PAVE-2, paclitaxel and sirolimus-coated balloons for AVF

The range of options in drug-coated balloons (DCBs) for stenosis in arteriovenous fistulas (AVFs) demand comprehensive exploration. The PAVE-2 trial comes as the latest in a series of studies intended to assess the evidence and illuminate the space. By Michael

Robson and Narayan Karunanithy (King’s College London, London, UK)

Plain balloon fistuloplasty is an effective treatment for a dysfunctional arteriovenous fistula. However, restenosis is common, leading to a need for repeat intervention. To reduce this need, drug-coated balloons have been extensively studied to determine if they prolong the time to retinervention and provide benefit. The PAVE-2 trial, which promises to further illuminate the subject by assessing two types of DCB, will come as the latest in a line of trials exploring their efficacy.

Paclitaxel-coated balloons allow local delivery of paclitaxel to the site of stenosis. Paclitaxel is a drug which inhibits the cellular proliferation that leads to restenosis following fistuloplasty. Since 2015, there have been many studies published assessing their effectiveness in preserving patency following angioplasty of an AVF. There have been several systematic reviews and the general conclusion has been that there is no overall evidence of an effect for paclitaxel-coated balloons on target lesion primary patency rates. Many of the studies included in these meta-analyses had small sample sizes and there was considerable heterogeneity. There have been three multicentre, randomised controlled trials (RCTs) with more than 200 participants , which is significantly more participants than other studies, and it is useful to consider these in more detail.

The first was from Scott O Trerotola (Hospital of the University of Pennsylvania, Philadelphia, USA) et al with 285 participants and had a primary endpoint of target lesion patency at six months. There was no significant difference between groups treated with a paclitaxel-coated balloon compared with a control group receiving treatment with a non-coated balloon.1 A second study by Robert A Lookstein (Ichan School of Medicine at Mount Sinai, New York City, USA) et al with 330 participants, using the same binary primary endpoint but a different paclitaxel-coated balloon, did find a difference between groups.2

However, the National Institute for Health and Care Research (NIHR) funded the investigator-led Paclitaxel-assisted balloon angioplasty of venous stenosis in haemodialysis access (PAVE) trial with 212 participants, which failed to show an effect on time to end of target lesion primary patency after treatment with the Lutonix (BD) paclitaxel-coated balloon compared with a non-coated balloon. 3

The reason that the PAVE trial and the study by Trerotola et al did not show a benefit whereas the study by Lookstein et al did is not entirely clear. If the PAVE trial and the IN.PACT AV study are considered, there were differences in patient demography. In the PAVE