New talking points developed by a Multi-Specialty Paclitaxel Coalition, of which the ACC is a part, aim to help clinicians discuss peripheral artery disease (PAD) treatment options with patients.

The talking points, which were also reviewed by the Food and Drug Administration (FDA), are in response to a recent meta-analysis of randomized trials suggesting an increased mortality rate after two years in PAD patients treated with paclitaxel-coated balloons and paclitaxel-eluting stents for femoropopliteal disease compared with patients treated with uncoated balloons or bare metal stents.

Specifically, the talking points state:

• Some balloons and stents used to treat symptoms resulting from blocked blood vessels in leg(s) are coated with the drug paclitaxel.
• Research studies show that paclitaxel-coated balloons and stents improve the chance that the treated blood vessel in your leg will remain open after your treatment and lower the likelihood that you will need a repeat procedure to re-open the vessel.
• However, an analysis in 2019 that combined the results from multiple studies indicated that the use of paclitaxel-coated balloons and stents may increase your chance of dying starting about two years after treatment. Although this analysis has limitations and further research is still ongoing, the available information as of April 2020 suggests that paclitaxel-coated device use may increase your chance of dying over the next two to five years compared to treatment with uncoated balloons or bare metal stents.
• There may be other options for the treatment of your symptoms, including medications, exercise, balloons, stents or other devices that do not contain paclitaxel, and surgery. You and your doctor should discuss the possible risks and benefits of all treatments to identify those options that are best for you.

The coalition, which includes the ACC, American College of Radiology, American Heart Association, Society for Cardiovascular Angiography and Interventions, Society for Vascular Medicine, Society of Interventional Radiology, Society for Vascular Surgery and Vascular and Endovascular Surgery Society, is actively working with the FDA, medical device manufacturers, and clinical investigators to advance the understanding of the long-term safety and effectiveness of paclitaxel-coated devices.

Read the FDA's guidance to health care providers on PAD treatment here.

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

Keywords: ACC Publications, Cardiology Magazine, Peripheral Arterial Disease, Paclitaxel, United States Food and Drug Administration, Drug-Eluting Stents, Research Personnel, American Heart Association, Radiology, Interventional, Radiography, Femoral Artery, Stents, Societies, Medical, Angiography, Risk Assessment, ACC Advocacy

< Back to Listings