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Bioengineered acellular tissue engineered vessels versus autogenous fistulae for haemodialysis access: a multicentre,
Mohamad A Hussain1, Ernest E Moore2, Ruben Villa3
1Heart and Vascular Center and the Center for Surgery and Public Health, Mass General Brigham, Harvard Medical School, Boston, MA, USA.
Background:
Autogenous arteriovenous fistulas (AVFs) are considered the gold standard for haemodialysis access; however, successful fistula maturation is often not achieved. Females and patients with comorbidities such as diabetes and obesity suffer lower rates of fistula maturation, meaning many must rely on catheters or synthetic grafts for access. Therefore, we aimed to compare human acellular tissue engineered vessel (ATEV) with AVF for functional and secondary patency, as well as duration of use over 1 year in patients with end-stage kidney disease.
Methods:
In this multicentre, randomised, controlled, phase 3 trial, patients with end-stage kidney disease were recruited from 31 centres across the USA. Patients with end-stage kidney disease on haemodialysis using an indwelling catheter, who were candidates for placement of either an AVF or an arteriovenous graft, underwent screening for enrolment. Centres were selected for their ability to conduct a randomised controlled trial, and with investigators experienced in haemodialysis access procedures; site selection ensured broad generalisability across the US haemodialysis population. Patients were randomly assigned 1:1 to receive either an AVF or a ATEV for haemodialysis access via central software and database in the operating room, by study site personnel and before any initial skin incisions. The surgeon, patient, and site staff were unmasked to the allocation. The coprimary outcomes were functional patency at 6 months and secondary patency at 12 months, evaluated separately and analysed together to report global relative patency. Efficacy analyses included all randomly assigned participants and safety analyses included all participants who underwent study access creation; missing data were handled according to prespecified estimand-based methods detailed in the statistical analysis plan. This trial is registered with ClinicalTrials.gov (NCT03183245) and is now complete.
Findings:
From Sept 29, 2017, to April 22, 2023, we enrolled 242 patients. 70 (29%) patients were female, 172 (71%) were male. 119 (49%) patients were assigned to receive an autogenous AVF, and 123 (51%) patients were assigned to receive an ATEV. Superiority of the ATEV was achieved for the coprimary endpoints, with a global relative patency of 1·17 (95% CI 1·04-1·31, p=0·0090). Functional patency at 6 months was 81·3% for patients who received an ATEV and 66·4% for those who received an AVF. Secondary patency at 12 months was 67·5% for the ATEV group and 62·2% for the AVF group. Duration of usability at 1 year was 7·4 months for the ATEV group versus 6·0 months for the AVF group (95% CI for difference 0·16-2·43, p=0·025). Access infection rates between groups were similar; the ATEV group required more interventions overall compared with the AVF group. Greater benefits of ATEV were observed in female patients and in male patients who were both diabetic and obese. In this subgroup (ie, female patients and male patients with diabetes and obesity), the global relative patency was 1·66 (95% CI 1·34-2·04) in favour of ATEV.
Interpretation:
ATEV provides superior haemodialysis access outcomes at 1 year compared with AVF, with pronounced benefits observed in female patients and in male patients with obesity and diabetes.
Funding:
Humacyte.
