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Peripheral Intervention
November 6th, 2018

Zilver® PTX® global data analysis reveals proven long-term benefit, real-world outcomes


Zilver® PTX® global data analysis reveals proven long-term benefit, real-world outcomes1

On Nov. 6, Dr. Michael Dake, senior vice president for University of Arizona Health Sciences, presented results from a global data analysis on Zilver PTX at VIVA (Vascular InterVentional Advances). The conference, which has been held for the past 16 years in Las Vegas, attracts world-renowned vascular intervention specialists.

The global data analysis on the world’s first drug-eluting stent in the superficial femoral artery (SFA) included nearly 2,400 patients from 16 countries who participated in one of five Zilver PTX studies. These include three pre-market studies in North America, Asia, and Europe and two post-market studies in the United States and Japan.

Overall, the real-world patient population had an elevated rate of diabetes (49%), occluded vessels (36%), and longer lesion lengths (11.1 ± 8.7 cm).

Dr. Dake’s analysis showed that patients treated with Zilver PTX had a 91% one-year freedom from target lesion revascularization (TLR) rate. Surprisingly, there was no significant impact on TLR due to Rutherford score, gender, calcification, and diabetes.

“Patient characteristics, including Rutherford score, gender, calcification, and diabetes typically affect TLR rates. In this global analysis of Zilver PTX patients, these characteristics did not have a significant impact on TLR,” Dr. Dake said.

Even considering factors that normally lead to a higher rate of TLR, such as long lesions, reference vessel diameter of less than 5 mm, and chronic total occlusions, Zilver PTX still had positive outcomes.

With up to five years of data from these studies, Zilver PTX has shown proven long-term benefits in real-world outcomes, said Dr. Dake, who served as primary investigator in the Zilver PTX randomized controlled trial (RCT).

The Zilver PTX RCT is the longest-running DES trial for treating peripheral artery disease in the SFA2. “This first-of-its-kind study showed that, after five years, Zilver PTX has sustained benefit compared to standard of care with 84.9% freedom from TLR and a 72.4% primary patency rate,” Dr. Dake said.

  1. Dake MD. Zilver PTX global data analysis highlights DES benefits in challenging patient populations. Presented at: Vascular Interventional Advances (VIVA), Nov. 6, 2018; Las Vegas, NV.
  2. Dake MD, Ansel GM, Jaff MR, et al. Durable clinical effectiveness with paclitaxel-eluting stents in the femoropopliteal artery: 5-year results of the Zilver PTX randomized trial. Circulation. 2016;133(15):1472-83.

Dr. Dake is a paid consultant for Cook Medical.

PI-D45769-EN