This article is more than 5 years old. Information may no longer be current.
VIBRANT interim results: ViaBahn patency comparable to bare nitinol stent graft
More stent fractures occurred in patients receiving the bare nitinol stents.
Vascular Interventional Advances
A stent graft for the superficial femoral artery with an expanded polytetrafluoroethylene covering attached to a nitinol stent structure demonstrated similar patency to a bare nitinol stent graft, according to one-year study results.
Researchers for the multicenter VIBRANT study — designed to compare the safety and patency of the ViaBahn endoprosthesis (W.L. Gore) with a bare nitinol stent graft — enrolled 148 patients in the study and randomly assigned them to receive either the endoprosthesis or a bare nitinol stent in the superficial femoral artery. The study is designed to take place over three years, with plans to report the primary patency rate data in 2011.
The researchers reported that more than 50% of the long superficial femoral lesions treated in the study were total occlusions. No significant differences in patency between the treatment groups were reported. Freedom from target lesion revascularization was better in the group receiving the endoprosthesis (73%) vs. the bare nitinol stent (69% to 70%).
There were no differences in acute limb ischemia between the study groups (P=.14), nor were there significant differences in quality of life improvement. All patients experienced an improvement in quality of life compared with baseline, according to Gary M. Ansel, MD, director of the center for critical limb care at Riverside Methodist Hospital in Columbus, Ohio. He also reported a significant rate of stent fracture in the bare metal stent group (>30%).
“Our key finding was that treating claudicants with long diffuse disease is clinically safe and clinically effective at one year,” Ansel said at the Vascular Interventional Advances 2009 meeting in Las Vegas.
A new generation of the endoprosthesis produced after initiation of the VIBRANT trial and featuring a heparin-coated bioactive surface is currently being evaluated for safety and patency in the VIPER study. Stressing that the VIBRANT data were from an interim analysis of the ongoing trial, Ansel also noted a need for more follow-up and more complete data before drawing definitive conclusions regarding use of the endoprosthesis in patients with long superficial femoral artery disease.
“Even though the primary patencies were somewhat suboptimal, secondary patencies were much better, going along with the clinical results,” Ansel concluded. “Surveillance will be important, and [stent graft fracture] can probably be teased out over the second or third year. Longer-term follow-up will be important.” – by Eric Raible
For more information:
- Ansel G. Interim results of the VIBRANT trial. Presented at: Vascular Interventional Advances; Oct. 20-23, 2009; Las Vegas.