美国纽约哥伦比亚大学欧文医学中心Sahil A Parikh团队对使用紫杉醇涂层装置进行股骨腘窝介入手术是否增加患者死亡率进行了综合荟萃分析。2023年10月24日出版的《柳叶刀》杂志发表了这项成果。

许多随机临床试验和真实世界的研究都支持紫杉醇涂层装置治疗股腘动脉闭塞性疾病的安全性。然而，2018年的一项汇总级荟萃分析表明，与未涂覆的对照装置相比，紫杉醇涂层装置的死亡率增加。该研究使用紫杉醇涂层与对照装置的关键试验中最完整和最新的数据，对死亡进行了最新分析。

研究组在患者水平的汇总分析中纳入了10项比较紫杉醇涂层与对照装置的试验。Cox回归模型用于评估紫杉醇暴露对意向治疗（ITT；主要分析）和三个治疗后分析组死亡风险的影响，这三个分析组在指标程序和时间上考虑了治疗组的交叉。还评估了紫杉醇剂量和基线协变量的影响。

共纳入2666名参与者，中位随访时间为4.9年。使用紫杉醇涂层装置治疗的患者的死亡人数没有显著增加。ITT分析（危险比[HR]1.14）、治疗前分析（HR 1.3）和两项交叉分析中都是如此：从紫杉醇暴露之日起，对晚期交叉进行审查时为1.07，对交叉进行分析时为1.04。紫杉醇剂量对死亡率没有显著影响。

这项荟萃分析发现紫杉醇涂层装置暴露与死亡风险之间没有关联，该研究结果为患者、医生和监管机构提供了紫杉醇涂层器械安全性的保证。

附：英文原文

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

Author: Sahil A Parikh, Peter A Schneider, Christopher M Mullin, Tyson Rogers, William A Gray

Issue&Volume: 2023-10-24

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.

DOI: 10.1016/S0140-6736(23)02189-X

Source: https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(23)02189-X/abstract