Importance The effectiveness and safety of intravenous alteplase given before or concurrently with endovascular thrombectomy (EVT) is uncertain. Randomized clinical trials suggest there is little difference in outcomes but with only modest precision and insufficient power to analyze uncommon outcomes including symptomatic intracranial hemorrhage (sICH). Objective To determine whether 8 prespecified outcomes are different in patients with acute ischemic stroke treated in routine clinical practice with EVT with alteplase compared with patients treated with EVT alone without alteplase. It was hypothesized that alteplase would be associated with higher risk of sICH. Design, Setting, and Participants This was an observational cohort study conducted from February 1, 2019, to June 30, 2020, that included adult patients with acute ischemic stroke treated with EVT within 6 hours of time last known well, after excluding patients without information on discharge destination and patients with in-hospital stroke. Participants were recruited from Get With The Guidelines-Stroke, a large nationwide registry of patients with acute ischemic stroke from 555 hospitals in the US. Exposures Intravenous alteplase or no alteplase. Main Outcomes and Measures Prespecified outcomes were discharge destination, independent ambulation at discharge, modified Rankin score at discharge, discharge mortality, cerebral reperfusion according to modified Thrombolysis in Cerebral Infarction grade, and sICH. Results There were 15 832 patients treated with EVT (median [IQR] age, 72.0 [61.0-82.0] years; 7932 women [50.1%]); 10 548 (66.7%) received alteplase and 5284 (33.4%) did not. Patients treated with alteplase were younger, arrived via Emergency Medical Services sooner, were less likely to have certain comorbidities, including atrial fibrillation, hypertension, and diabetes, but had similar National Institutes of Health Stroke Severity (NIHSS) scores. Compared with patients who did not receive alteplase treatment, patients treated with alteplase were less likely to die (11.1% [1173 of 10 548 patients] vs 13.9% [734 of 5284 patients]; adjusted odds ratio [aOR] 0.83; 95% CI, 0.77-0.89; P < .001), more likely to have no major disability based on modified Rankin scale of 2 or less at discharge (28.5% [2415 of 8490 patients] vs 20.7% [894 of 4322 patients]; aOR, 1.36; 95% CI, 1.28-1.45; P < .001), and to have better reperfusion based on modified Thrombolysis in Cerebral Infarction grade 2b or greater (90.9% [8474 of 9318 patients] vs 88.0% [4140 of 4705 patients]; aOR, 1.39; 95% CI, 1.28-1.50; P < .001). However, alteplase treatment was associated with higher risk of sICH (6.5% [685 of 10 530 patients] vs 5.3% [279 of 5249 patients]; OR, 1.28; 95% CI, 1.16-1.42; P < .001). Conclusions and Relevance In this observational cohort study of patients treated with EVT, intravenous alteplase treatment was associated with better in-hospital survival and functional outcomes but higher sICH risk after adjusting for other covariates.

中文翻译：

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常规临床实践中使用或不使用阿替普酶的血管内血栓切除术后的结果。

重要性 在血管内血栓切除术 (EVT) 之前或同时给予静脉内阿替普酶的有效性和安全性尚不确定。随机临床试验表明结果几乎没有差异，但只有适度的精度和不足以分析不常见的结果，包括症状性颅内出血 (sICH)。目的 确定在常规临床实践中接受 EVT 联合阿替普酶治疗的急性缺血性卒中患者与仅接受 EVT 联合阿替普酶治疗的患者相比，8 个预设结局是否不同。据推测，阿替普酶与更高的 sICH 风险相关。设计、设置和参与者 这是一项观察性队列研究，时间为 2019 年 2 月 1 日至 2020 年 6 月 30 日，其中包括在最后一次已知时间 6 小时内接受 EVT 治疗的急性缺血性卒中成年患者，排除了没有出院目的地信息的患者和院内卒中患者。参与者是从 Get With The Guidelines-Stroke 招募的，该指南是一项针对美国 555 家医院的急性缺血性卒中患者的大型全国性登记。暴露 静脉内阿替普酶或无阿替普酶。主要结局和测量指标预设结局为出院目的地、出院时独立行走、出院时改良 Rankin 评分、出院死亡率、根据改良脑梗死溶栓分级的脑再灌注和 sICH。结果 15832 名接受 EVT 治疗的患者（中位 [IQR] 年龄，72.0 [61.0-82.0] 岁；7932 名女性 [50.1%]）；10 548 (66. 7% 接受阿替普酶治疗，5284 人 (33.4%) 未接受阿替普酶治疗。接受阿替普酶治疗的患者更年轻，通过紧急医疗服务到达的时间更早，患房颤、高血压和糖尿病等某些合并症的可能性更小，但美国国立卫生研究院卒中严重程度 (NIHSS) 评分相似。与未接受阿替普酶治疗的患者相比，接受阿替普酶治疗的患者死亡的可能性较小（11.1% [10548 名患者中的 1173 名] vs 13.9% [5284 名患者中的 734 名]；调整后的比值比 [aOR] 0.83；95% CI , 0.77-0.89；P < .001），出院时根据改良 Rankin 量表评分为 2 或更低的人更有可能没有重大残疾（28.5% [8490 名患者中的 2415 名] vs 20.7% [4322 名患者中的 894 名]；aOR， 1.36；95% CI，1.28-1.45；P < .001）并且根据脑梗塞改良溶栓治疗 2b 级或更高级别获得更好的再灌注（90.9% [9318 名患者中的 8474 名] vs 88.0% [4705 名患者中的 4140 名]；aOR，1.39；95% CI，1.28-1.50；P < . 001). 然而，阿替普酶治疗与更高的 sICH 风险相关（6.5% [10530 名患者中的 685 名] vs 5.3% [5249 名患者中的 279 名]；OR，1.28；95% CI，1.16-1.42；P < .001）。结论和相关性 在这项针对接受 EVT 治疗的患者的观察性队列研究中，静脉内阿替普酶治疗与更好的院内生存和功能结果相关，但在调整其他协变量后与更高的 sICH 风险相关。5% [10530 名患者中的 685 名] vs 5.3% [5249 名患者中的 279 名]；或者，1.28；95% 置信区间，1.16-1.42；P <.001）。结论和相关性 在这项针对接受 EVT 治疗的患者的观察性队列研究中，静脉内阿替普酶治疗与更好的院内生存和功能结果相关，但在调整其他协变量后与更高的 sICH 风险相关。5% [10530 名患者中的 685 名] vs 5.3% [5249 名患者中的 279 名]；或者，1.28；95% 置信区间，1.16-1.42；P <.001）。结论和相关性 在这项针对接受 EVT 治疗的患者的观察性队列研究中，静脉内阿替普酶治疗与更好的院内生存和功能结果相关，但在调整其他协变量后与更高的 sICH 风险相关。