The Zilver PTX Stent: 3-Year Trial Results and FDA Approval

At the 2012 VEITHsymposium, investigators from the Zilver PTX trial presented 3-year results from the study. The study of the Cook Medical stent was the largest ever randomized trial for endovascular treatment of superficial femoral arterydisease with an endovascular device. Vascular Disease Management spoke with Michael Dake, MD, co-principal investigator of the study, about the results. One- and 2-year results had been presented previously, and these longer-term results were presented to show clinicians that the drug on the stent does not cause late phenomenon that limits its effectiveness. There were 479 patients, and patency was judged by ultrasound criteria. Dr. Dake explained that the results clearly show a significant difference for patency of the Zilver PTX stent vs a bare metal stent.

Michael Dake, MDDr. Dake is a professor of cardiothoracic surgery at Stanford University and director of the Catheterization and Angiography Laboratory at Stanford University Medical Center. His research focuses on endovascular device development and management of aortic pathologies. He is a major contributor to the development of vascular stent-grafting and image-guided treatments for arterial disease and venous disease. See video from the interview with Dr. Dake recorded at VEITHsymposium.

Gary Ansel, MDAfter the conclusion of the VEITHsymposium meeting, VDM also spoke with Dr. Dake’s co-principal investigator for the trial, Gary Ansel, MD, about the study results and the FDA approval of the stent, which occurred at the same time as the VEITHsymposium meeting was being held. Dr. Ansel pointed out that the need for repeat procedures was much lower than in previous trials. He also noted that the pattern of restenosis was less diffuse than typical bare metal stent restenosis and that diabetic patients did not seem to have a higher restenosis rate than nondiabetics, which he felt was an exciting result of the trial.

Dr. Ansel is the director for the Critical Limb Care Center at Riverside Methodist Hospital in Columbus, Ohio, and Assistant Clinical Professor of Medicine in the department of internal medicine at the University of Toledo Medical Center (formerly Medical College of Ohio). Read the Q&A interview with Dr. Ansel about the Zilver PTX stent.

 

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