Andrew Holden (Auckland, New Zealand), one of the co-chairs of the Charing Cross (CX) International Symposium, presented the final five-year data on the vital status of patients enrolled in the IN.PACT AV Access pivotal trial in April 2024 as a podium-first presentation. Due to the paclitaxel safety concerns raised, the researchers re-consented patients enrolled in the trial to prolong the follow-up period to establish their long-term vital status.
“The all-cause mortality remains the same out to five years. There is no mortality concern using the IN.PACT [AV] drug-coated balloon (DCB). The long-term durability of this study really shows that the IN.PACT DCB should be the standard of care in maintaining [the] AV [arteriovenous] access circuit,” Holden said, reminding the audience that this is the only randomised, pivotal trial in AV access circuits to demonstrate a consistent and sustained clinical benefit out to three years.
The IN.PACT AV Access randomised controlled trial comparing plain balloon angioplasty with DCB angioplasty in managing stenotic disease in AV access has previously shown significantly improved sustained benefits for end-stage kidney disease patients at the three-year time point. Further research has also demonstrated a cost-effectiveness advantage for healthcare systems in Japan, Korea and the USA, when the device is used.
This video is sponsored by Medtronic.