Research finds no association between paclitaxel-coated devices and mortality risk in patients with PAD

Sahil A Parikh, Columbia University Irving Medical Center, New York, NY, USA, and colleagues presented an updated analysis of deaths using the most complete and current data available from pivotal trials of paclitaxel-coated versus control devices.

The patient-level pooled analysis included ten trials comparing paclitaxel-coated versus control devices. Cox regression models were used to assess the effect of paclitaxel exposure on mortality risk in both intention-to-treat (ITT; primary analysis) and three as-treated analysis sets accounting for treatment group crossover at the index procedure and over time. The researchers also evaluated the effect of paclitaxel dose and baseline covariates.

The researchers reported the following findings:

· 2666 participants were included and followed for a median of 4·9 years.

· There was no significant increase in deaths for patients treated with paclitaxel-coated devices. This was true in the ITT analysis (hazard ratio [HR] 1·14), the as-treated analysis (HR 1·13), and in two crossover analyses: 1·07 when late crossovers were censored and 1·04 when crossovers were analysed from the date of paclitaxel exposure.

· There was no significant effect of paclitaxel dose on mortality risk.

"Our findings revealed no association between paclitaxel-coated device exposure and risk of death," the researchers concluded, "providing reassurance to physicians, patients, and regulators on the safety of paclitaxel-coated devices."

Reference:

Parikh, S. A., Schneider, P. A., Mullin, C. M., Rogers, T., & Gray, W. A. (2023). Mortality in randomised controlled trials using paclitaxel-coated devices for femoropopliteal interventional procedures: An updated patient-level meta-analysis. The Lancet, 402(10415), 1848-1856. https://doi.org/10.1016/S0140-6736(23)02189-X