Patterns and Clinical Implications of Hemorrhagic Transformation After Thrombolysis in Acute Ischemic Stroke: Results From the ENCHANTED Study.

IF 7.7 1区医学 Q1 CLINICAL NEUROLOGY Neurology Pub Date : 2024-12-10 Epub Date: 2024-11-14 DOI:10.1212/WNL.0000000000210020

Yanan Wang, Toshiki Maeda, Shoujiang You, Chen Chen, Leibo Liu, Zien Zhou, Thompson G Robinson, Richard Iain Lindley, Candice Delcourt, Grant Mair, Joanna M Wardlaw, John Philip Chalmers, Hisatomi Arima, Yining Huang, Jong S Kim, Pablo M Lavados, Tsong-Hai Lee, Christopher Levi, Mark W Parsons, Sheila Co Martins, Jeyaraj Durai Pandian, Octavio M Pontes-Neto, Vijay K Sharma, Thang Huy Nguyen, Jiguang Wang, Simiao Wu, Ming Liu, Craig S Anderson, Xiaoying Chen

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Abstract

Background and objectives: Hemorrhagic transformation may be a potentially devastating complication of IV thrombolysis (IVT) in acute ischemic stroke, but what degree of hemorrhage indicates the greatest negative effect is not known. We aimed to define the associations between hemorrhagic transformation patterns, classified according to clinical and imaging categories, and clinical outcomes after IVT.

Methods: We conducted a post hoc analysis from the international Enhanced Control of Hypertension and Thrombolysis Stroke Study. Symptomatic intracerebral hemorrhage (sICH) was defined based on established criteria, such as the Safe Implementation of Thrombolysis in Stroke-Monitoring Study (SITS-MOST) criteria. Asymptomatic intracerebral hemorrhage (aICH) was defined as any intracerebral hemorrhage that did not meet the criteria for sICH. Imaging subtypes of hemorrhagic transformation were assessed using the Heidelberg Bleeding Classification system. The primary outcome was death or major disability, defined by modified Rankin scale (mRS) scores 3-6 at 90 days. Secondary outcomes included death, death or disability (mRS 2-6), and poor health-related quality of life (HRQoL), defined as an overall heath utility score ≤0.7 (mean).

Results: Of the 4,370 participants, 779 (17.8%) developed any intracranial hemorrhage (ICH), with a median time from randomization to hemorrhage of 23.5 hours (interquartile range 18.92-26.07). According to the SITS-MOST criteria, 62 patients (1.4% of 4,370) were classified as sICH, and 717 patients (16.4% of 4,370) were classified as aICH. sICH per SITS-MOST criteria was associated with death or major disability (odds ratio [OR] 23.05, 95% CI 8.97-59.23), death (OR 20.14, 95% CI 11.32-35.84), death or disability (OR 61.36, 95% CI 8.40-448.01), and poor HRQoL (OR 17.87, 95% CI 7.47-42.71). Similarly, aICH per SITS-MOST criteria was also associated with death or major disability (OR 2.23, 95% CI 1.84-2.70), death (OR 1.82, 95% CI 1.39-2.38), death or disability (OR 2.29, 95% CI 1.87-2.80), and poor HRQoL (OR 1.81, 95% CI 1.50-2.18). Comparable associations were observed for sICH and aICH defined by other criteria, as well as for imaging subtypes based on Heidelberg Bleeding Classification system.

Discussion: All forms of post-IVT hemorrhagic transformation in acute ischemic stroke are associated with increased odds of poor clinical outcomes. Of note, aICH after IVT should not be considered clinically innocuous.

Trial registration information: ClinicalTrials.gov (NCT01422616).

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急性缺血性脑卒中溶栓后出血转化的模式和临床意义：ENCHANTED研究的结果

背景和目的：出血转化可能是急性缺血性卒中静脉溶栓（IVT）的一种潜在破坏性并发症，但何种程度的出血会产生最大的负面影响尚不清楚。我们旨在明确根据临床和影像学分类的出血转化模式与 IVT 后临床结局之间的关系：我们对国际高血压强化控制和溶栓卒中研究进行了事后分析。无症状性脑出血（sICH）的定义基于既定标准，如脑卒中溶栓治疗安全实施监测研究（SITS-MOST）标准。无症状性脑出血（aICH）是指不符合sICH标准的任何脑出血。出血性转化的影像学亚型采用海德堡出血分类系统进行评估。90天后的主要结果是死亡或严重残疾，定义为改良Rankin量表（mRS）3-6分。次要结果包括死亡、死亡或残疾（mRS 2-6）以及健康相关生活质量（HRQoL）低下，定义为总体健康效用评分≤0.7（平均值）：在4370名参与者中，有779人（17.8%）发生了颅内出血（ICH），从随机化到出血的中位时间为23.5小时（四分位距为18.92-26.07）。根据SITS-MOST标准，62名患者（4370人中的1.4%）被归类为sICH，717名患者（4370人中的16.4%）被归类为aICH。根据SITS-MOST标准，sICH与死亡或严重残疾相关（比值比 [OR] 23.05，95% CI 8.97-59.23）、死亡（OR 20.14，95% CI 11.32-35.84）、死亡或残疾（OR 61.36，95% CI 8.40-448.01）和 HRQoL 差（OR 17.87，95% CI 7.47-42.71）相关。同样，根据 SITS-MOST 标准，aICH 也与死亡或严重残疾（OR 2.23，95% CI 1.84-2.70）、死亡（OR 1.82，95% CI 1.39-2.38）、死亡或残疾（OR 2.29，95% CI 1.87-2.80）和 HRQoL 差（OR 1.81，95% CI 1.50-2.18）相关。根据其他标准定义的sICH和aICH，以及基于海德堡出血分类系统的影像学亚型，也观察到了类似的关联：讨论：急性缺血性卒中 IVT 后各种形式的出血转化均与不良临床预后几率增加有关。值得注意的是，IVT 后的 aICH 在临床上不应被视为无害：试验注册信息：ClinicalTrials.gov (NCT01422616)。

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来源期刊

Neurology 医学-临床神经学

CiteScore

12.20

自引率

4.00%

发文量

1973

审稿时长

2-3 weeks

期刊介绍： Neurology, the official journal of the American Academy of Neurology, aspires to be the premier peer-reviewed journal for clinical neurology research. Its mission is to publish exceptional peer-reviewed original research articles, editorials, and reviews to improve patient care, education, clinical research, and professionalism in neurology. As the leading clinical neurology journal worldwide, Neurology targets physicians specializing in nervous system diseases and conditions. It aims to advance the field by presenting new basic and clinical research that influences neurological practice. The journal is a leading source of cutting-edge, peer-reviewed information for the neurology community worldwide. Editorial content includes Research, Clinical/Scientific Notes, Views, Historical Neurology, NeuroImages, Humanities, Letters, and position papers from the American Academy of Neurology. The online version is considered the definitive version, encompassing all available content. Neurology is indexed in prestigious databases such as MEDLINE/PubMed, Embase, Scopus, Biological Abstracts®, PsycINFO®, Current Contents®, Web of Science®, CrossRef, and Google Scholar.