US FDA evaluating paclitaxel data, recommend patient surveillance


The impact of the 2018 meta-analysis of randomised paclitaxel-device trials, published in the Journal of the American Heart Association by Konstantinos Katsanos et al, continues to travel through the vascular world. As industry starts to respond to the conclusions made by Katsanos and colleagues, which highlighted an association between higher mortality rates in the long-term and use of paclitaxel-coated devices in the legs, the US Food and Drug Administration (FDA) has begun to evaluate its recommendations for the treatment. While the review of data is ongoing, “continued surveillance” is recommended for patients treated with paclitaxel, and the agency believes the “benefits continue to outweigh the risks” for approved devices used within their indications.

In a letter to healthcare providers, the FDA states that it is evaluating the “recent information regarding the potential for increased long-term mortality” following paclitaxel-coated balloon or paclitaxel-eluting stent treatments in the femoropopliteal artery for patients with peripheral arterial disease (PAD).

“The [meta-analysis] suggests a possible increased mortality rate after two years in PAD patients treated with paclitaxel-coated balloons and paclitaxel-eluting stents compared to patients treated with control devices (non-coated balloons or bare metal stents)”, the FDA states, adding “the specific cause for this observation is yet to be determined.”

While the FDA evaluate the data, in a review that it says “will focus on causes of death, the paclitaxel dose delivered, and patient characteristics that may impact clinical outcomes”, it recommends only that healthcare professionals continue to monitor patients who have received treatment with paclitaxel, to report any adverse events through the MedWatch reporting systems, and to discuss potential risks and benefits with patients during clinical decision-making for PAD. In fact, for currently approved paclitaxel devices, the FDA states that it believes “the benefits continue to outweigh the risks” when drug-eluting technology is used in accordance with the indications for use.

Impact on industry

An equity research report published by investment banking company Goldman Sachs predicts only limited risks for Philips, BD and Medtronic, as a result of the meta-analysis as drug-coated balloons (DCBs) and drug-eluting stents (DESs) represent only a small fraction of these companies’ total revenue.

However, they do state that Stellarex was one of the key reasons for Philips’ acquisition of Spectranetics in 2017, and as such, today’s news may be seen as “a minor headline negative”.


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