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

中文翻译：

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使用紫杉醇涂层装置进行股腘介入手术的随机对照试验中的死亡率：更新的患者水平荟萃分析

大量随机临床试验和真实世界研究支持紫杉醇涂层装置治疗股腘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，与未涂层的对照器械相比，紫杉醇涂层器械的死亡风险增加。这项研究利用紫杉醇涂层与对照装置的关键试验中可获得的最完整和最新的数据，对死亡进行了更新的分析。患者水平的汇总分析中纳入了十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）和三个治疗分析组中死亡风险的影响，这三个分析组考虑了治疗组在指数程序和时间上的交叉。还评估了紫杉醇剂量和基线协变量的影响。共有 2666 名参与者参与其中，中位随访时间为 4·9 年。使用紫杉醇涂层装置治疗的患者没有观察到死亡人数显着增加。在 ITT 分析（风险比 [HR] 1·14，95% CI 0·93–1·40）和治疗分析（HR 1·13，95% CI 0·92–1·39）中也是如此。 ），以及两个交叉分析：1·07（0·87–1·31），当晚期交叉被审查时；1·04（0·84–1·28），当从紫杉醇暴露之日起分析交叉时。紫杉醇剂量对死亡风险没有显着影响。这项荟萃分析发现紫杉醇涂层器械暴露与死亡风险之间没有关联，这为患者、医生和监管机构对紫杉醇涂层器械的安全性提供了保证。Becton Dickinson、波士顿科学公司、库克、美敦力、飞利浦、Surmodics 和 TriReme Medical。