Bioengineered vessels beat fistulae for haemodialysis access: a phase 3 trial | TheLancet

https://www.thelancet.com/journals/landig/article/PIIS2589-7500(26)00059-2/fulltext

This post is intended for those in the healthcare field. This article is interesting because:

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.

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.

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