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# Researchers Find No Excess Deaths in Paclitaxel-Coated Devices
- URL: https://www.fdaweb.com/researchers-find-no-excess-deaths-in-paclitaxel-coated-devices/
- Published: 2020-12-10T12:00:00.000Z
- Updated: 2026-09-14T16:39:38.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5148280

Swedish researchers say that an interim analysis of data from a clinical trial in which patients with peripheral artery disease received treatment with either paclitaxel-coated or uncoated endovascular devices found no difference in all-cause mortality between the groups in the incidence of death during one to four years of follow-up. The researchers [reported](https://www.nejm.org/doi/full/10.1056/NEJMoa2005206?query=featured%5Fhome&ref=fdaweb.com) in the *New England Journal of Medicine* that they published their results before the trial’s end to reduce patients’ and physicians’ concerns about the safety of paclitaxel-coated devices and because they consider the data to be important to support completion of ongoing trials investigating the efficacy of such devices in peripheral artery disease.

In 8/2019, FDA [said](https://www.fdaweb.com/login.php?sa=v&aid=D5144709&searchWords=paclitaxel&cate=S&stid=%241%243v2.O.2.%247Ivxak.PtlpjiGdHdg9kW1) that because of ongoing concerns about a late mortality signal in patients treated for peripheral artery disease with paclitaxel-coated balloons and paclitaxel-eluding stents, it was working with manufacturers on updated device labeling and clinical trial informed consent documents. An 8/7/19 letter to doctors said the agency was also continuing to push for additional clinical evidence development for assessing the long-term safety of paclitaxel-coated devices.