At this year’s Vascular Interventional Advances (VIVA) conference (4–7 November, Las Vegas, USA), Michael D Dake presented data on Zilver PTX that supports the device’s benefits across different patient groups.
Dake presented the latest data regarding Zilver PTX, Cook Medical’s paclitaxel-coated stent that is used to treat peripheral arterial disease (PAD). His presentation focused on findings that Zilver PTX shows benefits for a variety of patients.
“Our ultimate goal is to help patients suffering from PAD. That is why these data are so important—behind each one of these data points is a real person. As we continue this discussion on paclitaxel-coated devices, we will keep providing as much information on Zilver PTX as we can so that patients and physicians can make the best decisions,” said Mark Breedlove, vice president of Cook Medical’s Vascular division.
In Cook Medical’s ongoing review of data relating to the Zilver PTX peripheral arterial stent, patient-level data for Zilver PTX were evaluated to determine if there was an increased mortality risk due to paclitaxel and the impact of risk factors on outcomes. Data presented at VIVA was collected from a five-year randomised controlled trial. In the trial, patients with PAD were initially randomised to be treated with either Zilver PTX or angioplasty. When the data were analysed, it was discovered that patients assigned to the Zilver PTX group had more risk factors than the control group, despite the trial’s randomisation of patient assignment.
The trial had a study design that allowed for patient crossover to treatment with Zilver PTX within the first year. Taking actual treatment into account, analyses of the complete 5-year data for Zilver PTX show no increase in long-term mortality for the paclitaxel-eluting stent. When evaluating potential risk factors for freedom from target lesion revascularisation (TLR), data continue to support the benefit of Zilver PTX across a variety of patient risk factor groups.
When considering treatment options for PAD, the FDA recommends that physicians discuss both risk and benefit possibilities with their patients.