FLAGSTAFF, Ariz. – June 28, 2016 – W. L. Gore & Associates (Gore) today announced the publication of clinical study results from the Gore REVISE Clinical Study* in the Journal of Vascular Surgery (J Vasc Surg), detailing the success of the GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface** (GORE® VIABAHN® Endoprosthesis) in AV access graft outflow interventions. Overall, the device performed significantly better compared to percutaneous transluminal angioplasty (PTA) alone for treatment of challenging AV access cases in a real-world patient population, both in terms of primary patency and in number of interventions over the study period. Notably, the Gore REVISE Clinical Study is the first AV access stent-graft study to include patients with thrombosed grafts and placement of the device across the elbow joint, further demonstrating the utility of the GORE® VIABAHN® Endoprosthesis in this demanding clinical application.
Key findings from the Gore REVISE Clinical Study:
- The device delivered a 47 percent improvement in target lesion primary patency and a 48 percent improvement in circuit primary patency over PTA alone at six months.
- The device demonstrated a 50 percent increase over PTA in target lesion primary patency at six months when treating thrombosed AV access circuits.
- When placed across the elbow, the GORE® VIABAHN® Endoprosthesis delivered 72 percent target lesion primary patency at six months and 83 percent access secondary patency at 24 months (n=22).
- The Gore REVISE Clinical Study also showed median time to target lesion reintervention or graft abandonment with GORE® VIABAHN® Endoprosthesis was approximately twice that achieved with PTA (203 versus 108 days).
- Placement of GORE® VIABAHN® Endoprosthesis led to 27 percent fewer interventions both at the target lesion and in the dialysis access circuit over a 24-month period compared to PTA.
According to the United States Renal Data System,*** there are over 700,000 patients with end-stage renal disease (ESRD) and nearly 90 percent of those patients are receiving hemodialysis. Arteriovenous grafts (AVG) are often used to create dialysis circuits for patients. Failing dialysis circuits often result in the placement of infection-prone central venous catheters (CVCs) while a new dialysis access circuit is surgically created and matured. Balloon angioplasty is a common fix in the event of a failing circuit, but many patients are unresponsive to the procedure, which has left a gap in treatment capabilities for difficult anatomies. The Gore REVISE Clinical Study demonstrated that placement of a stent-graft leads to better patient outcomes with reduced interventions, a positive finding for all stakeholders involved in the patient's care.
"Patients with failing dialysis circuits that are un-responsive to balloon angioplasty are a real problem for physicians. Historically, angioplasty has been a popular treatment option, but our study found its six-month primary patency rates to be well below the 'reasonable goal' of 50 percent stated by the 2006 K/DOQI Guidelines for Vascular Access," said Thomas Vesely, MD, an Interventional Radiologist from the Vascular Access Services in St. Louis, Mo., and the primary author of the J Vasc Surg paper. "The data shown in the Gore REVISE Clinical Study manuscript makes a compelling argument for GORE® VIABAHN® Endoprosthesis use in those challenging cases."
In 2013, the Food and Drug Administration (FDA) granted indication for the GORE® VIABAHN® Endoprosthesis to maintain and salvage failing dialysis access circuits. The Gore device is the lowest profile, most flexible, self-expanding, small-diameter, endoprosthesis available and the only stent or stent-graft to receive approval for the superficial femoral artery (SFA), in-stent restenosis of bare-metal stents in the SFA, iliac artery, and AV access. It is constructed with a durable, reinforced, biocompatible, expanded polytetrafluorethylene (ePTFE) liner and attached to an external nitinol stent structure. The GORE® VIABAHN® Endoprosthesis also features Gore's CBAS Heparin Surface, the proven, lasting heparin bonding technology designed to resist thrombus formation.
"The Gore REVISE Clinical Study was the clinical support used to gain the U.S. on-label indication for GORE® VIABAHN® Endoprosthesis in AV access," said Ray Swinney, Business Unit Leader for the Gore Peripheral Interventional Business Unit. "By expanding indications to include AV access, GORE® VIABAHN® Endoprosthesis continues to show how physicians can depend on the device for complete coverage in complex cases."
For more information about the Gore REVISE Clinical Study and the success of the GORE® VIABAHN® Endoprosthesis in AV access graft outflow interventions, the Journal of Vascular Surgery article can be viewed online at http://www.jvascsurg.org/article/S0741-5214(16)30175-6/fulltext
* Vesely T, DaVanzo W, Behrend T, Dwyer A, Aruny J. Balloon angioplasty versus Viabahn stent graft for treatment of failing or thrombosed prosthetic hemodialysis grafts. Journal of Vascular Surgery. In press.
** Heparin Bioactive Surface is synonymous with the CBAS Heparin Surface
*** Gilbertson DT, Liu J, Xue JL, Louis TA, Solid CA, Ebben JP, Collins AJ. Projecting the number of patients with end-stage renal disease in the United States to the year 2015. Journal of the American Society of Nephrology 2005;16(12):3736-3741.
Products listed may not be available in all markets. GORE® and VIABAHN® are trademarks of W. L. Gore & Associates. CBAS is a trademark of Carmeda AB, a wholly owned subsidiary of W. L. Gore & Associates, Inc.