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大面积梗死核心患者的血栓切除术:一项采用试验序贯分析的研究水平的荟萃分析。

Thrombectomy for patients with a large infarct core: a study-level meta-analysis with trial sequential analysis.

作者信息

Jhou Hong-Jie, Yang Li-Yu, Chen Po-Huang, Lee Cho-Hao

机构信息

Department of Neurology, Changhua Christian Hospital, Changhua, Taiwan.

School of Medicine, Kaohsiung Medical University, Kaohsiung, Taiwan.

出版信息

Ther Adv Neurol Disord. 2024 Oct 9;17:17562864241285552. doi: 10.1177/17562864241285552. eCollection 2024.

DOI:10.1177/17562864241285552
PMID:39385996
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11462614/
Abstract

BACKGROUND

The effectiveness and safety of endovascular treatment compared with medical management alone regarding outcomes for patients with a large infarct core remain uncertain.

OBJECTIVES

To juxtapose the clinical outcomes of thrombectomy versus the best medical care in patients with a large infarct core.

DESIGN

Systematic review and meta-analysis.

DATA SOURCES AND METHODS

We conducted searches in PubMed, Cochrane, and Embase for articles published up until November 8, 2023. Randomized trials were selected for inclusion if they encompassed patients with large vessel occlusion and sizable strokes receiving thrombectomy. The primary outcome was functional outcomes at 3 months after pooling data using random-effects modeling. Safety outcomes included mortality at 3 months, symptomatic intracranial hemorrhage (SICH), and decompressive craniectomy. We performed a trial sequential analysis to balance type I and II errors.

RESULTS

From 904 citations, we identified six randomized trials, involving a cohort of 1897 patients with a large ischemic region. Of these, 953 individuals underwent endovascular thrombectomy. At 3 months, thrombectomy was significantly correlated with better neurological prognosis, as evidenced by the increased odds of good functional outcomes (odds ratio (OR), 2.90; 95% confidence interval (CI), 2.08-4.05) and favorable functional outcomes (OR, 2.40; 95% CI, 1.86-3.09). Mortality rates did not demonstrably diminish as a consequence of the endovascular management (OR, 0.78; 95% CI, 0.58-1.06). However, the incidence of SICH was greater in the thrombectomy group compared to those with only medical treatment (5.5% vs 3.2%; OR, 1.77; 95% CI, 1.11-2.83). The application of trial sequential analysis yielded definitive evidence regarding favorable function outcomes and a shift in the distribution of modified Rankin scale scores at 3 months; however, others remained inconclusive.

CONCLUSION

The results from most of the included trials display consistency. Meta-analysis of these six randomized trials offers high-quality evidence that thrombectomy significantly mitigates disability in patients with a large infarction, while also increasing the risk of SICH.

TRIAL REGISTRATION

PROSPERO, CRD42023480359.

摘要

背景

对于大面积梗死核心患者,与单纯药物治疗相比,血管内治疗的有效性和安全性在预后方面仍不确定。

目的

比较大面积梗死核心患者血栓切除术与最佳药物治疗的临床结局。

设计

系统评价和荟萃分析。

数据来源和方法

我们在PubMed、Cochrane和Embase中检索截至2023年11月8日发表的文章。如果随机试验纳入了患有大血管闭塞和大面积卒中并接受血栓切除术的患者,则将其纳入。主要结局是在使用随机效应模型汇总数据后3个月时的功能结局。安全性结局包括3个月时的死亡率、症状性颅内出血(SICH)和减压性颅骨切除术。我们进行了试验序贯分析以平衡I型和II型错误。

结果

从904篇文献中,我们确定了6项随机试验,涉及1897例有大面积缺血区域的患者队列。其中,953例患者接受了血管内血栓切除术。在3个月时,血栓切除术与更好的神经学预后显著相关,良好功能结局(优势比(OR),2.90;95%置信区间(CI),2.08 - 4.05)和有利功能结局(OR,2.40;95%CI,1.86 - 3.09)的几率增加证明了这一点。血管内治疗并未明显降低死亡率(OR,0.78;95%CI,0.58 - 1.06)。然而,与仅接受药物治疗的患者相比,血栓切除术组的SICH发生率更高(5.5%对3.2%;OR,1.77;95%CI,1.11 - 2.83)。试验序贯分析的应用产生了关于有利功能结局以及3个月时改良Rankin量表评分分布变化的确切证据;然而,其他方面仍无定论。

结论

大多数纳入试验的结果显示出一致性。对这6项随机试验的荟萃分析提供了高质量证据,表明血栓切除术可显著减轻大面积梗死患者的残疾程度,但同时也增加了SICH的风险。

试验注册

PROSPERO,CRD42023480359。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8e6e/11462614/82df07c1ae10/10.1177_17562864241285552-fig4.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8e6e/11462614/0f2ed10ec0a5/10.1177_17562864241285552-fig1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8e6e/11462614/99946e627f8d/10.1177_17562864241285552-fig2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8e6e/11462614/30ba9cc2eb33/10.1177_17562864241285552-fig3.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8e6e/11462614/82df07c1ae10/10.1177_17562864241285552-fig4.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8e6e/11462614/0f2ed10ec0a5/10.1177_17562864241285552-fig1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8e6e/11462614/99946e627f8d/10.1177_17562864241285552-fig2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8e6e/11462614/30ba9cc2eb33/10.1177_17562864241285552-fig3.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8e6e/11462614/82df07c1ae10/10.1177_17562864241285552-fig4.jpg

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