FDA: No Excess Mortality Risk From Paclitaxel Stents, Balloons for Peripheral Intervention

July 11, 2023

The US Food and Drug Administration (FDA) has determined that paclitaxel-delivering stents and balloons for peripheral-artery interventions do not pose an excess mortality risk, the agency said today in a statement to healthcare providers.

The FDA announcement comes about 4 years after it warned physicians of a "potentially concerning" signal of excess mortality linked to paclitaxel-coated balloons and paclitaxel-eluting stents in published analysis, as previously reported.

The agency's concerns had been based on a December 2018 meta-analysis in the Journal of the American Heart Association that saw a 68% jump in mortality risk at 2 years and a 93% excess risk at 5 years associated with the paclitaxel devices in the periphery.

The findings, which led an FDA advisory committee to recommend device labeling changes and otherwise upended the practice of peripheral interventions, were followed by an FDA recommendation to limit the use of paclitaxel devices in the periphery to higher-risk cases.

In its July 11 update to providers, the FDA said it was satisfied the devices do not pose an excess mortality risk. It based its conclusion on extensive further evidence review and recently available "additional data" from the randomized controlled trials (RCTs) contributing to the meta-analysis that had ignited the controversy.

"FDA clinicians and statisticians reviewed the study data," the agency said, "and concluded that the updated RCT meta-analysis does not indicate that the use of paclitaxel-coated devices is associated with a late mortality risk."

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