Department of Family Medicine and Community Health and Meyers Primary Care Institute, University of Massachusetts Medical School, 55 Lake Ave North, Worcester, MA, 01655-0002, USA.
Department of Medicine, Pulmonary and Critical Care, Albany Medical College, Albany, NY, USA.
Am J Cardiovasc Drugs. 2020 Apr;20(2):161-168. doi: 10.1007/s40256-019-00360-6.
Idarucizumab reverses the anticoagulant effect of dabigatran, but few comparative studies have reported on clinical outcomes with idarucizumab.
Our objective was to determine the effect of idarucizumab on clinical outcomes.
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.
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.
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.
依达鲁单抗可逆转达比加群的抗凝作用，但很少有比较研究报告依达鲁单抗的临床结局。
我们旨在确定依达鲁单抗对临床结局的影响。
我们在美国一个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 日期间因达比加群相关大出血住院的年龄≥18 岁的成年人。我们将依达鲁单抗暴露患者与未暴露组进行比较。我们关注的主要结局是住院死亡率。
我们纳入了 271 家医院的 266 名暴露患者和 1345 名未暴露患者。在胃肠道出血的患者中，依达鲁单抗暴露组与未暴露组的住院死亡率无统计学显著差异[9/153（5.9%）vs. 37/1124（3.3%）；调整后的优势比=1.39，95%置信区间 0.51-3.45]。在颅内出血的患者中，依达鲁单抗暴露与住院死亡率升高相关[13/112（11.6%）vs. 6/217（2.8%）]，但存在数据稀疏和无法排除残留混杂或疾病严重程度混杂的局限性。
在一项具有全国代表性的美国达比加群相关大出血成年患者大型样本中，我们发现依达鲁单抗暴露与胃肠道出血相关的患者的住院死亡率无差异。依达鲁单抗暴露与颅内出血患者的住院死亡率升高相关，值得进一步探讨。
