There is no evidence of increased mortality risk from the use of paclitaxel coated devices, according to an analysis published today.
Following a safety alert earlier this year, German researchers set out to study mortality risk among patients using devices coated with a drug called paclitaxel.
These devices include stents and balloons used for arterial revascularisation in the lower limbs. Paclitaxel is added in order to limit the growth of scar tissue and reduce further blockages in the arteries.
The safety warning was released in January by the US Food and Drug Administration and was based on a meta-analysis of 28 trials involving 4,663 patients, indicating a doubling in mortality rate for people fitted with these devices.
Now, Dr Eva Freisinger, of the University Hospital Munster, Germany, and colleagues are publishing their study of 64,771 people which found no increase in deaths compared with patients using bare-metal stents or balloons not coated with paclitaxel.
Patients in the study underwent 107,112 procedures to unblock arteries with paclitaxel-coated devices, between 2007 and 2015. Details appear in the European Heart Journal today (9 October).
“Our findings show that paclitaxel-based devices are safe and are not associated with an increase of death,” said Dr Freisinger. “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.
“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.”
She added: “Our study illustrates the value of research using data from health services to rapidly assess safety concerns in real-life groups of patients.”
Freisinger, E. et al. Mortality of paclitaxel-based devices: a real-world safety analysis. European Heart Journal 9 October 2019 doi: 10.1093/eurheartj/ehz698
https://academic.oup.com/eurheartj/article-lookup/doi/10.1093/eurheartj/ehz698
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