The most comprehensive analysis of clinical data to date affirming the safety of paclitaxel-coated devices to treat peripheral arterial disease, was published in The Lancet and presented at the TCT conference on Oct. 24, 2023.
The data confirms there is no excess mortality risk associated with paclitaxel-coated devices and just as importantly, no relationship between dose and mortality was identified either.
This patient-level, pooled analysis of pivotal randomized controlled trials, conducted with input from the FDA, provides the most complete and current follow-up data of pivotal studies associated with FDA-approved paclitaxel-coated devices.
With five-year vital status available in 95% of evaluable patients and a comprehensive examination of the impact of treatment-group crossovers, this initiative represents the most complete patient-level analysis to date, or likely to be available in the future.
No association between mortality risk and paclitaxel-coated device exposure or dose was observed in any of the pre-specified analytic approaches.