Bioengineered Vessel Adds 91 Catheter-Free Days for Women on Dialysis

Among women with end-stage kidney disease (ESKD), who face lower fistula maturation rates than men, an acellular tissue engineered vessel (ATEV) significantly increased catheter-free days over 12 months compared with an arteriovenous fistula (AVF) in the randomized phase 3 V012 trial.¹

Presented at the American Society of Nephrology (ASN) Kidney Week 2026 in Denver, Colorado, by Prabir Roy-Chaudhury, MD, PhD, FASN, co-director of the University of North Carolina (UNC) Kidney Center at the UNC at Chapel Hill School of Medicine, the interim data show women who received the ATEV reached functional access months sooner and had fewer dialysis access-related infections. Investigators concluded the findings support the ATEV as a potential first-line option for women at increased risk of AVF maturation failure.

“Vascular access really is currently both the lifeline for patients on hemodialysis, but it’s also the Achilles heel,” Roy-Chaudhury said in an interview with HCPLive. “If you place 100 arteriovenous fistulae, you’re only going to get about 40 or 45 of them that will work well to support dialysis without intervention.”

AVFs are the preferred access for hemodialysis, but delayed or failed maturation often prolongs central venous catheter use.¹ Catheters carry well-documented risks, including bloodstream infection, thrombosis, and central venous stenosis.² Women experience lower AVF maturation and greater catheter dependence than men, which contributes to morbidity in this population.¹

Catheter Dependence in Women Drove the V012 Trial

Roy-Chaudhury put infection at the top of that list, summarizing the complications of prolonged tunneled catheter use as “number one infection, number two infection, number three infection.”

He noted that vascular access research has not previously studied women as a high-risk group. Investigators described V012 as the first randomized evaluation of a vascular access conduit in this population.¹

V012 Randomized Women With ESKD to ATEV or AVF

V012 is a prospective, multicenter, randomized phase 3 trial enrolling women with ESKD who were receiving hemodialysis via catheter and were eligible for AVF creation. Patients were randomized in a 1:1 ratio to receive an ATEV or an AVF.¹

The primary endpoint was catheter-free days through 12 months. Investigators performed a prespecified interim superiority analysis after 80 patients, 40 in each group, completed 12 months of follow-up.¹

ATEV Increased Catheter-Free Days and Shortened Time to Maturation

The ATEV met the primary endpoint, with a mean of 220 catheter-free days over 12 months vs 129 days with AVF (difference, 91 days; 95% CI, 40–142; P < .001). At 6 months, the ATEV group had 52 additional catheter-free days (P < .0001).¹

Functional patency over 12 months was greater with the ATEV (250 vs 152 days; P < .001), and mean time to maturation was 1.7 months vs 5.3 months with AVF. Secondary patency was greater with the ATEV at 6 months (88% vs 65%; P = .02). At 12 months, it was 78% vs 63%, a difference that was not statistically significant (P = .16).¹

Thrombosis, Stenosis, and Infection Outcomes With ATEV

Dialysis access-related infections, including catheter infections, occurred in 15% of patients in the AVF group vs 5.1% in the ATEV group. No study access-related infections occurred in either group. True or pseudoaneurysm and steal syndrome were infrequent, and no study access ruptures were observed.¹

Thrombosis and stenosis events were more frequent with the ATEV (20 and 43 events vs 8 and 36 with AVF, respectively). However, the usage-adjusted stenosis rate was lower with the ATEV, at 162 vs 229 per 100 patient-years.¹

Roy-Chaudhury explained that because ATEVs matured faster, they were in use for about 3 months longer during the first year, and event rates were more comparable after accounting for that additional time. “But again, I think this is something that needs to be looked at in more detail,” he said.

Editors’ Note: Disclosures for Roy-Chaudhury include Adgero, Alexion, AstraZeneca, Bayer, Becton Dickinson, BioMed Organ Bank, Boston Scientific, CorMedix, Cylerus, Eko, Humacyte, Inovasc, Merit Medical, Mozarc, Panoramic Health, Sojourn, and Vera Therapeutics.

References

1. Hussain MA, Roy-Chaudhury P, Bou-Ghannam S, et al. Randomized controlled trial of an acellular tissue engineered vessel vs. arteriovenous fistula for hemodialysis access in female patients with ESKD: a phase 3 CLN-PRO-V012 interim analysis. Abstract presented at: American Society of Nephrology Kidney Week 2026; October 21–25, 2026; Denver, CO. Abstract TH-OR113. doi:10.1681/ASN.2026q87550d8

2. Lok CE, Huber TS, Lee T, et al. KDOQI clinical practice guideline for vascular access: 2019 update. Am J Kidney Dis. 2020;75(4 Suppl 2):S1-S164. doi:10.1053/j.ajkd.2019.12.001