Chun-Hsien Lin, Meng Lee, Bruce Ovbiagele, David S Liebeskind, Borja Sanz-Cuesta, Jeffrey L Saver
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Randomized controlled trials (RCTs) of patients with acute stroke and a large ischemic core that compared EVT plus medical care versus medical care alone were evaluated. We computed the random-effects estimate based on the inverse variance method. Risk ratio (RR) with 95% confidence interval (CI) was used to measure outcomes of EVT plus medical care versus medical care alone. The primary outcome was functional independence, defined as modified Rankin Scale (mRS) of 0-2 at 90 days post-stroke; and the lead secondary outcome was reduced disability, defined as ordinal shift of mRS. Safety outcomes were requiring constant care or death (mRS 5-6), death, and early symptomatic intracranial hemorrhage (sICH). Grading of Recommendations Assessment, Development and Evaluations (GRADE) was used to evaluate summaries of evidence for the outcomes. We included six RCTs comprising 1870 patients (826 females [44.2%]) with acute stroke and a larger moderate or large ischemic core due to ICA or MCA M1 occlusion. All patients were nondisabled before stroke. Pooled results showed that at 90 days post-stroke, EVT plus medical care, compared with medical care alone, was associated with greater functional independence (RR 2.53, 95% CI [1.95, 3.29]; p < 0.001; number needed to treat [NNT], 9, 95% CI [6,15]) and reduced disability (common odds ratio 1.63, 95% CI [1.38, 1.93]; p < 0.001; NNT, 4 [minimum possible NNT, 2; maximum possible NNT, 6]). EVT plus medical care, compared with medical care alone, was associated with a lower risk of requiring constant care or death (RR 0.74, 95% CI [0.66, 0.84]; p < 0.001; NNT, 7, 95% CI [6,11]). EVT plus medical care, compared with medical care alone, was associated with a nonsignificantly higher proportion of patients with early symptomatic intracranial hemorrhage (RR 1.65, 95% CI [1.00, 2.70]; p = 0.05). The rates of death were not significantly different between the EVT plus medical care and medical care alone groups (RR 0.86, 95% CI [0.72, 1.02]; p = 0.08). Main limitations include variability in imaging definitions of large core and inclusion of both larger moderate and large cores in the analysis.</p><p><strong>Conclusions: </strong>Among patients with acute stroke and a larger moderate or large ischemic core due to ICA or MCA M1 occlusion who were nondisabled before stroke, EVT plus medical care, compared with medical care alone, may be associated with improved functional independence, reduced disability, and reduced rates of severe disability or death at 90 days post-stroke. PROSPERO registration number: CRD42024514605.</p>","PeriodicalId":49008,"journal":{"name":"PLoS Medicine","volume":"22 4","pages":"e1004484"},"PeriodicalIF":15.8000,"publicationDate":"2025-04-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12037071/pdf/","citationCount":"0","resultStr":"{\"title\":\"Endovascular thrombectomy in acute stroke with a large ischemic core: A systematic review and meta-analysis of randomized controlled trials.\",\"authors\":\"Chun-Hsien Lin, Meng Lee, Bruce Ovbiagele, David S Liebeskind, Borja Sanz-Cuesta, Jeffrey L Saver\",\"doi\":\"10.1371/journal.pmed.1004484\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>Endovascular thrombectomy (EVT) is the standard treatment for acute ischemic stroke due to internal carotid artery (ICA) or middle cerebral artery (MCA) M1 occlusion with a small ischemic core. However, the effect of EVT on acute stroke with a large ischemic core remains unclear. This study aimed to evaluate the association of EVT plus medical care versus medical care alone with outcomes in patients with acute stroke and a large ischemic core due to ICA or MCA M1 occlusion.