颅内出血状态在缺血性脑卒中患者国际标准化比值（INR）与死亡率关系中的中介作用
The Mediating Effect of Intracranial Hemorrhage Status on the Relationship between the INR and Mortality in Patients with Ischemic Stroke.
作者信息
Guo Yapeng, Wu Lingshan, Tian Zhenxuan, Xu Xu, Ma Jinfu, Guo Changwei, Li Linyu, Yang Jie, Zi Wenjie, Huang Jiacheng, Huang Xianjun
机构信息
Department of Neurology, Yijishan Hospital of Wannan Medical College, 2# Zheshan West Road, Wuhu, 241001, Anhui, China.
Department of Neurology, Xinqiao Hospital, The Second Affiliated Hospital, Army Medical University (Third Military Medical University), Shapingba District, No. 183 Xinqiao Main St, Chongqing, 400037, China.
出版信息
Neurol Ther. 2025 Jun;14(3):881-894. doi: 10.1007/s40120-025-00715-z. Epub 2025 Apr 9.
INTRODUCTION
The international normalized ratio (INR) is a biomarker of coagulopathy. The objective of this study was to assess the relationship between the INR and clinical outcomes in patients with large vessel occlusion (LVO) stroke who received endovascular therapy.
METHODS
The RESCUE BT trial was a multicenter, randomized, double-blind, placebo-controlled clinical trial involving 948 stroke patients from 55 centers across China. We extracted INR data and related data from the BT database, with outcome measures comprising intracranial hemorrhage (ICH) and 90-day mortality. Logistic regression analysis was conducted to examine the associations between the INR and clinical outcomes in the entire patient cohort and across different stratified subgroups.
RESULTS
A total of 885 patients met the study criteria, with 672 exhibiting a normal INR and 213 showing an elevated INR. Multivariable analysis indicated that an elevated INR was linked to an increased risk of ICH (OR 1.65, 95% confidence interval CI 1.17-2.33, P =0.005) and 90-day mortality (OR 1.78, 95% CI 1.17-2.70, P =0.007). Mediation analysis indicated that the association between the INR and 90-day mortality risk was partially mediated by ICH status, with the mediation effect contributing 11.4% to the overall relationship. Subgroup analyses revealed no significant differences between the different subgroups (P for interaction > 0.05). In patients receiving tirofiban, an elevated INR was more strongly associated with an increased 90-day mortality rate (OR 7.75, 95% CI 1.42-42.33, P =0.018).
CONCLUSION
Our findings underscore the critical importance of INR monitoring in patients with LVO stroke undergoing endovascular treatment (EVT). The association between the INR and 90-day mortality was mediated through ICH status. The use of tirofiban strengthened the associated between an elevated INR and a higher 90-day mortality rate. These insights offer valuable guidance for optimizing patient outcomes.
TRIAL REGISTRATION
URL: http://www.chictr.org.cn ; ChiCTR-INR-17014167.
引言
国际标准化比值（INR）是凝血病的生物标志物。本研究的目的是评估接受血管内治疗的大血管闭塞（LVO）性卒中患者的INR与临床结局之间的关系。
方法
RESCUE BT试验是一项多中心、随机、双盲、安慰剂对照的临床试验，涉及中国55个中心的948例卒中患者。我们从BT数据库中提取了INR数据和相关数据，结局指标包括颅内出血（ICH）和90天死亡率。进行逻辑回归分析，以检验整个患者队列以及不同分层亚组中INR与临床结局之间的关联。
结果
共有885例患者符合研究标准，其中672例INR正常，213例INR升高。多变量分析表明，INR升高与ICH风险增加（比值比[OR] 1.65，95%置信区间[CI] 1.17 - 2.33，P = 0.005）和90天死亡率增加（OR 1.78，95% CI 1.17 - 2. seven0，P = 0.007）相关。中介分析表明，INR与90天死亡风险之间的关联部分由ICH状态介导，中介效应占总体关系的11.4%。亚组分析显示不同亚组之间无显著差异（交互作用P>0.05）。在接受替罗非班治疗的患者中，INR升高与90天死亡率增加的相关性更强（OR 7.75，95% CI 1.42 - 42.33，P = 0.018）。
结论
我们的研究结果强调了在接受血管内治疗（EVT）的LVO性卒中患者中监测INR的至关重要性。INR与90天死亡率之间的关联通过ICH状态介导。替罗非班的使用强化了INR升高与90天死亡率升高之间的相关性。这些见解为优化患者结局提供了有价值的指导。
试验注册
网址：http://www.chictr.org.cn；中国临床试验注册中心编号：ChiCTR-INR-17014167 。
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