Abstract: SA-OR95
Prospective Randomized Trial of Humacyte's Acellular Tissue Engineered Vessel vs. Autologous Arteriovenous Fistula for Hemodialysis Access
Session Information
- High-Impact Clinical Trials - 2
October 26, 2024 | Location: Hall D, Convention Center
Abstract Time: 11:45 AM - 12:00 PM
Category: Dialysis
- 803 Dialysis: Vascular Access
Authors
- Hussain, Mohamad Anas, Brigham and Women's Hospital, Boston, Massachusetts, United States
- Ozaki, Charles Keith, Brigham and Women's Hospital, Boston, Massachusetts, United States
- Moore, Ernest E., Denver Health Main Campus, Denver, Colorado, United States
- Khondker, Zakaria, Humacyte Global Inc, Durham, North Carolina, United States
- Parikh, Shamik J, Humacyte Global Inc, Durham, North Carolina, United States
- Niklason, Laura E., Humacyte Global Inc, Durham, North Carolina, United States
Background
Arteriovenous fistulas (AVFs) are a preferred method for initial vascular access in patients requiring hemodialysis (HD). Failure of AVF maturation can drive increased catheter use and associated increased morbidity/mortality. An alternative vascular access option that offers the benefits of AVFs, including a low infection rate, without the associated maturation failure, is needed.
Methods
We conducted a phase 3, prospective, multicenter, two-arm, randomized controlled trial in 242 subjects with HD undergoing surgical vascular access creation. Receipt of the Acellular Tissue Engineered Vessel (ATEV) or autologous AVF was randomized. Co-primary outcomes were 6-month functional patency and 12-month secondary patency after access creation. Secondary outcomes included comparisons of access usability and infection rates.
Results
Mean participant age was 58.6 years; 29% were female. ATEV recipients had higher rates of 6-month functional patency (81% vs 68% for AVF) and 12-month secondary patency (68% vs 62% for AVF) (p=0.0071; joint test for co-primary endpoints). Mean duration of ATEV use was also significantly higher than AVF (7.5 vs 6.1 months, p=0.0162). Female ATEV subjects experienced higher rates of 6-month functional patency (89% vs. 55% for AVF) and 12-month secondary patency (81% vs. 49% for AVF) (p<0.0001; joint test). Access-related infection rates were comparable (ATEV 5.8% vs AVF 4.1%). No unexpected safety events were observed.
Conclusion
Humacyte ATEV had better access functional patency and usability versus AVFs at one year. Female subjects experienced improved outcomes, supporting ATEV consideration as a novel access option for subjects at high risk for AVF non-maturation. (CLN-PRO-V007; ClinicalTrials.gov, NCT03183245).
Co-primary Endpoints.
| Overall Subjects | |||
| ATEV (n=123) | AVF (n=119) | p-value | |
| Functional Patency 6 months | 81.3% (100) | 66.4% (79) | 0.0071 |
| Secondary Patency 12 months | 68.3% (84) | 62.2% (74) | |
| Duration of Usability 12 months | 7.5 months (SD=4.2) | 6.1 months (SD=4.5) | 0.0162 |
| Female Subjects | |||
| ATEV (n=37) | AVF (n=33) | p-value | |
| Functional Patency 6 months | 89.2% (33) | 54.5% (18) | <0.0001 |
| Secondary Patency 12 months | 81.1% (30) | 48.5% (16) | |
SD: standard deviation
Funding
- Commercial Support – Humacyte Global, Inc.