Five-Year Data Analysis Shows Benefit, No Increased Mortality With Cook Medical’s Zilver PTX Across Different Patient Groups

 

November 5, 2019—Cook Medical announced that data supporting the benefits of the company’s Zilver PTX paclitaxel-coated stent to treat peripheral artery disease (PAD) across different patient groups were presented by Michael D. Dake, MD, at VIVA 2019, the Vascular InterVentional Advances meeting held November 4–7 in Las Vegas, Nevada.

In Cook Medical’s ongoing review of data relating to the Zilver PTX device, patient-level data were evaluated to determine if there was an increased mortality risk caused by paclitaxel and the impact of risk factors on outcomes.

The data presented at VIVA were collected from a 5-year randomized controlled trial composed of patients with PAD who were initially randomized to be treated with either Zilver PTX or angioplasty.

An analysis of the data showed that patients assigned to the Zilver PTX group had more risk factors than the control group, despite the trial’s randomization of patient assignment.

According to the company, 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 revascularization, 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, noted Cook Medical.

 

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