Intra-Arterial Alteplase After Successful Endovascular Reperfusion in Acute Stroke

医学 溶栓 改良兰金量表 随机对照试验 冲程(发动机) 闭塞 心脏病学 急性中风 血管内治疗 脑梗塞 外科 内科学 临床试验 再灌注治疗 脑出血 纤溶剂 麻醉 心肌梗塞 随机化 梗塞 组织纤溶酶原激活剂
作者
Aoming Jin,Bing Sun,Chengbo Dai,Hongbing Chen,Hongyu Qiao,Jinsong You,Kangning Chen,Shuo Wang,Weihua Deng,Xu Tong,Yueqi Zhu,Zhong Ji,Xinguang Yang,Xiongjun He,Yongteng Xu,Dong Pan,Kaifeng Li,Yanting Chen,Yingying Zhu,Yuesong Pan
出处
期刊:JAMA [American Medical Association]
卷期号:334 (19): 1728-1728 被引量:9
标识
DOI:10.1001/jama.2025.16876
摘要

Importance Functional outcomes in patients with acute ischemic stroke due to large-vessel occlusion who undergo thrombectomy remain suboptimal, and the benefits of intra-arterial alteplase after thrombectomy remain uncertain. Objective To investigate whether treatment with intra-arterial alteplase after successful endovascular reperfusion improves functional outcomes among patients with acute, anterior-circulation, large-vessel occlusion stroke. Design, Setting, and Participants This multicenter, randomized clinical trial recruited patients with anterior-circulation, large-vessel occlusion stroke within 24 hours of symptom onset who achieved successful reperfusion (expanded Thrombolysis in Cerebral Infarction scale score of ≥2b50) after thrombectomy. Guideline-based intravenous thrombolysis was allowed. Patients were randomized between August 1, 2023, and October 16, 2024, and the trial was conducted at 28 hospitals in China. Final follow-up occurred on January 7, 2025. Interventions Intra-arterial alteplase treatment (n = 164) with 0.225 mg/kg (maximum dose of 20 mg) vs standard treatment (n = 160). Main Outcomes and Measures The primary outcome was the proportion of patients with a modified Rankin Scale score of 0 or 1 at 90 days (score range, 0 [no symptoms] to 6 [death]; a score of 0 or 1 indicates an excellent outcome). The safety outcomes included symptomatic intracranial hemorrhage within 36 hours of randomization, all-cause mortality within 90 days, and any intracranial hemorrhage within 36 hours. Results Of the 324 patients randomized (median age, 68 years [IQR, 58-75 years]; 99 were female [30.6%]), 1 patient in each group was lost to follow-up. The proportion of patients with a modified Rankin Scale score of 0 or 1 at 90 days was 44.8% (73/163) in the intra-arterial alteplase group vs 30.2% (48/159) in the standard treatment group (adjusted risk ratio [RR], 1.45 [95% CI, 1.08-1.96]; P = .01). The proportion of patients with symptomatic intracranial hemorrhage within 36 hours was 4.3% (7/164) in the intra-arterial alteplase group vs 5.0% (8/160) in the standard treatment group (adjusted RR, 0.85 [95% CI, 0.43-1.69]; P = .67). The proportion of patients with all-cause mortality within 90 days was 17.1% (28/164) in the intra-arterial alteplase group vs 11.3% (18/160) in the standard treatment group (adjusted hazard ratio, 1.60 [95% CI, 0.88-2.89]; P = .12). The proportion of patients with any intracranial hemorrhage within 36 hours was 32.9% (54/164) in the intra-arterial alteplase group vs 26.9% (43/160) in the standard treatment group (adjusted RR, 1.22 [95% CI, 0.92-1.63]; P = .17). Conclusions and Relevance Among patients with acute, anterior-circulation, large-vessel occlusion stroke who achieved successful endovascular reperfusion by mechanical thrombectomy, intra-arterial alteplase resulted in a higher likelihood of excellent outcomes at 90 days. The incidence of all-cause mortality and any intracranial hemorrhage was higher in patients who received intra-arterial alteplase, although these differences were not statistically significant. Trial Registration ClinicalTrials.gov Identifier: NCT05856851
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