasty balloon coated with either sirolimus or paclitaxel could keep dialysis patients’ blood vessels open for months longer than the standard uncoated balloon. Patients on haemodialysis rely on a surgically created arteriovenous fistula (AVF) to connect an artery to a vein for blood access. These fistulas often develop narrowings (stenoses) that require repeated balloon angioplasty to restore flow. Each repeat procedure carries discomfort, risk, and cost. The PAVE-2 trial will test whether drug-coated balloons—which release either sirolimus or paclitaxel into the vessel wall—delay the return of stenosis compared with plain balloons, the current NHS standard. The trial will randomise patients who have already had a successful high-pressure plain balloon fistuloplasty to one of three arms: sirolimus-coated, paclitaxel-coated, or non-coated balloon. The primary outcome is time to loss of target lesion patency, measured per lesion, with one year of follow-up. If either drug-coated balloon proves superior, it could become the new standard of care, reducing the frequency of repeat procedures for thousands of dialysis patients. This would mean fewer hospital visits, less discomfort, and lower NHS costs. The trial is the largest ever of drug-coated balloons in AVFs and aims to resolve lingering clinical uncertainty about their efficacy.
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Research Question Does either the MagicTouch sirolimus-coated balloon or the IN.PACT paclitaxel-coated balloon increase the time to the loss of target lesion primary patency in patients undergoing a plain balloon angioplasty of their arteriovenous fistula (AVF) ? Background AVFs are the best form of vascular access for haemodialysis but they have a limited survival. They frequently develop stenotic lesions which affect function. These are effectively treated with a fistuloplasty but a repeat intervention is commonly required. Therefore, there is a need to identify treatments that prolong the time to reintervention. Despite previous trials there is uncertainty amongst clinicians regarding the role of paclitaxel-coated balloons in AVFs and no robust evidence for sirolimus-coated balloons. Methods, including justification of study design We propose a randomised-controlled trial with three arms to assess the efficacy of both the MagicTouch sirolimus-coated balloon and the IN.PACT paclitaxel-coated balloon for treating AVFs. Patients who remain eligible after a successful high-pressure plain balloon fistuloplasty will be randomised 1:1:1 to the intervention and control arms. Stratification variables will include centre, type of AVF, one or more than one lesion, previous radiological intervention (yes/no), and time since the AVF was formed. Participants in the intervention arms will be treated with either the MagicTouch sirolimus-coated balloon or the IN.PACT paclitaxel-coated balloon and compared with a single control group treated with a non-coated balloon which is currently NHS standard of care. A fully blinded trial is not possible due to the differing appearances of the balloons. The only person who will be aware of the treatment allocation is the treating radiologist. The primary outcome will be time to loss of target lesion primary patency assessed per lesion rather than at the patient level. In patients with more than one lesion, all lesions will be considered as a target lesion. Secondary outcomes will include access circuit primary patency (reintervention at any lesion) and access circuit cumulative patency (AVF survival). In order to provide an outcome measure that demonstrate biological plausibility in terms of drug exposure from the eluting balloons, neointimal thickness and restenosis will be assessed by ultrasound at 3 months. Follow up in all participants will be for one year and participants will be censored if they switch to peritoneal dialysis or received a kidney transplant. The primary analysis will account for the intraclass correlation index for shared frailty due to some lesions being present in the same patient in some cases. Timelines for delivery We anticipate 6 months’ set up, 36 months recruitment, with one year follow up. With 6 months for analysis and centre closures, this is a 5 year project. Anticipated impact and dissemination This trial has the potential to change clinical practice. It will be the largest trial that has been performed of drug-coated balloons in AVFs and will provide a clear answer regarding efficacy of either paclitaxel or sirolimus-coated balloons. The results of this project will be communicated to the research community through clinical and scientific meetings. We anticipate that the results of this trial will be suitable for a high impact journal. We will communicate the study findings to patient groups locally and nationally. Our patient co-applicants will advise us on this.
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