Scholarlink

Introduction <p>Fibrinogen levels may influence the effect of intravenous thrombolysis. We aimed to investigate the efficacy and safety of tenecteplase across different baseline fibrinogen levels in acute ischaemic stroke due to large vessel occlusion (LVO) in the extended time window.</p> Methods <p>We performed a post hoc analysis of the Tenecteplase Reperfusion Therapy in Acute Ischaemic Cerebrovascular Events-III (TRACE-III) trial. Patients who presented within 4.5 to 24&#xa0;h after symptom onset with anterior LVO, salvageable brain tissue, and no access to endovascular thrombectomy were randomised (1:1) to receive either 0.25&#xa0;mg/kg tenecteplase or standard medical treatment. We categorised patients into groups with non-elevated fibrinogen (≤ 4.0&#xa0;g/L) and elevated fibrinogen levels (&gt; 4.0&#xa0;g/L). The primary outcome was the absence of disability, which was defined as a score of 0 to 1 on the modified Rankin scale (mRS) at 90&#xa0;days. The safety outcomes were symptomatic intracranial haemorrhage (sICH) within 36&#xa0;h and all-cause mortality within 90&#xa0;days.</p> Results <p>We included 498 of the 516 patients in the TRACE-III trial who had baseline fibrinogen data. Among them, 426 (85.5%) had non-elevated fibrinogen, and 72 (14.5%) had elevated fibrinogen. Compared with standard medical treatment, tenecteplase significantly increased the proportion of mRS scores of 0–1 at 90&#xa0;days among patients with non-elevated fibrinogen (35.0% vs. 25.7%; relative rate [RR] 1.55; 95% confidence interval [CI] 1.03–2.37; <i>P</i> = 0.04). No significant difference was observed in those with elevated fibrinogen (16.7% vs. 11.1%; RR 1.60; 95%&#xa0;CI 0.42–6.78; <i>P</i> = 0.50). Safety outcomes were similar between the two treatment groups across fibrinogen categories.</p> Conclusions <p>Among patients with LVO presenting within 4.5 to 24&#xa0;h after stroke onset, those with non-elevated fibrinogen levels may receive greater benefit from tenecteplase in reducing disability risk without increasing the incidence of sICH, compared to those with elevated fibrinogen levels.</p> <p>TRACE-III Trial registration: ClinicalTrials.gov identifier, NCT05141305.</p>

错误：搜索内容不能为空，请输入英文关键词
错误：关键词超出字数限制，请精简
高级检索

Effects of Fibrinogen on Tenecteplase Treatment in Acute Ischaemic Stroke After 4.5 Hours of Symptom Onset: A Post Hoc Analysis of the TRACE-III Trial

  • 期刊论文

  • 出版模式：

    开放获取

  • 发表日期：

    2026年5月20日

查看全文
  • Hao Wang,
  • Zhixin Cao,
  • Bruce C. V. Campbell,
  • Aristeidis H. Katsanos,
  • Jinfeng Yin,
  • Marc Fisher,
  • Yongjun Wang,
  • Yunyun Xiong

摘要

Introduction

Fibrinogen levels may influence the effect of intravenous thrombolysis. We aimed to investigate the efficacy and safety of tenecteplase across different baseline fibrinogen levels in acute ischaemic stroke due to large vessel occlusion (LVO) in the extended time window.

Methods

We performed a post hoc analysis of the Tenecteplase Reperfusion Therapy in Acute Ischaemic Cerebrovascular Events-III (TRACE-III) trial. Patients who presented within 4.5 to 24 h after symptom onset with anterior LVO, salvageable brain tissue, and no access to endovascular thrombectomy were randomised (1:1) to receive either 0.25 mg/kg tenecteplase or standard medical treatment. We categorised patients into groups with non-elevated fibrinogen (≤ 4.0 g/L) and elevated fibrinogen levels (> 4.0 g/L). The primary outcome was the absence of disability, which was defined as a score of 0 to 1 on the modified Rankin scale (mRS) at 90 days. The safety outcomes were symptomatic intracranial haemorrhage (sICH) within 36 h and all-cause mortality within 90 days.

Results

We included 498 of the 516 patients in the TRACE-III trial who had baseline fibrinogen data. Among them, 426 (85.5%) had non-elevated fibrinogen, and 72 (14.5%) had elevated fibrinogen. Compared with standard medical treatment, tenecteplase significantly increased the proportion of mRS scores of 0–1 at 90 days among patients with non-elevated fibrinogen (35.0% vs. 25.7%; relative rate [RR] 1.55; 95% confidence interval [CI] 1.03–2.37; P = 0.04). No significant difference was observed in those with elevated fibrinogen (16.7% vs. 11.1%; RR 1.60; 95% CI 0.42–6.78; P = 0.50). Safety outcomes were similar between the two treatment groups across fibrinogen categories.

Conclusions

Among patients with LVO presenting within 4.5 to 24 h after stroke onset, those with non-elevated fibrinogen levels may receive greater benefit from tenecteplase in reducing disability risk without increasing the incidence of sICH, compared to those with elevated fibrinogen levels.

TRACE-III Trial registration: ClinicalTrials.gov identifier, NCT05141305.