In a retrospective analysis of Japanese patients with peripheral artery disease treated with paclitaxel-coated devices or other devices, paclitaxel-coated devices were not associated with elevated mortality risk at 5 years.
The potential long-term mortality risk of paclitaxel-coated devices has been a hot topic since a signal was detected in a summary-level meta-analysis and confirmed in an FDA analysis. However, no cause for the signal has been found, and the FDA accepted the advice of its Circulatory System Devices Panel to allow the devices to remain on the market.
For the retrospective analysis, Tomonori Katsuki, MD, cardiologist at Kokura Memorial Hospital in Kitakyushu, Japan, and colleagues analyzed 1,535 patients with symptomatic PAD treated between 2010 and 2016 at four Japanese centers. Among the cohort, 285 patients were treated with paclitaxel-coated devices (mean age, 73 years; 213 men) and 1,250 patients (mean age, 73 years; 872 men) were not exposed to paclitaxel.
Survival estimates were 86.4% in the paclitaxel group and 87.7% in the paclitaxel-free group at 3 years and 77.5% in the paclitaxel group and 73.7% in the paclitaxel-free group at 5 years, according to the researchers.
There were no differences between the groups in all-cause mortality (HR = 0.89; 95% CI, 0.66-1.19) nor in causes of death, Katsuki and colleagues wrote.
There was no dose-response relationship nor any subgroup that showed elevated mortality from treatment with a paclitaxel-coated device, the researchers wrote, noting that chronic renal failure (P for interaction = .044) and arterial calcification (P for interaction = .022) had an interaction effect on the association between paclitaxel use and mortality.
“Mortality risk following application of a paclitaxel-coated stent did not increase over 5 years, irrespective of the dose,” Katsuki and colleagues wrote. “A paclitaxel-coated stent for femoropopliteal lesions in Rutherford category 2 to 4 patients is a safe treatment. Prospective and real-world studies are needed to clarify the mortality risk following application of paclitaxel.” – by Erik Swain
Disclosures: The authors report no relevant financial disclosures.