Mortality in randomised controlled trials using paclitaxel-coated devices for femoropopliteal interventional procedures: an updated patient-level meta-analysis - PubMed (original) (raw)

Meta-Analysis

. 2023 Nov 18;402(10415):1848-1856.

doi: 10.1016/S0140-6736(23)02189-X. Epub 2023 Oct 24.

Affiliations

Meta-Analysis

Mortality in randomised controlled trials using paclitaxel-coated devices for femoropopliteal interventional procedures: an updated patient-level meta-analysis

Sahil A Parikh et al. Lancet. 2023.

Abstract

Background: 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. 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.

Methods: Ten 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.

Findings: A 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.

Interpretation: This 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.

Funding: Becton Dickinson, Boston Scientific, Cook, Medtronic, Philips, Surmodics, and TriReme Medical.

Copyright © 2023 Elsevier Ltd. All rights reserved.

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Conflict of interest statement

Declaration of interests SAP serves on the advisory boards for Abbott Vascular, Boston Scientific, Cordis, Medtronic, and Philips; receives institutional research funding from Abbott Vascular, Boston Scientific, Surmodics, TriReme Medical, Shockwave Medical, Reflow Medical, Acotec and Concept Medical; and consults for Terumo, Inari, Penumbra and Canon. SAP has equity in Advanced Nanotherapies, eFemoral, and Encompass Vascular. PAS serves on the advisory boards for Philips, Boston Scientific, and Medtronic; and consults for Cagent, LimFlow, Silk Road Medical, Acotec, Endologix, and Surmodics. TR and CMM are employed by NAMSA, which was funded by an unrestricted grant from the industry consortium. WAG consults for Philips, Medtronic, Boston Scientific, Surmodics, Encompass Vascular, eFemoral, Cagent, Sonovascular, Conformal Medical, Contego Medical, ReValve, Alucent, and Edwards LifeSciences; and holds stock with eFemoral, Encompass Vascular, Xenter, and Reflow Medical.

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