FDA to evaluate potential risks of paclitaxel-coated devices for PAD

The FDA is looking into the signal of increased late mortality associated with paclitaxel-coated balloons and stents that was observed in a recent meta-analysis of patients treated for femoropopliteal artery disease.

That meta-analysis found all-cause death was increased by 68 percent at two years and 93 percent at five years for patients treated with the paclitaxel-covered devices compared to a control group which received uncoated balloons or bare-metal stents. Following the study’s publication in December, two trials designed to evaluate drug-coated devices in patients with peripheral artery disease (PAD) were halted.

In a letter to physicians, the FDA said it was evaluating this information and pointed out the cause of the higher mortality rates “is yet to be determined.” The agency recommended clinicians discuss the risks and benefits of all available treatment options for PAD with their patients; continue to monitor patients who have been treated with paclitaxel-coated devices; and report any adverse events or suspected adverse events with those devices through the MedWatch program.  

The agency plans to assess the available long-term follow-up data for paclitaxel-coated products, several of which have already been approved for commercial use. The review will also focus on causes of death, the doses delivered and patient characteristics that may affect clinical outcomes, according to the FDA.

Device manufacturers—who recently backed their products in the wake of the study—will work with the FDA during the review process.

“Currently, the FDA 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 letter said. “The FDA will communicate with the public as new information becomes available.”

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