Earlier this year, the U.S. Food and Drug Administration (FDA) notified health care providers about a potential late mortality signal in patients treated for peripheral artery disease (PAD) in the femoropopliteal artery with paclitaxel-coated balloons and paclitaxel-eluting stents. Following these notifications, the FDA Circulatory System Devices Panel of the Medical Devices Advisory Committee met in June to discuss and make recommendations on this potential late mortality signal. Sahil A. Parikh, MD, FACC, presented on behalf of the ACC as a member of a multi-specialty coalition, and W. Schuyler Jones, MD, FACC, presented on behalf of the NCDR and ACC's PVI Registry.

The panel concluded that a late mortality signal associated with the use of paclitaxel-coated devices to treat femoropopliteal PAD was present, and that additional clinical study data are needed to fully evaluate the late mortality signal.

In the meantime, the FDA has issued additional recommendations for health care providers and patients considering using paclitaxel-coated balloons and paclitaxel-eluting stents. Recommendations include:

• 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 patients.
• 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.
• Report any adverse events or suspected adverse events experienced with the use of paclitaxel-coated balloons and paclitaxel-eluting stents. 

Read the FDA announcement.

Keywords: ACC Advocacy, Peripheral Arterial Disease, Paclitaxel, Advisory Committees, Smoking Cessation, Cardiovascular Diseases, Femoral Artery, Stents, Physicians, Constriction, Pathologic

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