Gore's REVISE Study Shows Superiority of Viabahn Over PTA for AV Access

February 19, 2014—Gore & Associates (Flagstaff, AZ) announced results of the REVISE study, a multicenter, randomized controlled trial evaluating the safety and efficacy of the company’s Viabahn endoprosthesis in stenotic and thrombotic occlusions in arteriovenous (AV) access patients.

The study compared results of patients treated with the Viabahn device against those treated with percutaneous transluminal angioplasty (PTA). Data demonstrated statistical superiority in the Viabahn group in target lesion primary patency over 24-month follow-up (P = .008). The Viabahn group also demonstrated noninferiority in terms of freedom from major device-, treatment-, or procedure-related adverse events as compared to the PTA group (P < .001), as well as greater primary patency for both thrombotic and nonthrombotic patients. There was a reduction in the number of repeat interventions per patient as compared to the PTA group to maintain secondary patency of vascular access grafts. There were no reported device fractures crossing the elbow.

“The results of our study clearly demonstrate the superior clinical benefit of using a stent graft for AV graft revisions as opposed to PTA alone,” said Thomas Vesely, MD, interventional radiologist at the Vascular Access Center in Frontenac Grove, Missouri, and Medical Director of the Gore REVISE study, in the company’s press release. “In addition to its proven clinical benefit, the Gore Viabahn endoprosthesis is both flexible and durable, allowing it to conform to the anatomy of a moving arm and cover every curve. The device provides physicians with an endovascular tool to treat even the most challenging venous anastomotic locations.”

According to the company, the Viabahn device is a low-profile, flexible, self-expanding endoprosthesis approved for use in the superficial femoral and iliac arteries and AV access. It is constructed with an expanded polytetrafluoroethylene liner and is attached to an external nitinol stent structure. The luminal surface features the company's Carmeda bioactive heparin surface to help sustain antithrombotic bioactivity.