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).

中文翻译：

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急性缺血性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） 的潜在破坏性并发症，但出血程度表明最大的负面影响尚不清楚。我们旨在定义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联。方法 我们对国际加强高血压和溶栓中风研究进行了事后分析。症状性脑出血 （sICH） 是根据既定标准定义的，例如中风监测研究中溶栓的安全实施 （SITS-MOST） 标准。无症状脑出血 （aICH） 定义为任何不符合 sICH 标准的脑出血。使用 Heidelberg 出血分类系统评估出血转化的影像学亚型。主要结局是死亡或严重残疾，定义为 90 天时改良 Rankin 量表 （mRS） 评分 3-6。次要结局包括死亡、死亡或残疾 （mRS 2-6） 和不良健康相关生活质量 （HRQoL），定义为总体健康效用评分 ≤0.7 （平均值）。结果 在 4,370 名参与者中，779 名 （17.8%） 发生颅内出血 （ICH），从随机分组到出血的中位时间为 23.5 小时 （四分位距 18.92-26.07）。根据 SITS-MOST 标准，62 例患者 （占 4,370 例的 1.4%） 被归类为 sICH，717 例患者 （占 4,370 例的 16.4%） 被归类为 aICH。根据 SITS-MOST 标准，sICH 与死亡或严重残疾 （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） 相关。01） 和 HRQoL 差 （OR 17.87,95% CI 7.47-42.71）。同样，根据 SITS-MOST 标准的 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。对于由其他标准定义的 sICH 和 aICH 以及基于海德堡出血分类系统的影像学亚型，观察到类似的关联。讨论急性缺血性卒中中所有形式的 IVT 后出血转化都与不良临床结局的几率增加有关。值得注意的是，IVT 后的 aICH 不应被视为临床无害。试验注册信息 ClinicalTrials.gov （NCT01422616）。