From the Division of Epidemiology and Community Health, School of Public Health (A.A., L.G.S.B., R.F.M., P.L.L., K.L.), University of Minnesota, Minneapolis; and Cardiovascular Division, Department of Medicine (L.Y.C.) and Department of Neurology (K.L.), University of Minnesota Medical School, Minneapolis.
Stroke. 2014 Aug;45(8):2286-91. doi: 10.1161/STROKEAHA.114.006016. Epub 2014 Jul 3.
In randomized trials, patients with atrial fibrillation (AF) receiving dabigatran, a direct oral anticoagulant, had lower risk of intracranial bleeding (ICB) than those on warfarin. However, concerns exist about potential worse outcomes in dabigatran users if bleeding occurs, given the lack of approved reversal agents. Thus, we examined in-hospital mortality in AF patients with ICB being treated with dabigatran versus warfarin in a real-world population in the United States.
We analyzed healthcare utilization claims in the Truven Health Marketscan Research Databases. The study sample included patients with AF admitted to a hospital with a primary diagnosis of ICB. Information on medications, inpatient, and outpatient diagnoses was obtained from available claims. Propensity score-adjusted risk ratios and 95% confidence intervals of in-hospital mortality comparing current users of dabigatran versus warfarin were estimated using relative risk regression.
Among 2391 AF patients admitted with ICB (2290 on warfarin, 101 on dabigatran), 531 died during their admission. In-hospital mortality was similar in those treated with warfarin (22%) or dabigatran (20%). Compared with warfarin users, the propensity score-adjusted risk ratio (95% confidence interval) of mortality in dabigatran users was 0.93 (0.62-1.37). Associations were similar across different ICB subtypes (intracerebral hemorrhage, subarachnoid hemorrhage, and subdural hematoma).
In this sample of AF patients with ICB on oral anticoagulants, dabigatran was not associated with higher in-hospital mortality compared with warfarin. Hence, reluctance to use dabigatran because of a lack of approved reversal agents is not supported by our results.
在随机试验中，接受直接口服抗凝剂达比加群的房颤（AF）患者颅内出血（ICH）风险低于华法林组。然而，鉴于缺乏获批的逆转剂，ICH 患者如果发生出血，达比加群使用者可能存在预后更差的风险。因此，我们在美国真实世界人群中研究了接受达比加群与华法林治疗的 AF 合并 ICH 患者的院内死亡率。
我们分析了 Truven Health Marketscan 研究数据库中的医疗保健利用索赔数据。研究样本包括因 ICH 初诊住院的 AF 患者。药物、住院和门诊诊断信息来自可用的索赔。使用相对风险回归估计比较达比加群与华法林当前使用者的院内死亡率的倾向评分调整风险比和 95%置信区间。
2391 例因 ICH 住院的 AF 患者（华法林 2290 例，达比加群 101 例）中，531 例在住院期间死亡。华法林（22%）或达比加群（20%）治疗患者的院内死亡率相似。与华法林使用者相比，达比加群使用者的死亡率倾向评分调整风险比（95%置信区间）为 0.93（0.62-1.37）。ICH 不同亚型（脑实质内出血、蛛网膜下腔出血和硬脑膜下血肿）之间的关联相似。
在该口服抗凝剂治疗的 AF 合并 ICH 患者样本中，与华法林相比，达比加群并未导致更高的院内死亡率。因此，我们的结果不支持因缺乏获批的逆转剂而不愿使用达比加群的观点。
