Paclitaxel-Coated Balloons And Stents May Increase Risk Of Death, But Clinical Trials Can Continue: FDA

Federal regulators indicate that clinical trials involving stents and balloons coated with paclitaxel can continue, despite growing evidence they may increase the risk of death.

On August 7, the FDA issued a letter to healthcare providers, providing updated information about an ongoing investigation into the potential increased risk of problems linked to heart balloons and stents coated with paclitaxel.

The agency called for updating device labeling and ensuring those involved in clinical trials have provided informed consent about the potential risks. However, the FDA determined the clinical trials do not need to be halted.

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The devices are meant to treat lesions in the femoropopliteal artery, opening up the obstructed vessel. When coated with paclitaxel, sold under the brand names Abraxane and Taxol, the drug prevents scar tissue formation and has been found to help improve blood flow to the legs and decrease the likelihood of repeat procedures to reopen blocked blood vessels.

Late last year, a study was published by the Journal of the American Heart Association, finding patients implanted with the devices had higher complication and mortality rates.

As a result of the findings, FDA officials released an update in January 2019, announcing an in-depth, long-term follow-up analysis of the study. The review focused on causes of death, the paclitaxel dose delivered, and patient characteristics that may impact clinical outcomes.

The information in this latest update comes primarily in the wake of an advisory committee meeting held in June. The update outlines additional steps healthcare providers should take, including providing informed consent to patients and close safety monitoring of enrolled patients. The steps are focused on providing a safe trial environment while gathering necessary data to determine if there is a late mortality risk for paclitaxel-coated devices for patients with peripheral artery disease (PAD).

Clinical studies of the devices were brought to a halt after the June meeting due to the concerns that participants may face a higher than acceptable risk of death. Now, however, the FDA is allowing clinical studies to continue, and is working with manufacturers and investigators on those trials.

The agency hopes that by continuing the clinical trials, it can better assess the long-term safety of paclitaxel-coated devices.

“The Panel concluded that a late mortality signal associated with the use of paclitaxel-coated devices to treat femoropopliteal PAD was present,” the FDA’s letter states. “The Panel determined, and the FDA concurs, that additional clinical study data are needed to fully evaluate the late mortality signal.”

The FDA added a number of recommendations for health care providers, including:

  • Continued monitoring of patients treated with paclitaxel-coated balloons and paclitaxel-eluding stents.
  • Consider the potential increased long-term mortality rate when making treatment recommendations involving these balloons and stents.
  • Discuss the risks and benefits of all available treatment options with patients.
  • Discuss patients’ concerns, expectations and treatment preferences.

The FDA also calls for doctors and patients to report any adverse events or health complications involving these devices to the MedWatch adverse event reporting system.


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