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在美国人群中使用回归断点分析比较单纯血栓切除术与桥接溶栓治疗。

Comparison of thrombectomy alone versus bridging thrombolysis in a US population using regression discontinuity analysis.

作者信息

Kim Youngran, Salazar-Marioni Sergio, Abdelkhaleq Rania, Iyyangar Ananya, Haussen Diogo, Grossberg Jonathan, Dolia Jaydevsinh, Pabaney Aqueel, Mohammaden Mahmoud, Hassan Ameer, Tekle Wondwossen, Saei Hamzah, Abdalkader Mohamad, Klein Piers, Nisar Taha, Saleemi Adeel, Majidi Shahram, Fifi Johanna, Valestin Gabrielle, Linares Guillermo, Christopher Kara, Liebeskind David S, Jumaa Mouhammad, Zaidi Syed, Nogueira Raul, Mehta Brijesh, Sessa Joy, Vivanco-Suarez Juan, Rodriguez-Calienes Aaron, Galecio-Castillo Milagros, Ortega-Gutierrez Santiago, Siegler James, Penckofer Mary, Linfante Italo, Sheth Sunil A

机构信息

Department of Management, Policy, and Community Health, UTHealth School of Public Health, Houston, TX, USA.

Department of Neurology, UTHealth McGovern Medical School, 6431 Fannin St, MSB 7.220, Houston, TX, 77030, USA.

出版信息

Sci Rep. 2025 May 28;15(1):18757. doi: 10.1038/s41598-025-03249-4.

DOI:10.1038/s41598-025-03249-4
PMID:40436992
原文链接:
https://pmc.ncbi.nlm.nih.gov/articles/PMC12120054/
Abstract

The role of intravenous thrombolysis (IVT) in combination with endovascular thrombectomy (EVT) for the treatment of large vessel occlusion acute ischemic stroke has been evaluated exclusively outside the US, in randomized clinical trials which failed to demonstrate non-inferiority of skipping IVT. Because practice patterns and IVT dosing differ within the US, and prior observational US-based cohorts suggested improved clinical outcomes in patients who received IVT before EVT, a US-based evaluation is needed. This is a quasi-experimental study of a large US cohort using a regression discontinuity design (RDD) that enables the estimation of causal effects when randomization is not feasible. In this multi-center prospective cohort of patients undergoing EVT, we observed a sharp drop (65%) in the probability of receiving IVT at the cutoff of IVT eligibility time window while there were no significant differences in potential confounders including age, NIHSS, and ASPECTS at the cutoff. We found no association between IVT treatment and functional independence (mRS 0-2) at 90-days in patients undergoing EVT, nor in the secondary outcomes of excellent outcomes (mRS 0-1) at 90 days, mortality, symptomatic intracranial hemorrhage, first pass reperfusion, or final reperfusion.

摘要

静脉溶栓(IVT)联合血管内血栓切除术(EVT)治疗大血管闭塞急性缺血性卒中的作用仅在美国以外进行了评估,在随机临床试验中未能证明跳过IVT的非劣效性。由于美国国内的实践模式和IVT剂量不同,且此前基于美国的观察性队列研究表明,在接受EVT前接受IVT的患者临床结局有所改善,因此需要在美国进行评估。这是一项针对美国大型队列的准实验研究,采用回归断点设计(RDD),在无法进行随机化时能够估计因果效应。在这个接受EVT的多中心前瞻性队列中,我们观察到在IVT eligibility时间窗截止点接受IVT的概率急剧下降(65%),而在截止点时包括年龄、美国国立卫生研究院卒中量表(NIHSS)和脑梗死溶栓治疗的脑血流灌注分级(ASPECTS)等潜在混杂因素并无显著差异。我们发现,在接受EVT的患者中,IVT治疗与90天时的功能独立性(改良Rankin量表[mRS] 0 - 2)之间没有关联,在90天时的良好结局(mRS 0 - 1)、死亡率、症状性颅内出血、首次通过再灌注或最终再灌注等次要结局方面也没有关联。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a66c/12120054/9aa1fb7abed3/41598_2025_3249_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a66c/12120054/cd089caeed26/41598_2025_3249_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a66c/12120054/9aa1fb7abed3/41598_2025_3249_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a66c/12120054/cd089caeed26/41598_2025_3249_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a66c/12120054/9aa1fb7abed3/41598_2025_3249_Fig2_HTML.jpg

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本文引用的文献

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JAMA. 2024 Mar 5;331(9):764-777. doi: 10.1001/jama.2024.0589.
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Value of intravenous thrombolysis in endovascular treatment for large-vessel anterior circulation stroke: individual participant data meta-analysis of six randomised trials.静脉溶栓在大血管前循环卒中血管内治疗中的价值:六项随机试验的个体参与者数据荟萃分析
Lancet. 2023 Sep 16;402(10406):965-974. doi: 10.1016/S0140-6736(23)01142-X. Epub 2023 Aug 25.
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Golden Hour Treatment With tPA (Tissue-Type Plasminogen Activator) in the BEST-MSU Study.
BEST-MSU 研究中采用 tPA(组织型纤溶酶原激活剂)进行黄金时段治疗。
Stroke. 2023 Feb;54(2):415-425. doi: 10.1161/STROKEAHA.122.039821. Epub 2023 Jan 23.
4
Endovascular vs Medical Management for Late Anterior Large Vessel Occlusion With Prestroke Disability: Analysis of CLEAR and RESCUE-Japan.血管内治疗与药物治疗对伴有卒中前残疾的急性前循环大血管闭塞的疗效比较:CLEAR 和 RESCUE-Japan 研究分析
Neurology. 2023 Feb 14;100(7):e751-e763. doi: 10.1212/WNL.0000000000201543. Epub 2022 Nov 4.
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Thrombectomy alone versus intravenous alteplase plus thrombectomy in patients with stroke: an open-label, blinded-outcome, randomised non-inferiority trial.单纯取栓与静脉溶栓桥接取栓治疗脑卒中患者的效果比较:一项开放标签、盲法结局、随机非劣效性试验
Lancet. 2022 Jul 9;400(10346):104-115. doi: 10.1016/S0140-6736(22)00537-2.
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