FDA: No excess mortality risk with paclitaxel-coated devices for PAD
Key takeaways:
- New guidance from the FDA states there is no excess mortality risk with paclitaxel-coated devices used to treat peripheral artery disease.
- Longer-term follow-up in studies assessing the devices is ongoing.
Warnings about excess mortality risk with paclitaxel-coated devices to treat peripheral artery disease are “no longer supported,” based on a updated review of relevant trial data, according to an FDA announcement.
The announcement applies to all paclitaxel-coated devices, including all models, lots and unique device identifiers, according to the FDA.
In a letter to health care providers, the agency stated that a review of the totality of available data and analyses do not support an excess mortality risk for paclitaxel-coated devices used to treat PAD. The FDA first issued a communication about the devices in August 2019, stating there was a late mortality signal observed for patients treated for PAD in the femoropopliteal artery with paclitaxel-coated balloons and paclitaxel-eluting stents.
As Healio previously reported, the long-term mortality risk was first detected in a summary-level meta-analysis published in December 2018. It was later confirmed by an FDA analysis. However, individual randomized trials and retrospective cohort studies did not demonstrate mortality signals and investigators were unable to pinpoint a mechanistic explanation for the signal. The FDA allowed the devices to remain on the market, working with industry on amended labeling and more thorough trial follow-up. The agency previously advised clinicians to conduct a deep discussion of the risks and benefits of the devices with patients.
In the updated letter, FDA noted that device manufacturers collaborated in an updated meta-analysis that included additional studies, more complete vital status information and longer-term follow-up compared with prior studies. For these studies, patient follow-up ranged from 2 to 5 years, with data from most studies available out to 5 years.
“FDA clinicians and statisticians reviewed the data and concluded that the updated randomized controlled trial meta-analysis does not indicate that the use of paclitaxel-coated devices is associated with a late mortality risk,” the agency wrote.
The FDA also reviewed additional analyses of risk for late mortality, including the SWEDEPAD trial interim analysis, VOYAGER PAD, the German BARMER Health Insurance study, the U.S. Veterans Health Administration study and the Medicare SAFE-PAD study.
“None of these studies, with mean or median follow-up ranging from 1.7 to 3.5 years, found a risk for late mortality associated with paclitaxel-coated devices,” FDA wrote.
The agency said longer-term follow-up for some of these studies is ongoing.