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Peripheral Intervention
April 16th, 2019

Zilver® PTX®: Transparency, data, and patient safety


Paclitaxel
Recently, there has been a lot of important discussion surrounding the use of paclitaxel-coated devices to treat peripheral arterial disease. In early March 2019 the FDA issued an updated letter outlining current recommendations to health care providers who are making treatment decisions about paclitaxel devices. In the spirit of full transparency, Cook Medical is providing our extensive long-term data on Zilver PTX, our drug eluting stent. Zilver PTX is a paclitaxel-coated stent that was approved by the FDA in 2012 through the premarket approval process.The industry-wide discussion and the FDA letter is in response to a meta-analysis published in the Journal of the American Heart Association regarding mortality rates related to the use of paclitaxel-coated stents and balloons. The meta-analysis includes Zilver PTX. We share the same concern for patient safety and support the development of peer-reviewed literature that discusses devices used to treat patients suffering from PAD. We also believe that to appropriately analyze the role of paclitaxel on mortality, a deeper understanding of patient level data is required. Cook Medical is collaborating with medical societies, physicians, and industry partners to further review patient-level data and present the findings to FDA and at upcoming industry meetings.

If you have questions about our data or Zilver PTX, please contact us at zilverptx@cookmedical.com and a member of our team will respond
within 24 hours.

View Cook Medical letter to physicians on paclitaxel


RCT Data Disclosure

In the spirit of full transparency, which is a highly valued principle at Cook Medical, we are releasing de-identified patient-level data for our Zilver PTX Randomized Controlled Trial. The only modifications we’ve made to this data are designed to guarantee that patient privacy and confidentiality are always protected.



Request Complete Zilver PTX RCT Dataset

Terms and Conditions

The following Terms and Conditions apply for use of the Zilver PTX Randomized Controlled Trial dataset (the “Dataset”). Downloading the Dataset indicates your acceptance of the following Terms and Conditions so long as you retain any of the Dataset, regardless of format or storage method.

  • The Dataset is available for access by all parties at no charge.
  • No express or implied warranties are made with respect to the Dataset by any Cook Medical company, affiliate, or employee.
  • The Dataset will only be used for non-commercial research purposes and will not be used for any illegal purpose. No print out or electronic version of the Dataset or its contents may be used by you in any litigation or arbitration matter whatsoever under any circumstances.
  • The Dataset will not be processed in any way to attempt to identify clinical trial participants.
  • Cook Medical is not responsible for any data from the Dataset that has been modified, altered, or manipulated by any party.
  • Allowing public access to the Dataset does not confer any proprietary rights to the data contained therein to third parties.
  • You agree to allow Cook Medical to use your personal information to track users that request access to the Dataset.

Conference Presentations

Below we have collected recent presentations looking at the meta-analysis published in the Journal of the American Heart Association and reviewing our data on Zilver PTX.

LINC AP 2019

Presented by: Carlos Mena, MD  |  March 2019

The “intent-to-treat” analysis shows a 5-year all cause mortality rate of 22.1% for the Zilver PTX primary randomization arm and 15.3% for the PTA primary randomization arm (p-value = 0.04). However, this analysis does not recognize that 94 of the 237 patients (40%) in the primary PTA arm were actually treated with a Zilver PTX stent yet analyzed as PTA patients and not Zilver PTX patients in this intent-to-treat analysis.

View Presentation


CRT 2019

Presented by: Gary Ansel, MD  |  March 2019

The Zilver PTX RCT had a unique trial design. The RCT included a primary and secondary randomization, as well as an opportunity for patients in the PTA arm to cross over to treatment with Zilver PTX after experiencing a target lesion revascularization (TLR) in the first 12 months. As a result of this trial design, 40% of patients who were initially assigned to the PTA arm were subsequently treated with Zilver PTX. In total, 70% of the patients enrolled in this trial received a Zilver PTX stent.

View PresentationView Patient Flowchart


VLF 2019

Presented by: Michael Dake, MD  |  March 2019

The “as-treated” analysis shows a mortality rate of 18.7% for Zilver PTX patients and 17.6% for PTA/BMS patients (p-value = 0.53). This “as-treated” Zilver PTX group includes all patients who received a Zilver PTX stent.

View PresentationView 5-Year Kaplan-Meier Mortality


LINC 2019

Presented by: Michael Dake, MD  |  January 2019

Causes of death were examined between the “as-treated” Zilver PTX and PTA/BMS groups. There was no increased rate of cardiovascular, cancer, or other cause of death for Zilver PTX compared to PTA/BMS.

View PresentationView Causes of Death


VIVA 2018

Presented by: Michael Dake, MD  |  November 2018

Zilver PTX Global Data Analysis Highlights DES Benefits in Challenging Patient Populations.

View Presentation

Cook Medical Sponsored Webinar

Webinar

Is Paclitaxel safe in the periphery? The breakdown of the Zilver PTX data

In a Cath Lab Digest interview sponsored by Cook Medical, Drs. Michael Dake and Gary Ansel discuss 5-year Zilver PTX data that was recently published in Circulation.

View Webinar

Publications

Provided below are links to the selected original Zilver PTX data publications.

JACC Abstract

E-published ahead of Print: J Am Coll Cardiol  |  Secemsky et al.

“Drug-Eluting Stent Implantation and Long-term Survival following Peripheral Artery Revascularization”

View Abstract

5-year Publication

Published by: Circulation  |  Dake et al.

“Durable clinical effectiveness with paclitaxel-eluting stents in the femoropopliteal artery: 5-year results of the Zilver PTX randomized trial.”

View Publication

DCB/DES Animal Study

Published by: J Endovasc Ther.  |  Torii et al.

“Safety of Zilver PTX drug eluting stent implantation following drug coated balloon in healthy swine model.”

View Publication

12-month Publication

Published by: Circ Cardiovasc Interv  |  Dake et al.

“Paclitaxel-eluting stents show superiority to balloon angioplasty and bare metal stents in femoropopliteal disease: twelve-month Zilver PTX randomized study results.”

View Publication

Japan 2 Year Publication

Published by: Cardiovasc Intervent Radiol.  |  Kichikawa et al.

“Zilver PTX post-market surveillance study of paclitaxel-eluting stents for treating femoropopliteal artery disease in Japan: 2-year results.”

View Publication

Single-Arm Study

Published by: J Endovasc Ther  |  Dake et al.

“Nitinol stents with polymer-free paclitaxel coating for lesions in the superficial femoral and popliteal arteries above the knee: twelve-month safety and effectiveness results from the Zilver PTX single-arm clinical study.”

View Publication

Japan PMS Findings

Published by: J Vasc Interv Radiol.  |  Cipollari et al.

“Long-term effectiveness of the Zilver PTX drug-eluting stent for femoropopliteal peripheral arterial disease in patients with no tibial runoff vessels: Results from the Zilver PTX Japan post-market surveillance study.”

View Publication

Zilver PTX PK Data

Published by: J Vasc Interv Radiol  |  Dake et al.

“Polymer-free paclitaxel-coated Zilver PTX Stents–evaluation of pharmacokinetics and comparative safety in porcine arteries.”

View Publication

Zilver PTX EPI