Neutrophil to Lymphocyte Ratio and Neurological Outcome in Ischemic Stroke at 4.5 to 24 Hours: A Post Hoc Analysis of TRACE-III Trial.

IF 4.7 3区医学 Q1 CLINICAL NEUROLOGY

Neurology and Therapy Pub Date : 2026-10-16 DOI:10.1007/s40120-026-01060-5

Manjun Hao, Yujie Ma, Lihua Wang, Aoming Jin, Zhe Kang Law, Bruce C V Campbell, Lee H Schwamm, Mark W Parsons, Marc Fisher, Yuming Xu, Anding Xu, Zhixin Cao, Liyuan Wang, Shuangzhe Wu, Yongjun Wang, Yunyun Xiong

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引用次数: 0

Abstract

Introduction: Whether neutrophil to lymphocyte ratio (NLR), as a marker of increased inflammatory response, modifies the efficacy and safety of tenecteplase is uncertain in patients 4.5-24 h after stroke onset. We investigated this in the Tenecteplase Reperfusion Therapy in Acute Ischemic Cerebrovascular Events-III (TRACE-III) trial.

Methods: TRACE-III was a phase 3, multicenter, prospective, open-label, randomized, blinded-endpoint trial that enrolled 516 patients from 58 centers in China between January 2022 and November 2023. Patients had anterior large vessel occlusion and evidence of salvageable brain tissue on perfusion imaging, presented 4.5-24 h after symptom onset, and were randomized 1:1 to intravenous tenecteplase (intervention) or standard medical treatment (control). The primary efficacy and safety outcomes were modified Rankin scale score of 0-1 at 90 days and symptomatic intracranial hemorrhage or death, respectively. This post hoc analysis in 513 patients with complete admission NLR data compared outcomes in patients with elevated NLR (> first quartile) and non-elevated NLR (≤ first quartile).

Results: In the elevated NLR group (> 3.0), tenecteplase was associated with increased functional independence (61 [30.2%] vs. 36 [19.6%]; adjusted relative rate [aRR] 1.51; 95% confidence interval [CI] 1.05-2.17; P = 0.03) compared to standard medical treatment. This benefit was not observed in the non-elevated NLR group (26 [41.9%] vs. 25 [38.5%]; aRR 1.12; 95% CI 0.73-1.73). Safety outcomes did not differ in either the elevated or non-elevated NLR groups.

Conclusion: Baseline NLR may provide a potential signal for differential treatment response to intravenous tenecteplase in patients with acute ischemic stroke, although these exploratory findings require further validation in independent studies.

Trial registration: TRACE-III is registered with ClinicalTrials.gov, NCT05141305.

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中性粒细胞/淋巴细胞比率和缺血性卒中4.5 - 24小时的神经转归：TRACE-III试验的事后分析

作为炎症反应增加的标志，中性粒细胞与淋巴细胞比值（NLR）是否会改变替奈普酶在卒中发作后4.5-24小时的疗效和安全性尚不确定。我们在急性缺血性脑血管事件的替奈普酶再灌注治疗- iii （TRACE-III）试验中对此进行了研究。TRACE-III是一项3期、多中心、前瞻性、开放标签、随机、盲终点试验，于2022年1月至2023年11月在中国58个中心招募了516名患者。患者前路大血管闭塞，灌注显像显示脑组织可抢救，症状出现后4.5 ~ 24 h出现，按1:1随机分为静脉注射替奈普酶组（干预组）和标准药物组（对照组）。主要疗效和安全性指标分别为90天修正Rankin评分0-1分和症状性颅内出血或死亡。对513例具有完整入院NLR数据的患者进行事后分析，比较NLR升高（第1四分位数）和非NLR升高（≤第1四分位数）患者的结果。结果：在NLR升高组（> 3.0）中，与标准药物治疗相比，tenecteplase与功能独立性增加相关（61 [30.2%]vs. 36[19.6%]；调整相对率[aRR] 1.51； 95%可信区间[CI] 1.05-2.17; P = 0.03）。非NLR升高组未观察到这种获益（26[41.9%]对25 [38.5%];aRR 1.12; 95% CI 0.73-1.73）。NLR升高组和非升高组的安全性结果没有差异。结论：基线NLR可能为急性缺血性卒中患者静脉注射替奈普酶治疗的差异反应提供潜在信号，尽管这些探索性发现需要在独立研究中进一步验证。试验注册：TRACE-III在ClinicalTrials.gov注册，编号NCT05141305。

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来源期刊

Neurology and Therapy CLINICAL NEUROLOGY-

CiteScore

5.40

自引率

8.10%

发文量

103

审稿时长

6 weeks

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. 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