Side Effects of Paclitaxel-Coated Balloon and Stents Linked To Increased Risk of Death, FDA Warns

Federal health officials warn patients receiving medical stents and balloons coated with paclitaxel could face an increased risk of death.

The FDA issued a Letter to Health Care Providers on March 15, warning that paclitaxel-coated balloons and paclitaxel-eluting stents used to treat peripheral arterial disease (PAD) may face a 50% increased risk of death when compared to treatment with uncoated devices.

The devices are meant to treat lesions in the femoropopliteal artery, opening up the obstructed vessel. When coated with paclitaxel, 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.

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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 study, 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.

FDA officials announced that while the analysis is still ongoing, the preliminary review of data over a five-year span indicates there may be something to be worried about. Of the 975 case studies reviewed, patients receiving coated products had approximately a 50% increased risk of mortality.

As a result of the findings, FDA officials are advising medical professionals to use alternative treatment options for most patients unless absolutely medically necessary. Officials will continue reviewing study data to determine whether the benefits of coated balloons and paclitaxel-eluting stents outweigh the risks.

The FDA’s Circulatory System Devices Panel Advisory Committee is currently organizing a meeting to further discuss the magnitude of long-term mortality risks associated with coated balloons and paclitaxel-eluting stents, and will begin conversations to discuss plausible reasons for this increased fatality rate.

The committee will also begin re-examining the benefit-risk profile of the coated devices and consider modifying ongoing and future U.S. clinical trials to better capture data that could indicate long-term mortality side effects.

The FDA is asking healthcare professionals to continue monitoring their patients who have been treated with paclitaxel-coated balloons and paclitaxel-eluting stents, and to discuss the risks and benefits of all available PAD treatment options with patients.

As the investigation continue, officials are urging healthcare providers to report any adverse events or suspected adverse health consequences related to the use of paclitaxel-coated balloons and paclitaxel-eluting stents to the FDA MedWatch Safety Information and Adverse Event Reporting program.


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