A new FDA letter confirms late mortality signal with paclitaxel eluting stents and paclitaxel coated balloons in peripheral territory. Even though this recently published letter confirms data, there are no new recommendations on the use of these devices.
After careful consideration of their own analyzis outcomes and a 2-day discussion of an advisory panel especially convened, the FDA explained that confirming results on the safety and efficacy of these devices requires clinical trials to continue.
These studies require appropriately informed consent and exhaustive safety monitoring to protect enrolled patients. Informed consent should further extend to all cases where paclitaxel eluting stents and coated balloons might be used.
Based on these conclusions and panel recommendations, the FDA is taking additional measures to confirm mortality increase that include working closely with companies and researchers to improve devices and clinical trials in the long term.
Increased mortality associated with paclitaxel devices called the endovascular community’s attention for the first time when Dr. Konstantinos Katsanos published his meta-analysis back in December 2018. This analysis was the first to show that the use paclitaxel devices in patients with femoropopliteal disease was associated with increased all-cause mortality risk at 2 and 5 years.
The FDA only flagged this risk in January and followed with the preliminary results of their own trials in March. The agency suggested the need to assemble a special panel to look further into these transcatheter devices, which happened in June.
Finally, in August 2019, the panel concluded long-term mortality is associated with the use of paclitaxel eluting stents and coated balloons in femoropopliteal territory. The FDA panel agreed there is a strong association but warned this should be interpreted with caution since there are multiple limitations to the available data. The studies are not large enough for us to reach definite conclusions and although these devices all release paclitaxel, we are looking at different doses released by quite different devices.
Finally, it was impossible to identify the physiopathological mechanism of these late deaths.
Original Title: treatment of peripheral arterial disease with paclitaxel-coated balloons and paclitaxel-eluting stents potentially associated with increased mortality.
Reference: US Food and Drug Administration. August 7, 2019 update.
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