The FDA said last week that its preliminary review of long-term follow-up data found a “potentially concerning signal” of increased long-term mortality in people with peripheral artery disease who were treated with paclitaxel-coated devices compared to those treated with bare devices.
In a letter to healthcare providers, the U.S. regulatory agency reported that there was a 50% increased risk of mortality in people treated with paclitaxel-coated devices versus those treated with control devices in the three trials with five-year follow-up data.
Importantly, the FDA urged doctors to interpret these data with caution.
“First, there is large variability in the risk estimate of mortality due to the limited amount of long-term data. Second, these studies were not originally designed to be pooled, introducing greater uncertainty in the results. Third, the specific cause and mechanism of the increased mortality is unknown,” the agency wrote.
The FDA said that doctors should seek alternative treatment options for patients while the agency assesses the long-term mortality signal linked to paclitaxel devices.
“The FDA intends to conduct additional analyses to determine whether the benefits continue to outweigh the risks for approved paclitaxel-coated balloons and paclitaxel-eluting stents when used in accordance with their indications for use,” the FDA wrote. “The FDA will also evaluate whether these analyses impact the safety of patients treated with these devices for other indications, such as treatment of arteriovenous access stenosis or critical limb ischemia.”
The FDA plans to convene an advisory committee meeting of the Circulatory System Devices Panel to hold a discussion on the long-term mortality signal. The timing of the adcomm meeting has not yet been announced.
The FDA’s latest moves come in response to a meta-analysis that was published last year in the Journal of the American Heart Association. The study suggested that paclitaxel devices were linked to a heightened mortality rate in people with PAD who were treated with paclitaxel-coated and paclitaxel-eluting devices compared to bare devices.