Intracranial Hemorrhage in Patients With Stroke After Endovascular Treatment With or Without IV Alteplase: An Individual Participant Data Meta-Analysis.

Background

To determine the frequency and subtypes of ICH in patients treated with IVT plus EVT vs EVT alone and to determine the association between various ICH subtypes and patient functional outcomes.

确定接受IVT加EVT治疗与仅接受EVT治疗的患者中ICH的频率和亚型，并确定各种ICH亚型与患者功能结果之间的关联。

data_sources

PubMed and MEDLINE were searched from database inception through March 9, 2023.

从数据库创建之初至2023年3月9日，对PubMed和MEDLINE进行了检索。

study_selection

Randomized clinical trials comparing EVT alone with IVT plus EVT for anterior circulation large vessel occlusion stroke were included.

纳入了比较仅机械取栓(EVT)与静脉溶栓(IVT)联合机械取栓治疗前循环大血管闭塞性中风的随机临床试验。

data_extraction_and_synthesis

Individual participant data were extracted following the Preferred Reporting Items for Systematic Reviewand Meta-Analyses of independent participant data (PRISMA-IPD) reporting guidelines.

根据独立参与者数据的系统评价和荟萃分析首选报告项目（PRISMA-IPD）报告指南，提取了个体参与者数据。

Data were pooled using a random-effects model.

使用随机效应模型汇总了数据。

Data were analyzed between April 2024 and February 2025.

数据分析时间为2024年4月至2025年2月。

main_outcomes_and_measures

The primary outcomes were ICH and its subtypes according to the Heidelberg Bleeding Classification (hemorrhagic infarction type 1 [HI1], hemorrhagic infarction type 2 [HI2], parenchymal hematoma type 1 [PH1], parenchymal hematoma type 2 [PH2], and others; symptomatic or asymptomatic ICH), which were evaluated using a mixed-model approach with multinomial or binary regression.

主要结果是根据海德堡出血分类法的ICH及其亚型（出血性梗死1型[HI1]、出血性梗死2型[HI2]、实质内血肿1型[PH1]、实质内血肿2型[PH2]及其他；有症状或无症状的ICH），采用混合模型方法结合多项式或二元回归进行评估。

Results

The analysis involved 2313 participants (1160 allocated to the IVT plus EVT group vs 1153 to EVT alone; median [IQR] age, 71 [62-78] years; 1025 female participants [44%]) from 6 studies.

分析涉及来自6项研究的2313名参与者（1160名被分配到IVT加EVT组与1153名仅接受EVT治疗；中位年龄[四分位数间距]为71[62-78]岁；1025名女性参与者[占44%]）

Any ICH occurred in 768 of 2261 participants (34%).

在2261名参与者中，有768人发生了任何一种ICH（占34%）。

IVT was associated with an increased rate of any ICH (411 of 1133 [36%] vs 357 of 1128 [32%]; adjusted odds ratio [OR], 1.23; 95% CI, 1.02-1.49; P = .03) and a higher rate of any parenchymal hematoma (PH1 or PH2) (82 of 1133 [7%] vs 61 of 1128 [5%]; adjusted OR, 1.54; 95% CI, 1.02-2.34; P = .04).

静脉溶栓治疗（IVT）与任何颅内出血（ICH）的发生率增加有关（1133名患者中有411例[36%]对比1128名患者中有357例[32%]；调整后的比值比[OR]为1.23；95%置信区间为1.02-1.49；P = .03），以及任何脑实质血肿（PH1或PH2）的发生率更高（1133名患者中有82例[7%]对比1128名患者中有61例[5%]；调整后的比值比为1.54；95%置信区间为1.02-2.34；P = .04）。

Compared with participants without ICH, asymptomatic ICH (adjusted common OR, 0.55; 95% CI, 0.46-0.65) and symptomatic ICH (adjusted common OR, 0.08; 95% CI, 0.05-0.13) were both associated with worse functional outcomes, and there was a graded association of ICH radiologic patterns and patient outcomes.

与没有颅内出血（ICH）的参与者相比，无症状ICH（调整后的共同比值比为0.55；95%置信区间为0.46-0.65）和有症状ICH（调整后的共同比值比为0.08；95%置信区间为0.05-0.13）都与较差的功能预后相关，且ICH的放射学模式与患者预后之间存在分级关联。

conclusions_and_relevance

In this individual participant data meta-analysis, compared with EVT alone, IVT plus EVT modestly increased the risk of ICH, notably any parenchymal hematoma.

在这项个体患者数据的荟萃分析中，与单独的EVT相比，IVT加EVT轻微增加了ICH的风险，特别是任何脑实质血肿。

Although ICH was associated with worse functional outcomes, this effect may be offset by IVT's benefit in final successful reperfusion and early reperfusion.

尽管ICH与较差的功能结果相关，但IVT在最终成功再通和早期再通方面的益处可能会抵消这种影响。