Findings From the REVISE Study Support Gore's Viabahn Endoprosthesis for AV Access

June 28, 2016—Gore & Associates announced the publication of results from its REVISE clinical study, which evaluated the company's Viabahn endoprosthesis with heparin bioactive surface in arteriovenous (AV) access graft outflow interventions. The study was published by Thomas Vesely, MD, et al online ahead of print in the Journal of Vascular Surgery.

According to the company, the overall findings demonstrated that the device performed significantly better compared to percutaneous transluminal angioplasty (PTA) alone for the treatment of challenging AV access cases in a real-world patient population, both in terms of primary patency and in the number of interventions over the study period. The company noted that the REVISE study included patients with thrombosed grafts and placement of the device across the elbow joint, which demonstrated the utility of the device in a demanding clinical application.

The REVISE clinical study demonstrated that placement of the Viabahn endoprosthesis leads to improved patient outcomes with fewer interventions—a positive finding for all stakeholders involved in the patient’s care, stated the company.

In the study, the device demonstrated a 47% improvement in target lesion primary patency, a 48% improvement in circuit primary patency over PTA alone at 6 months, and a 50% increase in target lesion primary patency at 6 months over PTA when treating thrombosed AV access circuits.

When placed across the elbow, Viabahn showed 72% target lesion primary patency at 6 months and 83% access secondary patency at 24 months (n = 22).

Additionally, the median time to target lesion reintervention or graft abandonment with Viabahn was approximately twice that achieved with PTA (203 vs 108 days). 

Finally, placement of the Viabahn device led to 27% fewer interventions both at the target lesion and in the dialysis access circuit over a 24-month period compared to PTA.

In Gore’s announcement, Dr. Vesely commented, “Patients with failing dialysis circuits that are unresponsive to balloon angioplasty are a real problem for physicians. Historically, angioplasty has been a popular treatment option, but our study found its 6-month primary patency rates to be well below the ‘reasonable goal’ of 50% stated by the 2006 KDOQI Guidelines for Vascular Access. The data shown in the Gore REVISE clinical study manuscript makes a compelling argument for Gore Viabahn endoprosthesis use in those challenging cases.” Dr. Vesely, who is the REVISE Study Director, is an interventional radiologist with Vascular Access Services in St. Louis, Missouri.

In 2013, the US Food and Drug Administration approved the indication for the Viabahn endoprosthesis to maintain and salvage failing dialysis access circuits. Additionally, the low-profile, self-expanding Viabahn device is approved for use in the superficial femoral artery (SFA), in-stent restenosis of bare-metal stents in the SFA, iliac artery, and for AV access.