Mortality with Paclitaxel-Coated Devices in Peripheral Artery Disease

The results of a recent meta-analysis aroused concern about an increased risk of death associated with the use of paclitaxel-coated angioplasty balloons and stents in lower-limb endovascular interventions for symptomatic peripheral artery disease.
In this randomized trial in which patients with peripheral artery disease received treatment with paclitaxel-coated or uncoated endovascular devices, the results of an unplanned interim analysis of all-cause mortality did not show a difference between the groups in the incidence of death during 1 to 4 years of follow-up. (Funded by the Swedish Research Council and others; ClinicalTrials.gov number, NCT02051088. opens in new tab.)
Author(s)Source
Nordanstig J, James S, Andersson M et al.N Engl J Med 2020; 383:2538-2546
DOI: 10.1056/NEJMoa2005206
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