The George Institute for Global Health, Beijing, China.
Department of Neurology, Division of Neurocritical Care, Johns Hopkins Medical Institutions, Baltimore, Maryland, USA.
Stroke Vasc Neurol. 2024 Aug 27;9(4):446-456. doi: 10.1136/svn-2023-002463.
Minimally invasive surgery (MIS) for spontaneous supratentorial intracerebral haemorrhage (ICH) is controversial but may be beneficial if end-of-treatment (EOT) haematoma volume is reduced to ≤15 mL. We explored whether MRI findings of cerebral small vessel disease (CSVD) modify the effect of MIS on long-term outcomes.
Prespecified blinded subgroup analysis of 288 subjects with qualified imaging sequences from the phase 3 Minimally Invasive Surgery Plus Alteplase for Intracerebral Haemorrhage Evacuation (MISTIE) trial. We tested for heterogeneity in the effects of MIS and MIS+EOT volume ≤15 mL on the trial's primary outcome of good versus poor function at 1 year by the presence of single CSVD features and CSVD scores using multivariable models.
Of 499 patients enrolled in MISTIE III, 288 patients had MRI, 149 (51.7%) randomised to MIS and 139 (48.3%) to standard medical care (SMC). Median (IQR) ICH volume was 42 (30-53) mL. In the full MRI cohort, there was no statistically significant heterogeneity in the effects of MIS versus SMC on 1-year outcomes by any specific CSVD feature or by CSVD scores (all P >0.05). In 94 MIS patients with EOT ICH volume ≤15 mL, significant reduction in odds of poor outcome was found with cerebral amyloid angiopathy score <2 (OR, 0.14 (0.05-0.42); P=0.006), absence of lacunes (OR, 0.37 (0.18-0.80); P=0.02) and absence of severe white matter hyperintensities (WMHs) (OR, 0.22 (0.08-0.58); P=0.03).
Following successful haematoma reduction by MIS, we found significantly lower odds of poor functional outcome with lower total burden of CSVD in addition to absence of lacunes and severe WMHs. CSVD features may have utility for prognostication and patient selection in clinical trials of MIS.
微创外科手术（MIS）治疗自发性幕上脑出血（ICH）存在争议，但如果治疗结束时（EOT）血肿体积减少至≤15mL，则可能有益。我们探讨了脑小血管病（CSVD）的 MRI 表现是否改变 MIS 对长期结果的影响。
对 3 期微创外科手术加阿替普酶治疗脑出血清除术（MISTIE）试验中具有合格影像学序列的 288 名受试者进行预设的盲法亚组分析。我们使用多变量模型，通过单一 CSVD 特征和 CSVD 评分，测试 MIS 和 EOT 体积≤15mL 对试验主要结局（1 年时功能良好与不良）的影响是否存在异质性。
在 MISTIE III 中，499 名患者入组，288 名患者接受 MRI，149 名（51.7%）随机分配至 MIS 组，139 名（48.3%）分配至标准药物治疗（SMC）组。ICH 体积中位数（IQR）为 42（30-53）mL。在完整 MRI 队列中，通过任何特定 CSVD 特征或 CSVD 评分，MIS 与 SMC 对 1 年结局的影响均无统计学显著异质性（所有 P>0.05）。在 94 名 EOT ICH 体积≤15mL 的 MIS 患者中，发现大脑淀粉样血管病评分<2（OR，0.14（0.05-0.42）；P=0.006）、无腔隙（OR，0.37（0.18-0.80）；P=0.02）和无严重白质高信号（WMHs）（OR，0.22（0.08-0.58）；P=0.03）显著降低不良结局的可能性。
在血肿成功减少后，我们发现除了腔隙和严重 WMHs 外，CSVD 总负担较低与 MIS 后较差的功能结局可能性降低显著相关。CSVD 特征可能对 MIS 临床试验的预后和患者选择具有实用性。
