An update was provided by the US Food and Drug Administration regarding the late mortality signal seen with paclitaxel-coated balloons and stents in patients with PAD, but it did not provide any major new recommendations regarding their use.
The agency reported that, “The FDA is taking additional steps to address this signal, including working with manufacturers on updates to device labelling and clinical trial informed
consent documents to incorporate information about the late mortality signal, based on the conclusions of our analysis and recommendations of the advisory panel.”It further adds, “For the assessment of the long-term safety of paclitaxelcoated devices, the FDA is continuing to actively work with the manufacturers and investigators on additional clinical evidence development.”
The FDA reported in its new update that,“It was concluded by the panel that a late mortality signal associated with the use of paclitaxel-coated devices to treat femoropopliteal PAD was present,” it further adds,“The panel and the FDA agreed that the magnitude of the signal should be interpreted with caution because of multiple limitations in the available data including wide confidence intervals due to a small sample size, pooling of studies of different paclitaxel-coated devices that were not intended to be combined, substantial amounts of missing study data, no clear evidence of a paclitaxel dose effect on mortality, and no identified pathophysiologic mechanism for the late deaths.”
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