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.
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.
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.
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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.
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.
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.
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.
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.
Zilver PTX Global Data Analysis Highlights DES Benefits in Challenging Patient Populations.
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.
Provided below are links to the selected original Zilver PTX data publications.
E-published ahead of Print: J Am Coll Cardiol | Secemsky et al.
Published by: Circulation | Dake et al.
Published by: J Endovasc Ther. | Torii et al.
Published by: Circ Cardiovasc Interv | Dake et al.
Published by: Cardiovasc Intervent Radiol. | Kichikawa et al.
Published by: J Endovasc Ther | Dake et al.
Published by: J Vasc Interv Radiol. | Cipollari et al.
Published by: J Vasc Interv Radiol | Dake et al.