Renal dysfunction and outcomes for thrombolysis-treated stroke beyond 4.5 hours: Trace-Ⅲ post hoc analysis

IF 1.8 4区医学 Q3 NEUROSCIENCES

Journal of Stroke & Cerebrovascular Diseases Pub Date : 2025-07-29 DOI:10.1016/j.jstrokecerebrovasdis.2025.108409

Lixia Zong MD, PhD , Liyuan Wang MD , Aoming Jin PhD , Yujie Ma MD , Xueyan Feng MD, PhD , Hao Wang MD , Ziran Wang MD , Hongguo Dai MD , Fengyuan Che MD , Lihua Wang MD, PhD , Li Zhou MD , Yunyun Xiong MD, PhD , Yongjun Wang MD

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引用次数: 0

Abstract

Objective

Concerns regarding bleeding risks have limited the use of intravenous thrombolysis in acute ischemic stroke (AIS) patients with renal dysfunction (RD). This study investigated the impact of RD on the efficacy and safety of Tenecteplase (TNK) thrombolysis in AIS patients with large vessel occlusions (LVO) beyond the 4.5 h window.

Methods

This post hoc analysis of the Tenecteplase Reperfusion Therapy in Acute Ischemic Cerebrovascular Events–III (TRACE-III) Trial included 510 patients with LVO (4.5–24 h from onset) randomized to TNK (0.25 mg/kg) or standard medical treatment (SMT). Renal function was categorized as normal (eGFR ≥90 mL/min/1.73 m²), mild (eGFR 60–89), or moderate-to-severe RD (eGFR <60). Primary efficacy outcome was 90-day excellent functional outcome (modified Rankin Scale [mRS] 0-1). Safety outcomes included symptomatic intracerebral hemorrhage (sICH), mortality and moderate or severe bleeding within 90 days. Multivariable regression and linear models were used to assess treatment effects across eGFR strata.

Results

In normal renal function patients (n = 410), TNK showed numerically higher excellent outcomes (32.3 % vs. 24.2 %, RR=1.28, 95 % CI 0.94∼1.75) and improved secondary outcomes (neurological improvement, as defined by NIHSS score reduction at 24 h/72 h/7 d and reperfusion rates), albeit with increased sICH (3.2 % vs. 1.1 %, p = 0.05). For mild RD (n = 82), TNK demonstrated a non-significant trend toward better functional outcomes (40.6 % vs. 26.0 %, RR=1.52, 95 % CI 0.78∼2.96). In moderate-to-severe RD (n = 18), outcomes were inconclusive due to limited sample size.

Conclusion

TNK may benefit late-window LVO stroke patients with normal or mildly impaired renal function. The risk-benefit profile in moderate-to-severe RD remains uncertain, highlighting the need for larger prospective studies in this high-risk population.

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超过4.5小时溶栓治疗中风的肾功能障碍和结果：追踪-Ⅲ事后分析。

目的：对出血风险的担忧限制了急性缺血性卒中（AIS）合并肾功能不全（RD）患者静脉溶栓的使用。本研究探讨了RD对AIS大血管闭塞（LVO）患者超过4.5小时窗期使用Tenecteplase （TNK）溶栓的疗效和安全性的影响。方法：对Tenecteplase再灌注治疗急性缺血性脑血管事件- iii （TRACE-III）试验进行事后分析，纳入510例LVO患者（发病后4.5-24小时），随机接受TNK （0.25 mg/kg）或标准药物治疗（SMT）。肾功能被分类为正常（eGFR≥90 mL/min/1.73m²）、轻度（eGFR 60-89）或中度至重度RD (eGFR结果：在肾功能正常的患者（n=410）中，TNK表现出更高的数值上的优秀结局（32.3% vs. 24.2%， RR=1.28, 95% CI 0.94 ~ 1.75）和改善的次要结局（神经系统改善，根据NIHSS评分在24小时/72小时/7d和再灌注率降低定义），尽管siich增加（3.2% vs. 1.1%, p=0.05）。对于轻度RD (n=82)， TNK显示出改善功能结果的非显著趋势（40.6% vs. 26.0%， RR=1.52, 95% CI 0.78 ~ 2.96）。在中度至重度RD （n=18）中，由于样本量有限，结果不确定。结论：TNK可使肾功能正常或轻度受损的晚期左心室卒中患者受益。中度至重度RD的风险-收益情况仍不确定，因此需要在这一高危人群中进行更大规模的前瞻性研究。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Journal of Stroke & Cerebrovascular Diseases Medicine-Surgery

CiteScore

5.00

自引率

4.00%

发文量

583

审稿时长

62 days

期刊介绍： The Journal of Stroke & Cerebrovascular Diseases publishes original papers on basic and clinical science related to the fields of stroke and cerebrovascular diseases. The Journal also features review articles, controversies, methods and technical notes, selected case reports and other original articles of special nature. Its editorial mission is to focus on prevention and repair of cerebrovascular disease. Clinical papers emphasize medical and surgical aspects of stroke, clinical trials and design, epidemiology, stroke care delivery systems and outcomes, imaging sciences and rehabilitation of stroke. The Journal will be of special interest to specialists involved in caring for patients with cerebrovascular disease, including neurologists, neurosurgeons and cardiologists.