</p><p><strong>Methods and findings: </strong>PubMed, the Cochrane Central Register of Controlled Trials, and ClinicalTrials.gov were searched from January 1, 2000 to September 25, 2024. There were no language restrictions. Randomized controlled trials (RCTs) of patients with acute stroke and a large ischemic core that compared EVT plus medical care versus medical care alone were evaluated. We computed the random-effects estimate based on the inverse variance method. Risk ratio (RR) with 95% confidence interval (CI) was used to measure outcomes of EVT plus medical care versus medical care alone. The primary outcome was functional independence, defined as modified Rankin Scale (mRS) of 0-2 at 90 days post-stroke; and the lead secondary outcome was reduced disability, defined as ordinal shift of mRS. Safety outcomes were requiring constant care or death (mRS 5-6), death, and early symptomatic intracranial hemorrhage (sICH). Grading of Recommendations Assessment, Development and Evaluations (GRADE) was used to evaluate summaries of evidence for the outcomes. We included six RCTs comprising 1870 patients (826 females [44.2%]) with acute stroke and a larger moderate or large ischemic core due to ICA or MCA M1 occlusion. All patients were nondisabled before stroke. Pooled results showed that at 90 days post-stroke, EVT plus medical care, compared with medical care alone, was associated with greater functional independence (RR 2.53, 95% CI [1.95, 3.29]; p < 0.001; number needed to treat [NNT], 9, 95% CI [6,15]) and reduced disability (common odds ratio 1.63, 95% CI [1.38, 1.93]; p < 0.001; NNT, 4 [minimum possible NNT, 2; maximum possible NNT, 6]). EVT plus medical care, compared with medical care alone, was associated with a lower risk of requiring constant care or death (RR 0.74, 95% CI [0.66, 0.84]; p < 0.001; NNT, 7, 95% CI [6,11]). EVT plus medical care, compared with medical care alone, was associated with a nonsignificantly higher proportion of patients with early symptomatic intracranial hemorrhage (RR 1.65, 95% CI [1.00, 2.70]; p = 0.05). The rates of death were not significantly different between the EVT plus medical care and medical care alone groups (RR 0.86, 95% CI [0.72, 1.02]; p = 0.08). 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引用次数: 0
摘要
背景:血管内取栓术(EVT)是治疗因颈动脉(ICA)或大脑中动脉(MCA) M1闭塞而伴有小缺血性核心的急性缺血性卒中的标准治疗方法。然而,EVT对急性缺血性脑卒中的影响尚不清楚。本研究旨在评估EVT加医疗护理与单独医疗护理与急性卒中患者因ICA或MCA M1闭塞导致的大缺血核心预后的关系。方法和发现:检索2000年1月1日至2024年9月25日期间的PubMed、Cochrane中央对照试验注册库和ClinicalTrials.gov。没有语言限制。随机对照试验(rct)比较EVT加医疗护理与单独医疗护理的急性卒中和大缺血核心患者。我们计算了基于逆方差法的随机效应估计。采用95%可信区间(CI)的风险比(RR)来衡量EVT加医疗护理与单独医疗护理的结果。主要终点是功能独立性,定义为卒中后90天的修正Rankin量表(mRS) 0-2;主要次要结局是残疾减少,定义为mRS的顺序转移。安全结局是需要持续护理或死亡(mRS 5-6)、死亡和早期症状性颅内出血(sICH)。建议分级评估、发展和评价(GRADE)用于评价结果的证据摘要。我们纳入了6项随机对照试验,包括1870例急性卒中患者(826例女性[44.2%]),由于ICA或MCA M1闭塞导致中度或重度缺血性核心较大。所有患者卒中前均无残疾。综合结果显示,卒中后90天,EVT加医疗护理与单独医疗护理相比,功能独立性更高(RR 2.53, 95% CI [1.95, 3.29];P < 0.001;需要治疗的人数[NNT], 9, 95% CI[6,15])和减少残疾(常见优势比1.63,95% CI [1.38, 1.93];P < 0.001;NNT, 4[最小可能NNT, 2;最大可能NNT, 6])。EVT加医疗护理与单独医疗护理相比,需要持续护理或死亡的风险较低(RR 0.74, 95% CI [0.66, 0.84];P < 0.001;Nnt, 7, 95% ci[6,11])。EVT加医疗护理与单纯医疗护理相比,早期症状性颅内出血患者比例无显著性增高(RR 1.65, 95% CI [1.00, 2.70];P = 0.05)。EVT加医疗护理组和单独医疗护理组的死亡率差异无统计学意义(RR 0.86, 95% CI [0.72, 1.02];P = 0.08)。主要的限制包括大岩心的成像定义的可变性,以及分析中包含较大的中等岩心和大岩心。结论:在脑卒中前无残疾的急性脑卒中患者中,由于ICA或MCA M1闭塞而出现较大的中度或大缺血性核心,与单独的医疗护理相比,EVT加医疗护理可能与脑卒中后90天功能独立性的改善、残疾的减少以及严重残疾率或死亡率的降低有关。普洛斯彼罗注册号:CRD42024514605。
Endovascular thrombectomy in acute stroke with a large ischemic core: A systematic review and meta-analysis of randomized controlled trials.
