The U.S. Food and Drug Administration (FDA) published a letter on July 11 informing health care providers that excess mortality risk associated with paclitaxel-coated devices used for peripheral arterial disease (PAD) treatment is no longer supported based on a review of available data and analyses.

Since the FDA’s previous communication on this topic in 2019, new data from pivotal randomized controlled trials has become available, along with an updated meta-analysis by device manufacturers that featured “additional studies, more complete vital status information and longer-term follow-up compared to prior studies.” The agency also factored in analyses concerning risk for late mortality, including the SWEDEPAD trial interim analysis, the VOYAGER PAD study, the German BARMER Health Insurance study, the U.S. Veterans Health Administration study and the Medicare SAFE-PAD study.

The FDA recommends health care providers discuss risks and benefits of all available PAD treatment options with their patients, continue routine monitoring of patients treated with paclitaxel-coated balloons and paclitaxel-eluting stents, and report any adverse events to the agency. For more information and additional recommendations, access the FDA website. Access CardioSmart tools to discuss PAD with patients, including a new “What is PAD?” handout, here.

Clinical Topics: Invasive Cardiovascular Angiography and Intervention, Vascular Medicine, Atherosclerotic Disease (CAD/PAD), Interventions and Vascular Medicine

Keywords: Randomized Controlled Trials as Topic, Risk Assessment, Stents, Peripheral Arterial Disease, Medicare, Veterans, Follow-Up Studies, Drug-Eluting Stents, United States Food and Drug Administration, Paclitaxel, United States

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