Study of 65K patients finds paclitaxel-coated devices safe
A study published just two months after the FDA issued a statement acknowledging a late mortality signal with paclitaxel-coated and -eluting stents and balloons suggests the devices are actually safe in patients with lower extremity artery disease (LEAD).
Paclitaxel, an agent that prevents cell proliferation, has long been used for coating stents and balloons because it limits the growth of scar tissue and minimizes any recurrence of restenosis, Eva Freisinger, a physician with the University Hospital Munster in Germany, and colleagues wrote in the European Heart Journal Oct. 9. In Germany alone, paclitaxel-coated devices typically account for 97% of balloons and drug-eluting stents implanted each year.
But that changed in late 2018, when a meta-analysis of patients being treated for femoropopliteal disease found that all-cause mortality at two and five years was higher among patients treated with paclitaxel balloons and stents. Just two months later, Circulation issued a correction revealing the results of the 2016 Zilver PTX trial—which studied the impact of paclitaxel-eluting stents and percutaneous transluminal angioplasty (PTA) on long-term outcomes in patients with peripheral artery disease (PAD)—had been “inadvertently reversed” to reflect a false long-term survival benefit with paxlitaxel devices.
The results of both studies pushed the FDA to launch its own investigation into paclitaxel devices, which wrapped this summer with a vague recommendation to continue sales of the devices so long as they’re used as indicated. But a letter issued Aug. 7 flipped the script by acknowledging a late mortality signal associated with the devices.
According to Freisinger et al., the 2018 meta-analysis and subsequent FDA warnings cut the use of paclitaxel devices by 50%.
Freisinger’s team undertook the largest, most long-term study to date of patients with LEAD and paclitaxel implants, following 64,771 real-world patients for more than 11 years. Participants underwent 107,112 procedures to unblock arteries between 2007—the year paclitaxel was first used to coat stents and balloons—and 2015, and they were followed until 2017.
No patients in the study had been treated previously with a paclitaxel device, but by 2017, a total of 23,137 drug-eluting devices had been implanted. And after more than a decade of follow-up, Freisinger and colleagues failed to find an increased risk of death from any cause associated with the use of paclitaxel devices. Paclitaxel-coated balloons were actually tied to a slightly decreased risk of death during the first year of implantation, but that benefit tapered off in subsequent years.
“Our findings show that paclitaxel-based devices are safe and are not associated with an increase of death,” 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.”
She said the study’s strength lies in the number of patients involved and the length of follow-up.
“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,” she said. “Our study illustrates the value of research using data from health services to rapidly assess safety concerns in real-life groups of patients.”
After graduating from Indiana University-Bloomington with a bachelor’s in journalism, Anicka joined TriMed’s Chicago team in 2017 covering cardiology. Close to her heart is long-form journalism, Pilot G-2 pens, dark chocolate and her dog Harper Lee.