A drug-coated balloon yielded superior patency to percutaneous transluminal angioplasty in patients with de novo or restenotic arteriovenous fistula lesions, according to findings presented at the Cardiovascular and Interventional Radiological Society of Europe Annual Meeting.
The researchers randomly assigned 330 patients with end-stage renal disease requiring hemodialysis who had new or non-stented restenotic arteriovenous fistula lesions at 29 sites in the United States, Japan and New Zealand to receive the DCB (IN.PACT AV, Medtronic) or PTA.
“Maintaining patency and limiting the frequency of reinterventions needed to keep AV access sites functioning properly remain significant treatment challenges for physicians treating AV fistulae lesions,” presenter Andrew Holden, MD, director of interventional radiology at Auckland Hospital and associate professor of radiology at Auckland University in New Zealand, said in a press release. “These results demonstrate the promise of IN.PACT AV DCB to not only address these critical issues, but to potentially improve the quality of life of patients undergoing dialysis.”
At 6 months, the DCB group had a better rate of primary patency per Kaplan-Meier estimate compared with the PTA group (86.1% vs. 68.9%; P < .001), and this was maintained at 210 days (81.4% vs. 59%; P < .001), Holden reported at the meeting.
Reinterventions to maintain patency were 56% lower in the DCB group compared with the PTA group at 6 months, Medtronic stated in the release.
The rate of access circuit-related serious adverse events at 30 days was low and similar in both groups (DCB, 4.2%; PTA, 4.4%), and there was no difference in all-cause mortality at 6 months, according to the researchers.
The DCB is not yet approved for commercial use in the United States. – by Erik Swain
Holden A, et al. FIRST@CIRSE – First data release on endovascular research. Presented at: Cardiovascular and Interventional Radiological Society of Europe Annual Meeting; Sept. 7-11, 2019; Barcelona, Spain.
Disclosures: The study was funded by Medtronic. Holden reports he has served as a clinical investigator for studies sponsored by Arsenal Medical, Bard, Boston Scientific, Cagent Medical, Cook Medical, Endologix, Endospan, Intact Vascular, Intervene, Medtronic, Shockwave Medical, Spectranetics, TriReme Medical and W.L. Gore and Associates, but does not have any financial ties to the companies.