SS17 - Acellular Tissue Engineered Vessel Outperforms Arteriovenous Fistula in High-Risk Patients on Hemodialysis: Results from the CLN-PRO-V007 Randomized Controlled Trial

Objectives: CLN-PRO-V007 is a phase 3 clinical trial that compared the efficacy and safety of Humacyte’s Acellular Tissue Engineered Vessel (ATEV) with autologous arteriovenous fistulas (AVFs) in patients with end-stage kidney disease (ESKD) on hemodialysis (HD). The overall trial showed superiority of ATEV over AVF with relatively low infection rates, though performance of ATEV in high-risk patients remains uncertain. This planned secondary analysis focuses on outcomes of ATEV versus AVF in high-risk subgroups of ESKD patients.

Methods: CLN-PRO-V007 is a prospective, multicenter, two-arm, randomized controlled trial in ESKD patients on HD undergoing single-stage surgical vascular access creation. Subjects were randomized 1:1 to receive an ATEV or AVF. In this post hoc analysis, high-risk ESKD patients were defined as 1) females, and 2) males with body mass index (BMI) ≥ 30 kg/m2 and diabetes. Outcomes included 6-month functional patency, 12-month secondary patency, duration of access usability, and adverse events.

Results: A total of 110 high-risk ESKD patients were included (56 ATEV: 54 AVF), out of 242 patients enrolled. Functional patency at 6 months and secondary patency at 12 months were significantly higher in ATEV recipients (78.9% and 68.4%, respectively), compared with AVF (47.6% and 42.9%, respectively) (global p-value, p=0.0083). Duration of access usability over the first year trended higher in the ATEV group (7.5 months vs. 3.7 months for AVF; p=0.0563). These results were consistent across individual subgroups of female patients and male patients with BMI ≥ 30 kg/m2 and diabetes (Table I). Safety analyses demonstrated similar rates of serious adverse events (SAEs) for ATEV patients (4.2 per patient-year of usability [PYU]) and AVF patients (6.1 per PYU). After adjustment for PYU, adverse events of special interest were also similar between ATEV (4.8 per PYU) and AVF (4.2 per PYU). Infection rates were comparable between ATEV and AVF, both in the individual subgroups and in the combined all female and male patients with BMI ≥ 30 kg/m2 and diabetes. At 12 months in the combined population, the rates of HD-related (included catheters) infection and study access-related infection for ATEV were 14.8% and 7.4%, respectively. For AVF, infection rates were 8.9% and 5.4%, respectively.

Conclusions: ATEV provides better functional patency, usability, and a comparable access-related complication profile to AVFs in high-risk subgroups of ESKD patients. This makes ATEV a promising alternative for vulnerable populations requiring HD access and highlights its potential to address unmet needs in patients with complex clinical profiles. (CLN-PRO-V007; ClinicalTrials.gov, NCT03183245).