• Sahil A Parikh, Peter A Schneider, Christopher M Mullin, Tyson Rogers, and William A Gray.
• Columbia University Irving Medical Center, New York, NY, USA. Electronic address: sap2196@cumc.columbia.edu.
• Lancet. 2023 Nov 18; 402 (10415): 184818561848-1856.

BackgroundNumerous 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. This study presents an updated analysis of deaths using the most complete and current data available from pivotal trials of paclitaxel-coated versus control devices.MethodsTen trials comparing paclitaxel-coated versus control devices were included in a patient-level pooled analysis. Cox regression models were used to evaluate the effect of paclitaxel exposure on risk of death 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 effect of paclitaxel dose and baseline covariates were also evaluated.FindingsA total of 2666 participants were included with a median follow-up of 4·9 years. No significant increase in deaths was observed for patients treated with paclitaxel-coated devices. This was true in the ITT analysis (hazard ratio [HR] 1·14, 95% CI 0·93-1·40), the as-treated analysis (HR 1·13, 95% CI 0·92-1·39), and in two crossover analyses: 1·07 (0·87-1·31) when late crossovers were censored and 1·04 (0·84-1·28) when crossovers were analysed from the date of paclitaxel exposure. There was no significant effect of paclitaxel dose on mortality risk.InterpretationThis meta-analysis found no association between paclitaxel-coated device exposure and risk of death, providing reassurance to patients, physicians, and regulators on the safety of paclitaxel-coated devices.FundingBecton Dickinson, Boston Scientific, Cook, Medtronic, Philips, Surmodics, and TriReme Medical.Copyright © 2023 Elsevier Ltd. All rights reserved.

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