{"title":"颅内出血状况对缺血性脑卒中患者INR与死亡率关系的中介作用。","authors":"Yapeng Guo, Lingshan Wu, Zhenxuan Tian, Xu Xu, Jinfu Ma, Changwei Guo, Linyu Li, Jie Yang, Wenjie Zi, Jiacheng Huang, Xianjun Huang","doi":"10.1007/s40120-025-00715-z","DOIUrl":null,"url":null,"abstract":"<p><strong>Introduction: </strong>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.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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).</p><p><strong>Conclusion: </strong>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.</p><p><strong>Trial registration: </strong>URL: http://www.chictr.org.cn ; ChiCTR-INR-17014167.</p>","PeriodicalId":19216,"journal":{"name":"Neurology and Therapy","volume":" ","pages":"881-894"},"PeriodicalIF":3.9000,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12089563/pdf/","citationCount":"0","resultStr":"{\"title\":\"The Mediating Effect of Intracranial Hemorrhage Status on the Relationship between the INR and Mortality in Patients with Ischemic Stroke.\",\"authors\":\"Yapeng Guo, Lingshan Wu, Zhenxuan Tian, Xu Xu, Jinfu Ma, Changwei Guo, Linyu Li, Jie Yang, Wenjie Zi, Jiacheng Huang, Xianjun Huang\",\"doi\":\"10.1007/s40120-025-00715-z\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Introduction: </strong>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.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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).</p><p><strong>Conclusion: </strong>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. 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引用次数: 0
摘要
国际标准化比值(INR)是凝血功能障碍的生物标志物。本研究的目的是评估接受血管内治疗的大血管闭塞(LVO)卒中患者的INR与临床结果之间的关系。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,涉及来自中国55个中心的948例脑卒中患者。我们从BT数据库中提取了INR数据和相关数据,结果测量包括颅内出血(ICH)和90天死亡率。进行了Logistic回归分析,以检查整个患者队列和不同分层亚组的INR与临床结果之间的关系。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(OR 1.65, 95%可信区间CI 1.17-2.33, P =0.005)和90天死亡率增加(OR 1.78, 95% CI 1.17-2.70, P =0.007)有关。中介分析表明,INR与90天死亡风险之间的关联被ICH状态部分中介,中介效应占总关系的11.4%。亚组分析显示不同亚组间无显著差异(P为相互作用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)的左心室卒中患者中监测INR的重要性。INR与90天死亡率之间的关联是通过ICH状态介导的。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预后提供了有价值的指导。试用注册:网址:http://www.chictr.org.cn;chictr -印度卢比17014167。
The Mediating Effect of Intracranial Hemorrhage Status on the Relationship between the INR and Mortality in Patients with Ischemic Stroke.
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.
期刊介绍:
Aims and Scope
Neurology and Therapy aims to provide reliable and inclusive, rapid publication for all therapy related research for neurological indications, supporting the timely dissemination of research with a global reach, to help advance scientific discovery and support clinical practice.
Neurology and Therapy is an international, open access, peer reviewed, rapid publication journal dedicated to the publication of high-quality clinical (all phases), observational, real-world and health outcomes research around the discovery, development, and use of neurological and psychiatric therapies, (also covering surgery and devices). Studies relating to diagnosis, pharmacoeconomics, public health, quality of life, and patient care, management, and education are also welcomed.
The journal is of interest to a broad audience of healthcare professionals and publishes original research, reviews, case reports, trial designs, communications and letters. The journal is read by a global audience and receives submissions from all over the world. Neurology and Therapy will consider all scientifically sound research be it positive, confirmatory or negative data. Submissions are welcomed whether they relate to an international and/or a country-specific audience, something that is crucially important when researchers are trying to target more specific patient populations. This inclusive approach allows the journal to assist in the dissemination of all scientifically and ethically sound research.
Rapid Publication
The journal’s rapid publication timelines aim for a peer review decision within 2 weeks of submission. If an article is accepted, it will be published online 3-4 weeks from acceptance. These rapid timelines are achieved through the combination of a dedicated in-house editorial team, who closely manage article workflow, and an extensive Editorial and Advisory Board who assist with rapid peer review. This allows the journal to support the rapid dissemination of research, whilst still providing robust peer review. Combined with the journal’s open access model, this allows for the rapid and efficient communication of the latest research and reviews to support scientific discovery and clinical practice.
Open Access
All articles published by Neurology and Therapy are open access.
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The journal’s dedicated in-house editorial team offer a personal “concierge service” meaning that authors will always have a personal point of contact able to update them on the status of their manuscript. The editorial team check all manuscripts to ensure that articles conform to the most recent COPE and ICMJE publishing guidelines. This supports the publication of ethically sound and transparent research. We also encourage pre-submission enquiries and are always happy to provide a confidential assessment of manuscripts.
Digital Features and Plain Language Summaries
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Upon acceptance of an article, authors will be required to pay the mandatory Rapid Service Fee of €5250/$6000/£4300. The journal will consider fee discounts and waivers for developing countries and this is decided on a case-by-case basis.
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Upon submission, manuscripts are assessed by the editorial team to ensure they fit within the aims and scope of the journal and are also checked for plagiarism. All suitable submissions are then subject to a comprehensive single-blind peer review. Reviewers are selected based on their relevant expertise and publication history in the subject area. The journal has an extensive pool of editorial and advisory board members who have been selected to assist with peer review based on the afore-mentioned criteria.
At least two extensive reviews are required to make the editorial decision, with the exception of some article types such as Commentaries, Editorials and Letters which are generally reviewed by one member of the Editorial Board. Where reviews conflict, an Editorial Board Member will be contacted for further advice and a presiding decision. Manuscripts are then either accepted, rejected or authors are required to make major or minor revisions (both reviewer comments and editorial comments may need to be addressed. Once a revised manuscript is re-submitted, it is assessed along with the responses to reviewer comments and if it has been adequately revised, it will be accepted for publication. Accepted manuscripts are then copyedited and typeset by the production team before online publication. Appeals against decisions following peer review are considered on a case-by-case basis and should be sent to the journal editor, and authors are welcome to make rebuttals against individual reviewer comments, if appropriate.
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For more information about the journal, including pre-submission enquiries, please contact managing editor Lydia Alborn at lydia.alborn@springer.com.