Nordanstig J, James S, Andersson M, et al. - Because the findings of a recent meta-analysis gave rise to concern regarding an elevated risk of mortality related to the use of paclitaxel-coated angioplasty balloons and stents in lower-limb endovascular interventions for symptomatic peripheral artery disease, researchers analyzed data from a multicenter, randomized, open-label, registry-based clinical trial, by performing an unplanned interim analysis. A total of 2,289 patients had been randomized, at the time of the analysis, to receive treatment with drug-coated devices (the drug-coated–device group, 1149 patients) or were managed with uncoated devices (the uncoated-device group, 1140 patients). In the drug-coated–device group and in the uncoated-device group, the all-cause mortality at 1 year was estimated to be 10.2% (117 patients) and 9.9% (113 patients), respectively. In this randomized trial wherein peripheral artery disease cases were managed with paclitaxel-coated or uncoated endovascular devices, there was no difference in the incidence of death between the groups during 1 to 4 years of follow-up, as revealed in an unplanned interim analysis of all-cause mortality.