FDA Perspective in NEJM highlights need for continued clinical studies on paclitaxel devices

Misti Malone presenting at VIVA 2019

Following the publication of the SWEDEPAD interim analysis, Andrew Farb, Misti Malone, and William H Maisel, representatives of the Center for Devices and Radiological Health, US Food and Drug Administration (FDA), have authored a perspective piece in the New England Journal of Medicine (NEJM), titled,Drug-coated devices for peripheral arterial disease [PAD]”.

“Percutaneous revascularisation procedures can improve claudication symptoms, and devices coated with antiproliferative drugs (drug-coated balloons and stents) reduce neointimal proliferation after revascularisation procedures. Pivotal randomised, controlled trials (RCTs) of paclitaxel-coated devices [PCDs] in patients with femoropopliteal PAD reveal significantly reduced repeat-revascularisation rates as compared with use of uncoated devices. Reasonable assurance of device safety and effectiveness at one year has led the FDA to approve six PCDs to date, and their use has become common in symptomatic patients,” they write in NEJM.

“The results of the SWEDEPAD interim analysis provide important and reassuring information on PCDs used to treat femoropopliteal disease,” say Farb et al. “Furthermore, recent analyses of additional data from nonrandomised studies have not identified an increased mortality risk associated with PCDs.”

However, they also add that these newer analyses, “though comforting, are limited by the duration of follow-up”.

“Because of the demonstrated short-term benefits of the devices and the limitations of the available data, the FDA believes that clinical studies of these devices should continue and should collect long-term mortality data. Similarly, the FDA now routinely reviews longer-term data for PCDs for which market authorisation is being sought when they are intended to treat patients with PAD, and the agency requests that trials capture information on adjunctive antithrombotic therapy and medications indicated for patients with atherosclerosis,” they conclude.


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