IN.PACT AV three-year subanalysis trial data show “durable” long-term results

At the 2023 Charing Cross (CX) International Symposium (25–27 April, London, UK), Andrew Holden (Auckland City Hospital, Auckland, New Zealand) presented new data from the IN.PACT AV Access trial of the IN.PACT AV (Medtronic) drug-coated balloon (DCB). Offering three-year subanalysis data, he said that the study is “the only randomised pivotal trial of a device treating dysfunctional arteriovenous fistulas (AVFs) to demonstrate consistent and sustained clinical benefit” up to three years.

Establishing some background to the study, Holden noted that there have been eight published peer-reviewed studies with outcomes reported through to three years, but he said that all of these were single-centre with no adjudication—and that “all except one were single-arm and retrospective”. That means there is, in his words, “a paucity of evidence of long-term outcomes after treatment of stenoses in AV access”.

The IN.PACT AV study was initially planned to extend to 24 months, and a five-year extension meant a shrinking of the pool of participants as a result of death, withdrawal and declined consent to further study. In total, 133 participants completed their threeyear visit out of an original cohort of 330 patients receiving the index procedure. Of that 330, 170 were in the

IN.PACT AV arm, while 160 received percutaneous transluminal angioplasty (PTA). In the IN.PACT AV arm, the mean age was 65.8 years and 112 of 170 were male. The standard PTA arm had a mean age of 65.5 and 101/160 were male.

As presented at CX 2022 (26–28 April, London, UK), at 36 months, the DCB arm yielded a target lesion primary patency (TLPP) rate of 43.1% while the PTA arm had a rate of 28.6%, a statistically significant patency advantage for the DCB. This year, Holden set out for the first time the results of subgroup analyses in patients receiving an AVF in the forearm and upper arm at three years.

Those analyses included one in which the results were stratified by AVF type. In that analysis, the IN.PACT AV arm had a patency rate of 44.5%