Early FDA Review Finds Increased Mortality for Some Treated With Paclitaxel-Coated Devices
The US Food and Drug Administration (FDA) said Friday that a preliminary review of long-term follow-up data has identified a “potentially concerning signal of increased long-term mortality” in study subjects treated for peripheral arterial disease with paclitaxel-coated balloons and paclitaxel-eluting stents when compared to patients treated with uncoated devices.“Of the three trials with 5-year follow-up data, each showed higher mortality in subjects treated with paclitaxel-coated products than subjects treated with uncoated devices. In total, among the 975 subjects in these 3 trials, there was an approximately 50% increased risk of mortality in subjects treated with paclitaxel-coated devices versus those treated with control devices (20.1% versus 13.4% crude risk of death at 5 years,” FDA said, following up on a January letter to health care providers on the same topic.
But the agency also said this data should be “interpreted with caution” because “the specific cause and mechanism of the increased mortality is unknown,” and because the studies were not designed to be pooled. In addition, FDA said there is “large variability in the risk estimate of mortality due to the limited amount of long-term data.”
Moving forward, FDA said alternative treatment options “should generally be used for most patients while we continue to further evaluate the increased long-term mortality signal and its impact on the overall benefit-risk profile of these devices.”
The agency is also planning to bring together an advisory committee meeting of the Circulatory System Devices Panel on the topic to, among other things, re-examine the benefit-risk profile of this group of devices and consider modifications to ongoing and future clinical trials evaluating devices containing paclitaxel.
UPDATE: Treatment of Peripheral Arterial Disease with Paclitaxel-Coated Balloons and Paclitaxel-Eluting Stents Potentially Associated with Increased Mortality - Letter to Health Care Providers