Effect of Baseline ASPECTS on Tenecteplase Efficacy Before Thrombectomy in Acute Large-Vessel Occlusion Stroke: A Post Hoc Analysis of the BRIDGE-TNK Randomized Trial.

The aim of this study was to evaluate whether the baseline ischemic extent, measured by the Alberta Stroke Program Early Computed Tomography Score (ASPECTS), modifies outcomes of intravenous tenecteplase administered before endovascular thrombectomy.

本研究旨在评估基线缺血范围（通过阿尔伯塔中风项目早期计算机断层扫描评分（ASPECTS）测量）是否改变了在血管内血栓切除术前使用静脉注射替奈普酶的结果。

Methods

This was a post hoc analysis of the BRIDGE-TNK (thrombectomy with vs without rhTNK-tPA in stroke) trial, conducted across China from May 2022 to September 2024.

这是对中国从2022年5月到2024年9月进行的BRIDGE-TNK（使用rhTNK-tPA与不使用rhTNK-tPA进行血栓切除术的中风）试验的事后分析。

We compared the efficacy and safety of intravenous tenecteplase plus thrombectomy vs thrombectomy alone in acute large-vessel occlusion stroke patients within 4.5 hours of last known well, stratified by baseline ASPECTS (<8 vs 8-10).

我们比较了在最后已知良好时间点4.5小时内接受静脉注射替奈普酶加血栓切除术与仅血栓切除术治疗急性大血管闭塞中风患者的疗效和安全性，根据基线ASPECTS（<8 vs 8-10）进行分层。

The outcomes included 90-day functional independence (modified Rankin Scale score of 0-2), 48-hour symptomatic intracranial hemorrhage (sICH), and 90-day mortality.

结果包括90天功能独立（改良Rankin量表评分为0-2）、48小时症状性颅内出血（sICH）和90天死亡率。

Regression models incorporating a treatment-by-ASPECTS interaction term were used for analysis.

使用包含治疗与ASPECTS相互作用项的回归模型进行分析。

Results

Among 550 patients, 241 (43.8%) had ASPECTS <8 (median [interquartile range, IQR] age, 69 [61-77] years; 56.4% male) and 309 had ASPECTS 8-10 (median [IQR] age, 70 [61-77] years; 59.5% male).

在550名患者中，241名（43.8%）的ASPECTS<8（中位年龄[四分位数间距，IQR]，69[61-77]岁；56.4%为男性），309名的ASPECTS为8-10（中位年龄[IQR]，70[61-77]岁；59.5%为男性）。

The rate of functional independence was significantly higher in the tenecteplase plus thrombectomy group than in the thrombectomy-alone group in the ASPECTS <8 subgroup (adjusted risk ratio [aRR], 1.67; 95% CI 1.18-2.35), but not in the ASPECTS 8-10 subgroup (aRR, 0.99; 95% CI 0.84-1.17; pinteraction = 0.007).

在ASPECTS<8亚组中，静脉注射替奈普酶加血栓切除术组的功能独立率显著高于仅血栓切除术组（调整后的风险比[aRR]，1.67；95% CI 1.18-2.35），但在ASPECTS 8-10亚组中并非如此（aRR，0.99；95% CI 0.84-1.17；pinteraction = 0.007）。

Rates of sICH did not differ significantly between treatment groups in either ASPECTS subgroups (ASPECTS <8: 10.0% vs 11.2%; ASPECTS 8-10: 7.5% vs 2.8%; pinteraction = 0.11).

在ASPECTS亚组中，两组治疗组之间的症状性颅内出血（sICH）发生率没有显著差异（ASPECTS <8: 10.0% 对比 11.2%；ASPECTS 8-10: 7.5% 对比 2.8%；pinteraction = 0.11）。

Ninety-day mortality was comparable between treatment groups in the ASPECTS <8 subgroup, but numerically higher with tenecteplase plus thrombectomy in the ASPECTS 8-10 subgroup (aRR = 1.89, 95% CI 0.99-3.61, pinteraction = 0.04).

在ASPECTS <8亚组中，90天的死亡率在治疗组之间是可比的，但在ASPECTS 8-10亚组中，使用替奈普酶加血栓切除术的死亡率在数值上更高（aRR = 1.89, 95% CI 0.99-3.61, pinteraction = 0.04）。

Discussion

In this exploratory post hoc analysis, a signal of benefit was observed in patients with ASPECTS <8 who received intravenous tenecteplase before thrombectomy, whereas no functional improvement and possible safety concerns were seen in those with ASPECTS 8-10.

在这项探索性的事后分析中，观察到在ASPECTS <8的患者中，接受静脉注射替奈普酶后再进行血栓切除术的患者有获益的信号，而在ASPECTS 8-10的患者中则没有功能性改善，并且可能存在安全问题。

Prospective confirmation in randomized trials is required before practice change.

在随机试验中进行前瞻性确认之前，尚不能改变实践。

trial_registration_information

ClinicalTrials.gov; Unique identifier: NCT04733742.

ClinicalTrials.gov; 唯一标识符: NCT04733742。