October 6, 2020

Multispecialty Coalition Develops Talking Points on Patient Safety for Treatment With Paclitaxel Device

October 6, 2020—The Multi-Specialty and Multi-Society Coalition for Patient Safety with Paclitaxel Technologies has developed a set of talking points for informing patients about the risks and benefits of paclitaxel-coated endovascular devices in the treatment of peripheral artery disease (PAD). The FDA tasked the coalition to develop these talking points, which are the result of discussions across specialties.

The Society for Cardiovascular Angiography and Intervention (SCAI), represented by Mehdi Shishehbor, DO, in these discussions, recently posted the coalition statement, which reviews the background of the paclitaxel controversy and outlines the talking points on the SCAI website.

In addition to SCAI, the coalition is composed of the following societies representing the majority of specialists who evaluate and treat patients with PAD: American College of Cardiology, American College of Radiology, American Heart Association, Society for Vascular Medicine, Society of Interventional Radiology, Society for Vascular Surgery, Vascular and Endovascular Surgery Society, and Society for Clinical Vascular Surgery.

According to the statement, the coalition bullet points (which have been reviewed by the FDA) reflect the current evidence surrounding this complex topic and are designed to help institutions and members when discussing potential concerns of increased rates of long-term mortality in patients treated with paclitaxel-coated balloons and paclitaxel-eluting stents.

In the document posted by Dr. Shishehbor and SCAI, the coalition advised, “The statements are intended to summarize the current state of the evidence and to serve as starting points for discussion. We recognize this is a complex issue, and the talking points are not intended to take the place of thoughtful, individualized discussions with patients. The ability to effectively communicate risks and benefits of revascularization is a key part of patient management. Please consider the following statement as helpful guidance in your discussions and informed consent process.”

The talking points that physicians/providers may consider when discussing PAD treatment options with their patients are:

  • 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 reopen the vessel.
  • However, an analysis in 2018 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 2 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 2-5 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 is actively working with FDA, medical device manufacturers, and clinical investigators to advance the understanding of the long-term safety and effectiveness of paclitaxel-coated devices, concluded the statement.

The coalition’s statement refers to the meta-analysis of randomized trials by Konstantinos Katsanos, MD, et al published in December 2018 in Journal of the American Heart Association that suggests an increased mortality rate after 2 years in patients with PAD treated with paclitaxel-coated balloons and paclitaxel-eluting stents for femoropopliteal disease, compared with patients treated with uncoated balloons or bare-metal stents. Subsequently, in August 2019, the FDA issued an update on the use of paclitaxel devices to treat PAD that recommended that physicians discuss the risks and benefits of all available treatment options with their patients.

Endovascular Today’s Continuing Coverage: Paclitaxel in PAD provides a comprehensive collection of primary source documents, articles, and news coverage.


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