Background

Idarucizumab reverses the anticoagulant effect of dabigatran, but few comparative studies have reported on clinical outcomes with idarucizumab.

Objective

Our objective was to determine the effect of idarucizumab on clinical outcomes.

Methods

We conducted a retrospective cohort study in a nationally representative sample of hospitals in the United States. The study population included adults ≥ 18 years who were hospitalized for dabigatran-associated major bleeding between January 1, 2015 and December 31, 2017. We compared idarucizumab-exposed patients to the unexposed group. Our primary outcome of interest was in-hospital mortality.

Results

We included 266 exposed and 1345 non-exposed participants across 271 hospitals. Among participants with gastrointestinal bleeding, there was no statistically significant difference in the odds of in-hospital mortality [9/153 (5.9%) vs 37/1124 (3.3%); adjusted odds ratio = 1.39, 95% confidence interval 0.51–3.45] between the idarucizumab-exposed and non-exposed groups. Among participants with intracranial bleeding, there was an excess of in-hospital mortality [13/112 (11.6%) vs 6/217 (2.8%)] associated with idarucizumab exposure, but limitations include sparse data and the inability to rule out residual confounding or confounding by disease severity.

Conclusions

Among a large nationally representative sample of adult patients with dabigatran-associated major bleeding in the United States, we found no difference in in-hospital mortality among patients with gastrointestinal bleeding associated with idarucizumab exposure. An excess risk of in-hospital mortality associated with idarucizumab exposure among participants with intracranial bleeding deserves further exploration.

中文翻译：

---

与伊达珠单抗相关的现实结果：基于人群的回顾性队列研究。

背景

伊达珠单抗逆转达比加群的抗凝作用，但很少有比较研究报道伊达珠单抗的临床疗效。

目的

我们的目标是确定依达珠单抗对临床结果的影响。

方法

我们在美国具有全国代表性的医院样本中进行了一项回顾性队列研究。研究人群包括2015年1月1日至2017年12月31日因达比加群相关大出血住院的≥18岁成年人。我们将暴露于依达珠单抗的患者与未暴露组进行了比较。我们感兴趣的主要结果是院内死亡率。

结果

我们纳入了271所医院中的266位暴露者和1345位未暴露者。在胃肠道出血患者中，住院死亡率的差异无统计学意义[9/153（5.9％）vs 37/1124（3.3％）；依达西珠单抗暴露组和未暴露组之间的校正比值比= 1.39，95％置信区间0.51–3.45]。在颅内出血参与者中，与依达珠单抗暴露相关的院内死亡率过高[13/112（11.6％）比6/217（2.8％）]，但局限性包括稀疏数据和无法排除残留混杂因素或因疾病严重程度而混淆。

结论

在美国全国范围内具有达比加群相关的大出血成年患者的全国代表样本中，我们发现与依达珠单抗暴露相关的胃肠道出血患者的院内死亡率无差异。颅内出血参与者中与依达珠单抗暴露有关的院内死亡风险过高，值得进一步探讨。