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The United States Food and Drug Administration (FDA) warns physicians about a "signal of potential concern" of increased long-term mortality in paclitaxel-coated balloon stent-treated patients or paclitaxel-eluting stents. to treat a peripheral arterial disease (PAD) femoro-popliteal artery, announced the agency on March 15 in an updated letter to health care providers.
While the badyzes are ongoing, "because of this safety signal, we believe that alternative treatment options should generally be used for most patients while continuing to further evaluate the long-term mortality signal. its impact on the overall risk-benefit profile of these devices, "advised the FDA.
The warning letter follows a vascular leaders forum convened earlier this month to address the issue, in which FDA officials acknowledged that the safety signal was lingering in their initial investigation of the devices.
January 17, as reported by Medscape Medical News, the FDA informed health care providers of the potential for increased long-term mortality with paclitaxel-coated balloons and stents used to treat identified PADs in a meta-badysis of trials randomized.
This badysis, published in the Journal of the American Heart Association , reported an increased relative risk of 68% all-cause death with paclitaxel-coated balloons and stents starting at age 2 and increasing to 93% at 5 years.
The FDA conducted a preliminary badysis of the long-term follow-up data from the pre-market randomized trials of paclitaxel-coated products identified for the PAD.
Each of the three trials with 5-year follow-up data showed higher mortality in patients treated with paclitaxel-coated products than in their peers treated with uncoated devices. In total, among the 975 patients participating in these three trials, the risk of death increased by approximately 50% in patients treated with paclitaxel-coated devices compared to those treated with control devices (20.1). % versus 13.4% of the gross risk of death at age 5). years), said the FDA.
The data must be interpreted with caution for several reasons, the FDA said. "First, there is great variability in the estimation of mortality risk due to the limited amount of long-term data." Second, these studies were not originally designed to be As a result, the specific cause and mechanism of increased mortality is unknown, "the FDA said.
The FDA intends to conduct further badyzes to determine whether the benefits continue to outweigh the risks badociated with paclitaxel-coated paclitaxel-approved balloons and paclitaxel-eluting stents, when they are used as indicated currently.
In addition, they will convene a meeting of the Advisory Committee of the Circulatory System Devices Expert Group to review the benefit-risk profile of this device group and consider modifications to current and future clinical trials. in the United States evaluating devices containing paclitaxel, among other topics.
For now, the FDA recommends that health care providers consider the following:
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Discuss the risks and benefits of all the treatment options available for PAD with patients. "For most patients, alternative treatment options to paclitaxel-coated balloons and paclitaxel-eluting stents should generally be used until further badysis of the safety signal has been made", said the FDA.
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Ensure that patients receive optimal medical treatment for MAP and other cardiovascular risk factors, as well as advice on healthy lifestyles including weight control, discontinuation of tobacco and exercise
Providers are requested to report any adverse events or suspected adverse reactions experienced with these devices through MedWatch, FDA's safety information program, and reporting of adverse events.
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