Background Stereotactic thrombolysis reduces intracerebral haemorrhage (ICH) volume in patients with spontaneous ICH. Whether intrahaematomal alteplase administration is associated with a change in intraventricular haemorrhage volume (deltaIVH) and functional outcomes is unknown. Methods Post hoc secondary analysis of the Minimally Invasive Surgery plus Alteplase for Intracerebral Hemorrhage Evacuation Phase III (MISTIE-III) trial in patients with IVH on the stability CT scan. Exposure was minimally invasive surgery plus alteplase (MIS+alteplase). Primary outcome was deltaIVH defined as IVH volume on end-of-treatment CT minus IVH volume on stability CT scan. Secondary outcomes were favourable functional outcome (modified Rankin Scale 0–3) and mortality at 365 days. We assessed the relationship between MIS+alteplase and deltaIVH in the primary analysis using multivariable linear regression, and between deltaIVH and functional outcomes in secondary analyses using multiple logistic regression. Results Of 499 patients in MISTIE-III, 310 (62.1%) had IVH on stability scans; mean age (SD) was 61.2±12.3 years. A total of 146 (47.1%) received the MISTIE procedure and 164 (52.9%) standard medical care (SMC) only. The MIS+alteplase group had a greater mean reduction in IVH volume compared with the SMC group (deltaIVH: −2.35 (5.30) mL vs −1.15 (2.96) mL, p=0.02). While IVH volume decreased significantly in both treatment groups, in the primary analysis, MIS+alteplase was associated with greater deltaIVH in multivariable linear regression analysis adjusted for potential confounders (β −0.80; 95% CI −1.37 to −0.22, p=0.007). Secondary analysis demonstrated no associations between IVH reduction and functional outcomes (adjusted OR (aOR) for poor outcome 1.02; 95% CI 0.96 to 1.08, p=0.61; aOR for mortality 0.99; 95% CI 0.92 to 1.06, p=0.77). Conclusions Alteplase delivered into the ICH in MISTIE-III subjects with IVH was associated with a small reduction in IVH volume. This reduction did not translate into a significant benefit in mortality or functional outcomes at 365 days. Trial registration number [NCT01827046][1]. Data are available upon reasonable request. Interested researchers may formally request access to the dataset by submitting a proposal. [1]: /lookup/external-ref?link_type=CLINTRIALGOV&access_num=NCT01827046&atom=%2Fjnnp%2Fearly%2F2024%2F04%2F25%2Fjnnp-2023-333032.atom

中文翻译：

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阿替普酶立体定向溶栓治疗脑出血是否会改变脑室内血肿体积？ MISTIE-III 试验的二次分析

背景 立体定向溶栓可减少自发性 ICH 患者的脑出血 (ICH) 量。血肿内阿替普酶给药是否与脑室内出血量 (deltaIVH) 和功能结果的变化相关尚不清楚。方法 对稳定性 CT 扫描中 IVH 患者的微创手术加阿替普酶治疗脑出血清除 III 期 (MISTIE-III) 试验进行事后二次分析。暴露方式为微创手术加阿替普酶（MIS+阿替普酶）。主要结果是 deltaIVH，定义为治疗结束时 CT 上的 IVH 体积减去稳定性 CT 扫描上的 IVH 体积。次要结局是良好的功能结局（改良Rankin量表0-3）和365天死亡率。我们在主要分析中使用多变量线性回归评估了 MIS+阿替普酶与 deltaIVH 之间的关系，在二次分析中使用多元逻辑回归评估了 deltaIVH 与功能结果之间的关系。结果 MISTIE-III 中的 499 名患者中，310 名（62.1%）在稳定性扫描中出现 IVH；平均年龄（SD）为 61.2±12.3 岁。共有 146 人（47.1%）接受了 MISTIE 手术，164 人（52.9%）仅接受了标准医疗护理 (SMC)。与 SMC 组相比，MIS+阿替普酶组的 IVH 体积平均减少幅度更大（deltaIVH：-2.35 (5.30) mL vs -1.15 (2.96) mL，p=0.02）。虽然两个治疗组的 IVH 体积均显着减少，但在初步分析中，在针对潜在混杂因素进行调整的多变量线性回归分析中，MIS+阿替普酶与更大的 deltaIVH 相关（β -0.80；95% CI -1.37 至 -0.22，p=0.007） 。二次分析表明 IVH 减少和功能结果之间没有关联（不良结果的调整 OR (aOR) 1.02；95% CI 0.96 至 1.08，p=0.61；死亡率 aOR 0.99；95% CI 0.92 至 1.06，p=0.77）。结论 在患有 IVH 的 MISTIE-III 受试者中，将阿替普酶递送至 ICH 与 IVH 体积小幅减少相关。这种减少并没有转化为 365 天死亡率或功能结果的显着改善。试用注册号[NCT01827046][1]。数据可根据合理要求提供。感兴趣的研究人员可以通过提交提案正式请求访问数据集。 [1]: /lookup/external-ref?link_type=CLINTRIALGOV&access_num=NCT01827046&atom=%2Fjnnp%2Fearly%2F2024%2F04%2F25%2Fjnnp-2023-333032.atom