OBJECTIVES The aim of the present study was to quantify the probability of increased mortality with paclitaxel compared with control in a dataset of 28 randomized controlled trials. BACKGROUND Analysis of data from 28 randomized controlled trials using conventional null-hypothesis statistical testing has produced the unexpected finding of a 68% increase in mortality at 2 years and a 93% increase at 3 to 5 years after using paclitaxel-eluting balloons and stents to treat femoropopliteal arterial disease, but no biologic explanation for increased mortality has been identified. METHODS A Bayesian sequential model was developed to quantify the probability of increased mortality 1, 2, and 3 to 5 years after treatment, and p values were replaced with meta-analytic Bayes factors (BFs), which provide decisive evidence at values >100 and very strong evidence at values of 32 to 100. RESULTS The evidence for increased mortality at 1 year (BF = 0.02), 2 years (BF = 8.5), and 3 to 5 years (BF = 14.6) was less than conclusive. All-cause mortality at 1 year was similar between the paclitaxel and control arms at 1 year (odds ratio: 0.92; 95% Bayesian credible interval: 0.53 to 1.53) and 2 years (odds ratio: 1.23; 95% Bayesian credible interval: 0.84 to 1.71) but was increased at 3 to 5 years (odds ratio: 1.43; 95% Bayesian credible interval: 1.01 to 1.90). CONCLUSIONS This study finds some support for increased mortality after using paclitaxel-eluting devices in femoropopliteal arterial disease, but the evidence is not unequivocal and may not sway skeptical investigators concerned about causation, unreported studies, or the post hoc analysis of trials underpowered for mortality.

中文翻译：

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外周紫杉醇洗脱装置的死亡率声明的贝叶斯因子荟萃分析。

目的本研究的目的是在28个随机对照试验的数据集中，量化紫杉醇与对照组相比死亡率增加的可能性。背景技术使用常规零假设统计测试对来自28个随机对照试验的数据进行分析后，意外发现在使用紫杉醇洗脱球囊和支架治疗后2年死亡率增加了68％，3至5年死亡率增加了93％。可以治疗股pop动脉疾病，但尚未发现增加死亡率的生物学解释。方法建立贝叶斯序贯模型以量化治疗后1、2和3至5年死亡率增加的可能性，并用荟萃分析贝叶斯因子（BFs）代替p值，该值在≥ 100和非常有力的证据表明值在32到100之间。结果1年（BF = 0.02），2年（BF = 8.5）和3至5年（BF = 14.6）死亡率增加的证据不足以得出结论。紫杉醇和对照组在1年时的全因死亡率相似（1年（几率：0.92； 95％贝叶斯可信区间：0.53至1.53）和2年（几率：1.23； 95％贝叶斯可信区间：0.84））。至1.71），但在3至5年时有所提高（赔率：1.43； 95％贝叶斯可信区间：1.01至1.90）。结论本研究为在股pop动脉疾病中使用紫杉醇洗脱装置后增加的死亡率提供了一定的支持，但证据并不明确，可能不会使怀疑的研究者对因果关系，未报道的研究或对死亡率不足的试验进行事后分析。