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No Increased Mortality Seen With Paclitaxel Drug-Eluting Devices

THURSDAY, Oct. 9, 2019 -- Paclitaxel drug-eluting devices used for endovascular revascularization (EVR) of peripheral vessels do not appear to be associated with increased mortality over 11 years compared with uncoated devices, according to a study published online Oct. 9 in the European Heart Journal.

Eva Freisinger, M.D., from University Hospital Muenster in Germany, and colleagues retrieved data on the application of paclitaxel-based drug-eluting stents (DES) and drug-coated balloons (DCB) since their introduction in 2007. All patients who underwent first EVR of the iliac and lower limb arteries between 2007 and 2015 were identified, with follow-up through Dec. 31, 2017.

A total of 64,771 patients who underwent 107,112 EVR procedures using 23,127 drug-eluting devices were identified. For more than 11 years past application, paclitaxel-based DES was not associated with increased long-term mortality (all P > 0.057). For the first year past application, DCB was associated with reduced long-term mortality (hazard ratio, 0.92; P < 0.001); in the years thereafter, the difference was not statistically significant (all P > 0.202).

"Our findings show that paclitaxel-based devices are safe and are not associated with an increase of death. To our knowledge, this is the largest real-life group of patients that has been evaluated with long-term follow-up from the time that paclitaxel-coated devices were first introduced," Freisinger said in a statement. "Our work provides a solid base of evidence that will be difficult to rebut. We expect the FDA and other regulatory authorities will very likely amend their statements on safety concerns on paclitaxel-based devices."

Several authors disclosed financial ties to the pharmaceutical industry.

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Posted: October 2019

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