A prospective randomized study of bovine carotid artery biologic graft and expanded polytetrafluoroethylene for...

Arteriovenous grafts (AVGs) remain reliable substitutes for permanent hemodialysis access in scenarios that preclude the placement of native arteriovenous fistulas (AVFs). The majority of AVGs are constructed of expanded polytetrafluoroethylene (ePTFE), which is relatively inexpensive and readily available, but synthetic AVGs have poor patency rates. On the other hand, biologic grafts confer an advantage by virtue of their inherent similarity to the native human vasculature. However, evidence to support the current preference of synthetic conduits over biologic grafts in clinical practice is scarce. The aim of this protocol is to propose a contemporary re-evaluation and comparison between ePTFE and bovine carotid artery (BCA) grafts.

This prospective randomized controlled trial is being conducted at an academic hospital center. A total of 100 patients at least 18 years of age and undergoing AVG placement will be recruited and prospectively randomized into two parallel groups with a 1:1 allocation ratio. Patients eligible to receive AVF and those with a known allergic reaction or history of intolerance to any ePTFE or BCA component will not be included in the study. Moreover, patients with a recent active infection at the site of previous AVG placement and patients with a bleeding disorder, an active malignant disease, or a life expectancy <1 year or who refuse blood transfusion and pregnant women will be excluded. Patients will receive either BCA (experimental) or standard ePTFE grafts (control) in compliance with the National Kidney Foundation Kidney Disease Outcomes Quality Initiative guidelines for AVG creation. Primary end points include primary, primary assisted, secondary, and functional patency at 1 year and 2 years after graft placement. Secondary outcomes include complications (pseudoaneurysms, infections, and steal syndrome) and reintervention rates during the first and second postoperative years. Outcomes will be assessed and documented every 6 months.

Once the study is completed, analysis of the data will be performed using univariate methods, and Kaplan-Meier and multivariate Cox proportional regression analyses will be employed to evaluate and to compare outcomes between BCA and ePTFE over time.

The creation of a functional and durable dialysis vascular access is crucial in the treatment of patients with end-stage renal disease and is a challenging quest for vascular surgeons. The proposed study compares the outcomes of synthetic and biologic AVG options in patients who are poor candidates for a native AVF. This will help derive contemporary evidence and improve the care of vascular access patients.