Background: Endovascular thrombectomy (EVT) is the standard treatment for acute ischemic stroke due to internal carotid artery (ICA) or middle cerebral artery (MCA) M1 occlusion with a small ischemic core. However, the effect of EVT on acute stroke with a large ischemic core remains unclear. This study aimed to evaluate the association of EVT plus medical care versus medical care alone with outcomes in patients with acute stroke and a large ischemic core due to ICA or MCA M1 occlusion.
Methods and findings: PubMed, the Cochrane Central Register of Controlled Trials, and ClinicalTrials.gov were searched from January 1, 2000 to September 25, 2024. There were no language restrictions. Randomized controlled trials (RCTs) of patients with acute stroke and a large ischemic core that compared EVT plus medical care versus medical care alone were evaluated. We computed the random-effects estimate based on the inverse variance method. Risk ratio (RR) with 95% confidence interval (CI) was used to measure outcomes of EVT plus medical care versus medical care alone. The primary outcome was functional independence, defined as modified Rankin Scale (mRS) of 0-2 at 90 days post-stroke; and the lead secondary outcome was reduced disability, defined as ordinal shift of mRS. Safety outcomes were requiring constant care or death (mRS 5-6), death, and early symptomatic intracranial hemorrhage (sICH). Grading of Recommendations Assessment, Development and Evaluations (GRADE) was used to evaluate summaries of evidence for the outcomes. We included six RCTs comprising 1870 patients (826 females [44.2%]) with acute stroke and a larger moderate or large ischemic core due to ICA or MCA M1 occlusion. All patients were nondisabled before stroke. Pooled results showed that at 90 days post-stroke, EVT plus medical care, compared with medical care alone, was associated with greater functional independence (RR 2.53, 95% CI [1.95, 3.29]; p < 0.001; number needed to treat [NNT], 9, 95% CI [6,15]) and reduced disability (common odds ratio 1.63, 95% CI [1.38, 1.93]; p < 0.001; NNT, 4 [minimum possible NNT, 2; maximum possible NNT, 6]). EVT plus medical care, compared with medical care alone, was associated with a lower risk of requiring constant care or death (RR 0.74, 95% CI [0.66, 0.84]; p < 0.001; NNT, 7, 95% CI [6,11]). EVT plus medical care, compared with medical care alone, was associated with a nonsignificantly higher proportion of patients with early symptomatic intracranial hemorrhage (RR 1.65, 95% CI [1.00, 2.70]; p = 0.05). The rates of death were not significantly different between the EVT plus medical care and medical care alone groups (RR 0.86, 95% CI [0.72, 1.02]; p = 0.08). Main limitations include variability in imaging definitions of large core and inclusion of both larger moderate and large cores in the analysis.
Conclusions: Among patients with acute stroke and a larger moderate or large ischemic core due to ICA or MCA M1 occlusion who were nondisabled before stroke, EVT plus medical care, compared with medical care alone, may be associated with improved functional independence, reduced disability, and reduced rates of severe disability or death at 90 days post-stroke. PROSPERO registration number: CRD42024514605.
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