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联合静脉溶栓与血管内取栓治疗与单纯血管内取栓治疗急性缺血性脑卒中的对比:SWIFT 和 STAR 研究的汇总分析。

Combined Intravenous Thrombolysis and Thrombectomy vs Thrombectomy Alone for Acute Ischemic Stroke: A Pooled Analysis of the SWIFT and STAR Studies.

机构信息

Department of Neurology, University of Amsterdam, Academic Medical Center, Amsterdam, the Netherlands.

Neurovascular Imaging Research Core and the UCLA (University of California, Los Angeles) Stroke Center, Los Angeles.

出版信息

JAMA Neurol. 2017 Mar 1;74(3):268-274. doi: 10.1001/jamaneurol.2016.5374.

Abstract

IMPORTANCE

Mechanical thrombectomy (MT) improves clinical outcomes in patients with acute ischemic stroke (AIS) caused by a large vessel occlusion. However, it is not known whether intravenous thrombolysis (IVT) is of added benefit in patients undergoing MT.

OBJECTIVE

To examine whether treatment with IVT before MT with a stent retriever is beneficial in patients undergoing MT.

DESIGN, SETTING, AND PARTICIPANTS: This post hoc analysis used data from 291 patients treated with MT included in 2 large, multicenter, prospective clinical trials that evaluated MT for AIS (Solitaire With the Intention for Thrombectomy performed from January 1, 2010, through December 31, 2011, and Solitaire Flow Restoration Thrombectomy for Acute Revascularization from January 1, 2010, through December 31, 2012). An independent core laboratory scored the radiologic outcomes in each trial.

INTERVENTIONS

Patients were treated with IVT with tissue plasminogen activator followed by MT (IVT and MT group) with the use of a stent retriever or MT with a stent retriever alone (MT group).

MAIN OUTCOMES AND MEASURES

Successful reperfusion, functional independence (modified Rankin Scale score of 0-2) and mortality at 90 days, symptomatic intracranial hemorrhage, emboli to new territory, and vasospasm were compared.

RESULTS

Of 291 patients included in the analysis, 160 (55.0%) underwent IVT and MT (mean [SD] age, 67 [13] years; 97 female [60.6%]), and 131 (45.0%) underwent MT alone (mean [SD] age, 69 [12] years; 71 [55.7%] female). Median Alberta Stroke Program Early CT Score at baseline was lower in the IVT and MT group (8 vs 9, P = .04). There was no statistically significant difference in the duration from symptom onset to groin puncture (254 minutes for the IVT and MT group vs 262 minutes for the MT group, P = .10). The number of passes, rate of successful reperfusion, functional independence at 90 days, mortality at 90 days, and emboli to new territory were also similar among groups. Symptomatic intracranial hemorrhage (1% vs 4%) and parenchymal hemorrhages type 1 (1% vs 3%) or type 2 (1% vs 2%) did not differ significantly (P = .25). Vasospasm occurred more often in patients who received IVT and MT vs MT alone (27% vs 14%, P = .006). In multivariate analysis, no statistically significant association was observed between IVT and MT vs MT alone for any of the outcomes.

CONCLUSIONS AND RELEVANCE

The results indicate that treatment of patients experiencing AIS due to a large vessel occlusion with IVT before MT does not appear to provide a clinical benefit over MT alone. A randomized clinical trial seems warranted.

TRIAL REGISTRATION

clinicaltrials.gov Identifiers: NCT01054560 and NCT01327989.

摘要

重要性

机械血栓切除术(MT)可改善由大血管闭塞引起的急性缺血性脑卒中(AIS)患者的临床结局。然而,目前尚不清楚在接受 MT 的患者中静脉溶栓(IVT)是否具有额外益处。

目的

研究在接受支架取栓的 MT 前是否可从 IVT 治疗中获益。

设计、地点和参与者:这一事后分析使用了 2 项大型多中心前瞻性临床试验中 291 例接受 MT 治疗的患者的数据,这些试验评估了 MT 治疗 AIS 的效果(2010 年 1 月 1 日至 2011 年 12 月 31 日期间进行的 Solitaire 伴取栓意图治疗和 2010 年 1 月 1 日至 2012 年 12 月 31 日期间进行的 Solitaire 血流恢复血栓切除术以实现急性血管再通)。每个试验的独立核心实验室对影像学结果进行评分。

干预措施

患者接受组织型纤溶酶原激活物静脉溶栓后行 MT(IVT 和 MT 组),使用支架取栓或单独 MT(MT 组)。

主要结局和测量指标

比较成功再灌注、90 天的功能独立性(改良 Rankin 量表评分 0-2)和死亡率、症状性颅内出血、新部位栓塞和血管痉挛。

结果

在纳入分析的 291 例患者中,160 例(55.0%)接受 IVT 和 MT(平均[标准差]年龄 67[13]岁;97 例女性[60.6%]),131 例(45.0%)接受单独 MT(平均[标准差]年龄 69[12]岁;71 例女性[55.7%])。基线时 Alberta Stroke Program Early CT 评分较低的患者在 IVT 和 MT 组(8 分 vs 9 分,P = .04)。从发病到股动脉穿刺的时间中位数无统计学差异(IVT 和 MT 组为 254 分钟,MT 组为 262 分钟,P = .10)。MT 组的血管再通率、功能独立性、90 天死亡率和新部位栓塞发生率也与 MT 组相似。症状性颅内出血(1% vs 4%)和实质内出血 1 型(1% vs 3%)或 2 型(1% vs 2%)的发生率无显著差异(P = .25)。与单独 MT 相比,接受 IVT 和 MT 的患者更常发生血管痉挛(27% vs 14%,P = .006)。多变量分析显示,与单独 MT 相比,IVT 和 MT 与任何结局之间均无统计学关联。

结论和相关性

结果表明,对于因大血管闭塞而发生 AIS 的患者,在 MT 前进行 IVT 治疗似乎不能提供优于单独 MT 的临床益处。似乎需要进行一项随机临床试验。

试验注册

clinicaltrials.gov 标识符:NCT01054560 和 NCT01327989。

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