Comparison of Bovine Carotid Artery and Expanded Polytetrafluoroethylene (ePTFE) for Permanent Hemodialysis Access

Study Overview
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Brief Summary
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The investigators did a randomized control trial comparing bovine carotid artery grafts with ePTFE grafts for patients that need hemodialysis access. The goal of the study was to determine differences in primary and assisted patency rates and frequency of complications between these two types of grafts. The investigators' hypothesis was that bovine carotid artery grafts more closely mimic autologous tissue and therefore, would provide better patency and fewer complications.

Detailed Description
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Objective: To understand how bovine carotid artery (BCA) grafts compare to cuffed polytetrafluoroethylene (ePTFE) grafts as conduits for hemodialysis access in terms of patency and complications. Background: Many hemodialysis patients do not have adequate anatomy for native arteriovenous fistulas. In these patients, synthetic conduits remain the only option for permanent hemodialysis access. We sought to compare the standard cuffed ePTFE with bovine carotid artery grafts as this has not been undertaken since the 1970's. Methods: Following Institutional Review Board approval, a prospective, randomized controlled trial was conducted enrolling 29 patients in the BCA group and 28 patients in the ePTFE group. Univariate and multivariate analysis was undertaken to understand factors that affect complications. Patency rates were calculated using the Kaplan-Meyer method.

Official Title
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Bovine Carotid Artery Graft Revisited: A Prospective, Randomized Comparison of Bovine Carotid Artery and Expanded Polytetrafluoroethylene for Permanent Hemodialysis Access

Conditions
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Kidney Failure, Renal Dialysis

Intervention / Treatment
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* Procedure: Grafts placement


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Chronic kidney disease stage 4 or 5, in need of hemodialysis access Exclusion Criteria: Surgically suitable for a native arteriovenous fistula

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Bovine Carotid Artery Graft<br> | Procedure: Grafts placement<br>* Graft placement (upper or lower extremity); surgical or radiographic revision as needed.<br>* Other names: Artegraft;|
| Active Comparator: Expanded Polytetrafluoroethylene Grafts<br> | Procedure: Grafts placement<br>* Graft placement (upper or lower extremity); surgical or radiographic revision as needed.<br>* Other names: Artegraft;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary and Assisted Patency |  | 6, 12, 18, 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| patients were monitored for the following complications: thrombosis of the graft; graft infection; pseudoaneurysm formation; steal syndrome. |  | 6,12,18 and 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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renal dialysis, bioprosthesis, arteriovenous shunt, surgical