W L Gore & Associates (Gore) has announced in a press release that the results of the REVISE clinical study showed that the Gore Viabahn endoprosthesis with Heparin Bioactive Surface is superior to percutaneous transluminal angioplasty – the current standard of care for treating stenoses or thrombotic occlusions.
The results of the Gore REVISE clinical study will be presented at the 10th Annual Scientific Meeting of the American Society of Diagnostic and Interventional Nephrology (ASDIN) in Phoenix, USA.
The multicentre, randomised-controlled trial evaluated the safety and effectiveness of the Gore Viabahn endoprosthesis in treating stenoses or thrombotic occlusions of a synthetic arteriovenous access graft at the venous anastomosis. The study compared the results of two patient groups, one treated with the Gore Viabahn device and the other receiving percutaneous transluminal angioplasty.
The press release reports the key points from the Gore REVISE clinical study as follows:
- Statistical superiority over the percutaneous transluminal angioplasty group in target lesion primary patency over a 24 month follow-up period (p = 0.008)
- Non-inferiority in terms of freedom from major device, treatment, or procedure related adverse events as compared to the percutaneous transluminal angioplasty group (p < 0.001)
- Greater primary patency for both thrombotic and non-thrombotic patients as compared to percutaneous transluminal angioplasty
- A reduction in the number of repeat interventions per patient as compared to the percutaneous transluminal angioplasty group necessary to maintain access secondary patency
- No reported fractures crossing the elbow
“The results of our study clearly demonstrate the superior clinical benefit of using a stent-graft for arteriovenous graft revisions as opposed to percutaneous transluminal angioplasty alone,” said Tom Vesely, interventional radiologist at the Vascular Access Centre, and Medical Director of the Gore REVISE clinical study. “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.”