FDA Update - Treatment of Peripheral Arterial Disease with Paclitaxel-Coated Balloons and Paclitaxel-Eluting Stents Potentially Associated with Increased Mortality

PUBLISHED: Aug 7, 2019
Relevant to: All Healthcare Organizations

Earlier this year, the U.S. Food and Drug Administration (FDA) notified health care providers about a late mortality signal in patients treated for peripheral artery disease (PAD) in the femoropopliteal artery with paclitaxel-coated balloons and paclitaxel-eluting stents. The FDA is now issued an update to provide the latest information on thier analysis of long-term follow-up data from premarket trials and to provide summary information from our June 2019 advisory panel meeting. In addition, FDA is including recommendations to health care providers for assessing and treating patients with PAD using paclitaxel-coated devices.

This communication updates the January 17 and March 15, 2019, notifications to health care providers.

Based on the conclusions of the FDA’s analysis and recommendations of the advisory panel, the FDA is taking additional steps to address this signal, including working with manufacturers on updates to device labeling and clinical trial informed consent documents to incorporate information about the late mortality signal. The FDA is also continuing to actively work with the manufacturers and investigators on additional clinical evidence development for assessment of the long-term safety of paclitaxel-coated devices.


  • Continue diligent monitoring of patients who have been treated with paclitaxel-coated balloons and paclitaxel-eluting stents.
  • When making treatment recommendations, and as part of the informed consent process, consider that there may be an increased rate of long-term mortality in patients treated with paclitaxel-coated balloons and paclitaxel-eluting stents.
  • Discuss the risks and benefits of all available PAD treatment options with your patients. For many patients, alternative treatment options to paclitaxel-coated balloons and paclitaxel-eluting stents provide a more favorable benefit-risk profile based on currently available information.
  • For individual patients judged to be at particularly high risk for restenosis and repeat femoropopliteal interventions, clinicians may determine that the benefits of using a paclitaxel-coated device outweigh the risk of late mortality.
  • In discussing treatment options, physicians should explore their patients' expectations, concerns and treatment preferences.
  • Ensure patients receive optimal medical therapy for PAD and other cardiovascular risk factors as well as guidance on healthy lifestyles including weight control, smoking cessation, and exercise.

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