PAVE 2 trial to meet need for improved evidence on drugcoated balloons

SPEAKING AT CX 2023, NARAYAN in forearm (radiocephalic) AVFs and 39.9% in upper arm (brachiocephalic and brachiobasilic) AVFs at 36 months, while the same rates with PTA were 33.8% and 21.3%, respectively. The patency advantage for DCB was significant for both forearm and upper arm fistulas.

Karunanithy (Guy’s and St Thomas’ NHS Foundation Trust, London, UK) 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.

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 sixmonth 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 been caused by differences in the choice of balloon device and drug dosage; ethnicity of participants; and proportion of prior-revascularisation patients, in each.

The authors also stratified results by lesion type, with a DCB rate of TLPP of 50.6% at 36 months for de novo lesions and 40.5% for restenotic lesions. This was statistically superior to TLPP rates for PTA which were 42.2% and 22.7%.

Lesion location

A further subgroup analysis by lesion location focused on peri-anastomotic, cephalic arch and venous outflow lesions. For peri-anastamotic lesions, IN.PACT AV had a TLPP rate of 40.4% while PTA had a rate of 31.1% at 36 months. For cephalic arch lesions, the DCB arm saw a rate of 40.9% and the PTA arm one of 27.9%, while on venous outflow lesions the former had a rate of 45.6% and the latter of 25.5%. While patency was statistically superior at all lesion locations, the most notable effect was seen in peri-anastomotic and

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

Karunanithy’s presentation was preceded by one from Ounali Jaffer (Barts Health NHS Trust, London, UK), 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 “cost- cephalic arch lesions.

For the first time, the 48-month allcause mortality results were presented which again showed no evidence of a safety concern using a paclitaxeleluting device in the AV access circuit. The mortality at 48 months was actually higher in the PTA arm at 41.8% compared to the DCB arm where mortality was 34.6% although this did not reach statistical significance.

Summarising the findings, Holden stated that they demonstrated “sustained patency benefit for IN.PACT AV DCB compared to PTA in all subgroup analyses”, and he highlighted restenoses, perianastomotic and cephalic arch lesions in particular. Concluding his talk, he said: “Durable long-term data suggest the use of IN.PACT AV DCB as a standard of care for AVF maintenance in patients with end-stage kidney disease.” effectiveness”, 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.

The CX vascular access programme—directed by Nicholas Inston (Queen Elizabeth Hospital, Birmingham, UK) and Kate Steiner (Lister Hospital, Stevenage, UK)—also hosted a number of workshops intended to provide delegates with handson education, and a chance to hone their practical skills while getting acquainted with many novel technologies. Demonstrators showcased the Ellipsys (Medtronic) and WavelinQ (BD) endovascular AVF (endoAVF) systems along with several other innovations.

Audience polling during the vascular access masterclass revealed differences of opinion on this topic. Following presentations on this subject from Alexandros Mallios (Hôpital Paris Saint-Joseph, Paris, France) and Tobias Steinke (Schoen Klinik Düsseldorf, 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 (Asklepios Klinik Barmbek, Hamburg, Germany) later in the same session.