Interim analysis shows no increased rate of all-cause mortality with paclitaxel-coated versus uncoated devices
THURSDAY, Dec. 17, 2020 (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 Dec. 9 in the New England Journal of Medicine.
Joakim Nordanstig, M.D., Ph.D., 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 2,289 patients had been randomly assigned to treatment with drug-coated devices (1,149 patients) or treatment with uncoated devices (1,140 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 percent of patients in the drug-coated and uncoated device groups, respectively (hazard ratio, 1.06; 95 percent confidence interval, 0.92 to 1.22). All-cause mortality was 10.2 and 9.9 percent 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 percent drug-coated and 33.1 percent uncoated) or among those with intermittent claudication (10.9 versus 9.4 percent) during the follow-up period.
“An unplanned interim analysis did not show a significantly higher all-cause mortality rate with paclitaxel-coated devices during one to four years of follow-up,” the authors write.
One author disclosed financial ties to a medical device company.
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