Sean Lyden (Cleveland, USA) talks to VEITHtv at the VEITHsymposium 2019 (19–23 November, New York, USA) about the “tumultuous” year for the industry following the publication of the 2018 Katsanos meta-analysis which showed an increased mortality risk with the use of paclitaxel-coated balloons at five-years in intermittent claudication patients.
Despite FDA analysis which indicated that there “was something to this signal”, Lyden explains that that the Katsanos meta-analysis “did not have patient-level data” and says VIVA Physicians’ findings saw the FDA’s 58% mortality signal fall to 27% through five-years. Lyden goes on to discusses his views on the inconsistent data and how it might affect practitioners, outlining the need for “informed consent” from patients.
“We have seen a huge downturn in the use of paclitaxel” says Lyden, adding however that there is now “a light at the end of the tunnel” with the FDA, regulators, physicians and industry all partnering to decide on the next steps including looking at “improving trial design”.
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