• FDA: Paclitaxel Device Studies May Continue; Patients Should Be Informed of Late Mortality Signal; Will Work with Manufacturers to Change Labeling

    Clinical studies of paclitaxel-coated devices for use in the peripheral arteries may continue and should collect long-term safety – including mortality – and effectiveness data, the U.S. Food and Drug Administration said Wednesday.

    The FDA said this in an updated letter to health-care providers, which also included several recommendations for providers, and a summary of the two-day meeting of the Circulatory System Devices Panel of the Medical Devices Advisory Committee held in June. The FDA had previously issued letters to providers in January and March.

    “Because of the demonstrated short-term benefits of the devices, the limitations of the available data, and uncertainty regarding the long-term benefit-risk profile of paclitaxel-coated devices, the FDA believes clinical studies of these devices may continue and should collect long-term safety (including mortality) and effectiveness data,” the agency’s letter says. “These studies require appropriate informed consent and close safety monitoring to protect enrolled patients.”

    The FDA’s summary of the advisory panel meeting noted that both the panel and FDA agreed that while there is a late mortality signal associated with the use of paclitaxel-coated devices to treat femoropopliteal peripheral artery disease (PAD), “the magnitude of the signal should be interpreted with caution because of multiple limitations in the available data.”

    Those limitations include wide confidence intervals because of a small sample size, pooling of studies with different paclitaxel-coated devices (i.e., drug-coated balloons and drug-eluting stents) 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 late deaths.

    “The Panel determined, and the FDA concurs, that additional clinical study data are needed to fully evaluate the late mortality signal,” the letter says.

    The late mortality signal was first reported in a meta-analysis by Katsanos and colleagues published in December in the Journal of the American Heart Association.

    The FDA’s recommendations for providers include the following:

    • Continue diligent monitoring of patients who have been treated with paclitaxel-coated balloons and paclitaxel-eluting stents.
    • When making treatment recommendations, and as part of the informed consent process, consider that there may be an increased rate of long-term mortality in patients treated with paclitaxel-coated balloons and paclitaxel-eluting stents.
    • Discuss the risks and benefits of all available PAD treatment options with your patients. For many patients, alternative treatment options to paclitaxel-coated balloons and paclitaxel-eluting stents provide a more favorable benefit-risk profile based on currently available information.

    Providers are also encouraged to report adverse events or suspected adverse events experienced with use of these devices to the FDA’s MedWatch reporting program.

    The agency added that it continues to work with manufacturers and investigators on developing additional clinical evidence to assess the long-term safety of paclitaxel-coated devices. The FDA also said it is working with manufacturers on labeling updates to include information about the late mortality signal and with investigators in ongoing paclitaxel-coated device trials to modify informed consent documents to include information about the late mortality signal.

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