Contrary to a recent FDA advisory that acknowledged a late mortality signal with paclitaxel-coated and -eluting devices, a study published in the Journal of Endovascular Therapy found such stents safe in the long-term for treating femoropopliteal lesions in people with peripheral artery disease (PAD).
Paclitaxel devices for the treatment of PAD have been under the microscope for many months now, with an FDA-led investigation into the safety of paclitaxel-eluting stents and paclitaxel-coated devices culminating in an Aug. 7 announcement that confirmed a long-suspected late mortality signal with the equipment. Prior to the August advisory, the FDA had maintained that the benefits of paclitaxel devices outweighed their risks, and after a two-day debate in June, the agency issued a vague, nonbinding recommendation to continue the sales of such devices so long as they’re used as indicated.
For their work, Tomonori Katsuki, MD, and colleagues retrospectively analyzed paclitaxel-coated stent use in the femoropopliteal arteries of 1,535 symptomatic PAD patients treated between 2010 and 2016 at four hospitals in Japan. The researchers compared the risk of all-cause mortality in 285 patients treated with a paclitaxel-coated stent to the death risk in 1,250 patients treated with non-paclitaxel devices.
The team reported that three-year overall survival estimates were 86.4% in the paclitaxel-coated group and 87.7% in the paclitaxel-free group—a negligible difference. Five years into the study, survival estimates were 77.5% and 73.7%, respectively.
“There was no significant difference in all-cause mortality between the two groups,” Katsuki and co-authors wrote. “The cause of death also showed no remarkable difference between the groups.”
The authors said chronic renal failure and arterial calcification did demonstrate a significant interaction effect on the association of paclitaxel-coated stents with all-cause mortality, but no subgroups saw increased risks of all-cause death with the use of paclitaxel-coated stents. Mortality risk stayed steady irrespective of paclitaxel dose, as well, leading Katsuki et al. to deem treatment with paclitaxel-coated stents for femoropopliteal lesions a “safe option.”
The FDA is reportedly in the process of working with drug manufacturers to gather more clinical evidence on the long-term safety of paclitaxel-coated and -eluting devices. Until then, the agency recommends close monitoring of patients living with paclitaxel devices and recommends prioritizing shared decision-making for physicians and patients considering them as a treatment option.
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.