The 36-month results from the IN.PACT AV Access study (Medtronic)—which were presented for the first time during at the 2022 Charing Cross (CX) International Symposium (26–28 April, London, UK)—indicate that end-stage kidney disease (ESKD) patients treated with the IN.PACT AV drug-coated balloon (DCB; Medtronic) remained intervention-free for longer than those who received a standard percutaneous transluminal angioplasty (PTA).
Andrew Holden (Auckland City Hospital, Auckland, New Zealand) reported these findings to CX attendees during a Podium 1st presentation in the Vascular Access Masterclass session. He noted that a “significant difference” in target-lesion primary patency (TLPP) between the study’s DCB and PTA treatment groups was seen through the three-year follow-up timepoint, maintaining the trend observed in the 24-month IN.PACT AV Access data, which Holden delivered virtually at last year’s CX Symposium.
This investigational device exemption (IDE) study is seeking to assess the safety and effectiveness of the IN.PACT AV DCB, which delivers the antiproliferative drug paclitaxel to inhibit neointimal hyperplasia and treat this leading cause of arteriovenous fistula (AVF) stenosis in ESKD patients. The trial is comparing use of IN.PACT AV in a DCB group to standard PTA in a control group, and initially enrolled 330 patients with a de novo or non-stented restenotic native fistula, undergoing haemodialysis.
Building on positive results seen at previous timepoints in this prospective, single-blinded, randomised IDE study, Holden relayed a TLPP rate of 43.1% in the DCB group, compared to 28.6% in the PTA group, through 36 months. He also reported that a 21.3% reduction in reinterventions was associated with DCB use, with 255 reinterventions to maintain TLPP being required through 36 months in the DCB group versus 324 in the PTA group.
Holden then moved on to detail 36-month access circuit primary patency (ACPP) rates—stating that a “similar trend” was observed here, with a rate of 26.4% in the DCB group and 16.6% in the PTA group. He labelled this difference as being “significant” too, and noted a similar reduction (20.7%) in the number of reinterventions required to maintain ACPP within the DCB group. Some 311 reinterventions were necessary in the DCB group, compared to 392 in the PTA group.
After briefly alluding to mortality-related safety concerns that have been raised regarding paclitaxel in the past, the speaker reported an incidence of all-cause mortality—following a vital status update—that did not represent a statistically significant difference between the two treatment groups. He noted an all-cause mortality rate of 26.6% in the DCB group and 30.8% in the PTA group, and highlighted the fact that the mortality rate among “all-comer” haemodialysis patients from the United States Renal Data System (USRDS) through three years is higher than in both groups, at 41.9%.
Before concluding, Holden also referred to differences between these recent data from IN.PACT AV Access and those seen in the Lutonix AV IDE study (BD), which demonstrated TLPP rates of 26.9% and 24.4% in its DCB and PTA groups, respectively, upon concluding after 24 months. Due to its latest timepoint being at two years, Holden noted that it is difficult to draw direct comparisons between this study and IN.PACT AV Access—but stated that, having shown a sustained and superior performance with DCB verses PTA, the latter is now “the only randomised pivotal trial of a device treating dysfunctional AVFs to demonstrate consistent and sustained clinical benefit through 36 months”.
Summarising these data, he said that ESKD patients in IN.PACT AV Access had a median time to reintervention that was 14.7 months longer when they were treated with DCB compared to PTA. As such, Holden added, these findings represent durable long-term data supporting the use of the IN.PACT AV DCB as “a standard of care” for AVF maintenance in this patient population.