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

The study found no significant increase in mortality between the paclitaxel-coated and control devices in both the intention-to-treat and as-treated analyses groups.

Several randomized controlled trials (RCTs) and real-world studies have supported the safety of paclitaxel-coated devices for treating femoropopliteal occlusive disease. However, a 2018 summary-level meta-analysis raised concerns about increased mortality risk for paclitaxel-coated devices compared with uncoated control devices.

Numerous randomised clinical trials and real-world studies have supported the safety of paclitaxel-coated devices for the treatment of femoropopliteal occlusive disease. However, a 2018 summary-level meta-analysis suggested an increased mortality risk for paclitaxel-coated devices compared with uncoated control devices. Despite methodological limitations of these meta-analyses, notices were issued by regulatory bodies worldwide that the use of paclitaxel-coated devices should be restricted for femoropopliteal occlusive disease.

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