OBJECTIVES:

Hemodialysis patients with an arteriovenous graft (AVG) implant can experience AVG stenosis and thrombosis which require further procedural revision to maintain an open circuit for hemodialysis. This analysis aims to establish the economic value of revising an AVG with a covered stent graft compared to percutaneous balloon angioplasty (PTA) using clinical and resource use data from the Gore REVISE Clinical Study along with cost data specific to Spanish treatment setting.

METHODS:

The REVISE Study (NCT00737672) was a prospective, multicenter, RCT comparing the GORE® VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface (N=131) versus PTA (N=138) for treatment of dysfunctional or thrombosed prosthetic AVGs, following patients for two years. The trial collected resource utilization data used in this economic analysis, including number of devices used and types of repeat interventions. Procedure cost data is from the 2021 Spanish database (eSalud: Oblikue Consulting). The 2022 list prices are used for the GORE® VIABAHN® Device, prices for other stent grafts used in repeat interventions are from a 2021 Spanish Peripheral Vascular devices market report (© 2021 Decision Resource Group, Inc.).

RESULTS:

Patients in the stent graft arm incurred average total costs (ATCs) per patient of €23,838 at two years compared to €25,002 in the PTA arm, showing savings of €1,164. ATCs include index procedure costs, where stent graft patients had higher procedure and device costs compared to PTA (€3,973), but average repeat intervention costs (ARICs) over 24 months were lower than the PTA arm by €5,173, making up for the index cost difference. In patients that had thrombosed AVGs, the savings were greater: The stent graft arm had lower ATCs of €6,387.

CONCLUSIONS:

Treating dysfunctional and thrombosed AVGs with a stent graft is shown to have an economic benefit for the Spanish healthcare system compared to PTA in addition to clinical benefit as demonstrated in the REVISE Study.