PAVE 2 trial to meet need for improved evidence on drug-coated balloons

Speaking at yesterday’s CX vascular access masterclass session, Narayan Karunanithy (London, United Kingdom) set out “the need for more evidence” as part of a presentation on the upcoming, National Institute for Health and Care Research (NIHR)-funded, investigator-initiated PAVE 2 trial providing a comparison between multiple drug-coated balloons (DCBs) and plain-balloon angioplasty for the treatment of dysfunctional arteriovenous fistulas (AVFs) in dialysis patients.

THE VASCULAR ACCESS programme—directed by CX executive board members Nicholas Inston (Birmingham, United Kingdom) and Kate Steiner (Stevenage, United Kingdom)—also hosted a number of workshops intended to provide delegates with hands-on education, and a chance to hone their practical skills while getting acquainted with many novel technologies. Demonstrators including Gavin Corrigan (Dublin, Ireland), John McCafferty and Daniela Romero (both Edinburgh, United Kingdom) showcased the Ellipsys (Medtronic) and WavelinQ (BD) endovascular AVF (endoAVF) systems along with several other innovations.

In his presentation, Karunanithy noted that, while plain-balloon fistuloplasty continues to be the “mainstay” in dysfunctional AVF treatments, its benefits may only be short-term— with reported six-month primary patency rates of 60–70% decreasing to 40–50% at 12 months. Reviewing the published literature on paclitaxel-coated balloon use, the speaker reflected that discrepancies between the findings of multiple studies in this space may have and to treat the culprit lesion. Though there are a range of techniques available, there are no randomised controlled trials to guide choice of technique. While there have been meta-analyses performed, Gibson argued that there is “no clear winner” on the issue. This is where real-world considerations could help to expedite a decision. been caused by differences in the choice of balloon device and drug dosage; ethnicity of participants; and proportion of prior-revascularisation patients, in each.

In the real world, he said, clinical decision-making during the COVID-19 pandemic changed to favour methods that were both the least invasive and most likely to be successful—as well as less resourceintensive. He noted that this had led to a fall in declotting procedures, especially surgical declotting, per a report on access management during the pandemic published in the Journal of Vascular Access by Christopher Seet (London, United Kingdom) et al in 2021. Gibson’s concluding message was to “treat [thrombosis] quickly and effectively, but be realistic and think of the future”. He added that technique is “less important than availability, skill and enthusiasm”.

Also presenting was Georgia Georgopoulou (Patras, Greece), who detailed the Nephrology Partnership for Advancing Technology in Healthcare (N-PATH) interventional nephrology training programme. She described it as “the first European advanced training course in diagnostic and interventional nephrology”, explaining that it comprises component modules in molecular pathology, vascular access, medical ultrasound and peritoneal dialysis, each with handson training sessions in cities across Europe including Milan and Prague, while also including online educational resources.

Next, Karunanithy discussed emerging evidence evaluating the role of sirolimus-coated balloons, such as the MATILDA study of the MagicTouch (Concept Medical) device, which has reported target-lesion primary patency (TLPP) rates of 83% at six months and 58% at 12 months, and the ISABELLA study of the Selution DCB (MedAlliance), which found TLPP rates of 72% at six months and 44% at 12 months. Further evidence on the MagicTouch balloon is awaited from the ongoing IMPRESSION randomised controlled trial, he added.

Finally, the speaker announced plans for the upcoming PAVE 2 trial—the primary objective of which will be to evaluate and compare the efficacy of the paclitaxel-based IN.PACT AV DCB (Medtronic), the aforementioned MagicTouch DCB, and plainballoon angioplasty treatments.

According to Karunanithy, this three-arm study aims to recruit 642 patients across approximately 20 high-volume haemodialysis centres in the United Kingdom, and is scheduled to commence recruitment in Autumn 2023.

Karunanithy’s presentation was preceded by one from Ounali Jaffer (London, United Kingdom), who took the opposing stance of querying: Is there “too much evidence” on DCBs? He called into question the impact patient factors may have had in contrasting trial results to date; emphasised the difference between “efficacy” and “costeffectiveness”, and the need for greater uniformity of trial designs; and noted that artificial intelligence may have a key role to play if global database analyses are embraced in the future.

Audience polling during the vascular access masterclass revealed differences of opinion on another hot topic in dialysis access: endoAVFs. Following presentations on this subject from Alexandros Mallios (Paris, France) and Tobias Steinke (Düsseldorf, Germany), among others, 59% of attendees voted against the motion that “endovascular AVFs are the way forward”, while 41% voted in favour. The topic of endoAVFs was also the focus of an edited case delivered by Robert Shahverdyan (Hamburg, Germany) later in the