Paclitaxel Exposure and Dosage of Drug-coated Devices for the Treatment of Femoropopliteal Peripheral Artery Disease

Abstract

The role of paclitaxel in the treatment of femoropopliteal peripheral arterial disease is currently ambiguous. A summary-level meta-analysis of randomised trials published in 2018 demonstrated that paclitaxel-coated devices were associated with an increased all-cause mortality in those who underwent treatment at 2 years and 5 years. Further evaluation has been undertaken to establish whether there is a specific dose response, mechanism or reproducible signal. At this time, there has been no confirmation of dose response, as was initially asserted by the summary-level meta-analysis. No mechanism of harm has been identified. Although an association with increased mortality has been confirmed by patient-level meta-analysis, the strength of the signal has been inconsistent. The information suggests there is only an association between paclitaxel-coated devices and increased all-cause mortality, not causation. The authors encourage additional studies designed to follow long-term results after treatment with paclitaxel-coated devices, using real patient data, before a conclusion can be made