FDA schedules June meeting to discuss safety of paclitaxel devices

The FDA’s Circulatory System Devices Panel of the Medical Devices Advisory Committee will meet in mid-June to discuss recent controversies and safety practices surrounding paclitaxel-coated and -eluting medical devices, according to a notice posted April 22.

The agency’s announcement comes two months after a Feb. 19 correction in Circulation inverted the results of the 2016 Zilver PTX trial, finding the study’s five-year mortality results were “inadvertently reversed” to reflect a long-term survival benefit with paclitaxel-eluting stents compared to percutaneous transluminal angioplasty (PTA) for peripheral artery disease (PAD).

The corrected study, which had been cited over the years as evidence of the long-term safety of paclitaxel devices, clarified that all-cause mortality rates were 16.9% in the drug-eluting stent group and 10.2% in the PTA group. The safety of such paclitaxel stents had already been thrown into question at the time Circulation issued the correction, having come under fire months earlier in a Journal of the American Heart Association meta-analysis.

The meta-analysis pooled results from 28 randomized controlled trials and concluded all-cause mortality rates at two and five years were higher in patients treated for femoropopliteal disease with paclitaxel balloons and stents than in those treated with uncoated devices. Relative increases in mortality in the paclitaxel group reached 68% at two years and 93% at five years—disconcerting stats that triggered the halt of two clinical trials.

In a letter addressed to peripheral interventionalists and vascular medicine physicians Jan. 17, the FDA assured health professionals the agency would be looking into the safety of paclitaxel devices but maintained they believed “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 agency’s summer meeting is slated for June 19 and 20 and will take place at the Gaithersburg Holiday Inn in Gaithersburg, Md. According to the notice, the meeting will be open to the public, and anyone interested can present data, information or their views before the advisory committee.

“The committee will discuss and make recommendations on information related to recent observations of increased long-term mortality in PAD patients treated with paclitaxel-coated balloons and paclitaxel-eluting stents compared to patients treated with uncoated comparator devices,” the notice read. “FDA requests panel input regarding the presence and magnitude of the signal and potential causes.”

The agency also said it’s looking for input on appropriate regulatory actions associated with the findings of the JAHA and Circulation studies. Any reps from the industry, professional organizations or societies who are interested in making formal presentations need to notify the FDA by May 22.