Adjunctive Intra-Arterial Alteplase After Successful Thrombectomy for Acute Ischemic Stroke: The CHOICE-2 Randomized Clinical Trial.

Background

To assess whether adjunctive intra-arterial alteplase after successful thrombectomy improves functional outcomes and cerebral reperfusion.

评估成功血栓切除后辅助动脉内注射阿替普酶是否能改善功能结果和脑部再灌注。

DESIGN, SETTING, AND PARTICIPANTS: Randomized, open-label trial with blinded outcome assessment conducted at 14 stroke centers in Spain from December 11, 2023, through November 26, 2025.

设计、环境和参与者：在2023年12月11日至2025年11月26日期间，于西班牙14个卒中中心进行的随机、开放标签试验，采用盲法评估结果。

A total of 440 patients with acute ischemic stroke due to large vessel occlusion treated with thrombectomy within 24 hours and achieving an expanded Treatment in Cerebral Ischemia score of 2b50 to 3 were randomized.

共有440名因大血管闭塞导致的急性缺血性卒中患者，在24小时内接受血栓切除术治疗，并达到扩展的脑缺血治疗评分2b50至3的患者被随机分配。

Methods

Thrombectomy plus intra-arterial alteplase (0.225 mg/kg; maximum dose, 20 mg) infused over 15 minutes (n = 221) or thrombectomy alone (n = 219).

221名患者接受了血栓切除术联合动脉内注射阿替普酶（0.225 mg/kg；最大剂量20 mg）15分钟输注，或219名患者仅接受血栓切除术。

main_outcomes_and_measures

The primary outcome was an excellent functional outcome at 90 days, which was defined as a modified Rankin Scale score of 0 or 1.

主要结果是90天时的优秀功能结果，定义为改良Rankin量表评分为0或1。

There were 6 secondary outcomes, including residual hypoperfusion on follow-up computed tomography perfusion.

次要结果包括随访计算机断层扫描灌注成像上残余低灌注，共计6项。

The safety outcomes included symptomatic intracranial hemorrhage and death.

安全性结果包括症状性颅内出血和死亡。

Results

Of 3786 patients treated with thrombectomy, 2776 (73%) fulfilled angiographic criteria and 440 (12%) were randomized.

在接受血栓切除术治疗的3786名患者中，有2776名（占73%）符合血管造影标准，另有440名（占12%）被随机分组。

There were 433 patients who were treated as randomized (median age, 76 [IQR, 75-78] years; 51% female).

共有433名患者按照随机分组接受治疗（中位年龄为76岁，四分位数间距为75-78岁；女性占51%）。

At 90 days, 57.5% of patients (123/214) in the thrombectomy plus intra-arterial alteplase group had a modified Rankin Scale score of 0 or 1 vs 42.5% of patients (93/219) in the thrombectomy alone group (adjusted risk difference, 15.0% [95% CI, 5.7% to 24.3%]; P = .002).

在90天时，接受血栓切除术加动脉内注射阿替普酶治疗的患者组中，有57.5%的患者（123/214）的改良Rankin量表评分为0或1，而在仅接受血栓切除术治疗的患者组中，这一比例为42.5%（93/219）（调整后的风险差异为15.0% [95% 置信区间，5.7% 至 24.3%]；P = .002）。

Of 6 secondary outcomes, 4 showed no significant between-group differences.

在6个次要结果指标中，有4个未显示出两组之间的显著差异。

Residual hypoperfusion occurred in 28.6% (55/192) of patients in the thrombectomy plus intra-arterial alteplase group vs 50.5% (96/190) of patients in the thrombectomy alone group (adjusted risk difference, -22.0% [95% CI, -31.5% to -12.4%]; P < .001) and symptomatic intracranial hemorrhage occurred in 1.4% (3/214) vs 0.5% (1/219), respectively (adjusted odds ratio, 3.10 [95% CI, 0.32 to 30.0]; P = .33).

在联合组（28.6%，55/192）和单纯组（50.5%，96/190）中，分别有28.6%和50.5%的患者出现残余低灌注（调整后风险差异，-22.0% [95% 置信区间，-31.5% 至 -12.4%]；P < .001），而症状性颅内出血的发生率分别为1.4%（3/214）和0.5%（1/219）（调整后优势比，3.10 [95% 置信区间，0.32 至 30.0]；P = .33）。

Mortality at 90 days was 12.1% (26/214) in the thrombectomy plus intra-arterial alteplase group vs 6.4% (14/219) in the thrombectomy alone group (adjusted risk difference, 5.9% [95% CI, 0.5% to 11.3%]; P = .03).

90天的死亡率在联合组为12.1%（26/214），而在单纯组为6.4%（14/219）（调整后风险差异，5.9% [95% 置信区间，0.5% 至 11.3%]；P = .03）。

conclusions_and_relevance

Among patients with acute ischemic stroke and successful thrombectomy, adjunctive intra-arterial alteplase increased the proportion achieving excellent functional outcome at 90 days without a significant increase in symptomatic intracranial hemorrhage.

在急性缺血性中风并成功进行血栓切除术的患者中，辅助性动脉内注射阿替普酶增加了90天内达到优秀功能结果的比例，而没有显著增加症状性颅内出血的发生率。

Higher mortality in the thrombectomy plus intra-arterial alteplase group warrants further study.

在血栓切除术加动脉内注射阿替普酶组中，死亡率较高，需要进一步研究。

trial_registration

ClinicalTrials.gov Identifier: NCT05797792.

临床试验注册号：NCT05797792。