FDA Issues Letter on Potential Increased Mortality With Paclitaxel-Coated Devices in SFA

January 17, 2019—On its website, the FDA posted an advisory to peripheral interventionalists and vascular medicine physicians to inform them that the agency is evaluating recent information regarding the potential for increased long-term mortality after use of paclitaxel-coated balloons and paclitaxel-eluting stents to treat peripheral artery disease (PAD) in the femoropopliteal artery. There are a number of these devices approved or under study for peripheral vascular use in the United States.

As noted by the FDA, a recent meta-analysis of randomized trials suggests a possible increased mortality rate after 2 years in PAD patients treated with paclitaxel-coated balloons and paclitaxel-eluting stents compared with patients treated with control devices (noncoated balloons or bare-metal stents). The specific cause for this observation is yet to be determined. The study was published by Konstantinos Katsanos, MD, et al online in Journal of the American Heart Association (JAHA).

The agency concluded that it believes that 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 recommends that health care providers:

• Continue surveillance of patients who have been treated with paclitaxel-coated balloons and paclitaxel-eluting stents per the current standard of care
• In clinical decision-making, discuss the risks and benefits of all available treatment options for PAD with your patients
• Report any adverse events or suspected adverse events experienced with the use of paclitaxel-coated balloons and paclitaxel-eluting stents

Voluntary reports can be submitted through MedWatch. Device manufacturers and user facilities must comply with the applicable Medical Device Reporting (MDR) regulations.

Health care personnel employed by facilities that are subject to FDA's user facility reporting requirements should follow the reporting procedures established by their facilities.

Prompt reporting of adverse events can help the FDA identify and better understand the risks associated with medical devices, noted the advisory.

The FDA is currently evaluating available long-term follow-up data to determine if there are any long-term risks associated with paclitaxel-coated products. This will include an evaluation of long-term follow-up data from studies that supported approval of paclitaxel-coated balloons or paclitaxel-eluting stents in the United States and other available data sets.

This review will focus on the causes of death, the paclitaxel dose delivered, and patient characteristics that may impact clinical outcomes. Additional statistical analyses will be performed to clarify the presence and magnitude of any long-term risks. Additionally, FDA is working with manufacturers of paclitaxel-coated balloons and paclitaxel-eluting stents to better understand this issue.

The FDA will communicate with the public as new information becomes available.