(HealthDay News) — For endovascular treatment of peripheral artery disease, paclitaxel-coated devices do not result in higher mortality than uncoated devices, according to a study published online in the New England Journal of Medicine.
Joakim Nordanstig, MD, PhD, from Gothenburg University in Sweden, and colleagues conducted an unplanned interim analysis of data from a randomized, open-label, registry-based clinical trial involving patients with symptomatic peripheral artery disease. A total of 2289 patients had been randomly assigned to treatment with drug-coated devices (1149 patients) or treatment with uncoated devices (1140 patients) at the time of analysis. For this interim analysis, the single end point was all-cause mortality.
For all drug-coated devices, paclitaxel was used as the coating agent. The researchers found that 574 patients died during a mean follow-up of 2.49 years, including 25.5 and 24.6% of patients in the drug-coated and uncoated device groups, respectively (hazard ratio, 1.06; 95% confidence interval, 0.92 to 1.22). All-cause mortality was 10.2 and 9.9% in the drug-coated and uncoated device groups, respectively, at one year. No significant difference was seen in the incidence of death between the treatment groups among patients with chronic limb-threatening ischemia (33.4% drug-coated and 33.1% uncoated) or among those with intermittent claudication (10.9 vs 9.4%) during the follow-up period.
“An unplanned interim analysis did not show a significantly higher all-cause mortality rate with paclitaxel-coated devices during 1 to 4 years of follow-up,” the authors write.
One author disclosed financial ties to a medical device company.