Endovascular therapy for acute ischaemic stroke: the Pragmatic Ischaemic Stroke Thrombectomy Evaluation (PISTE) randomised, controlled trial

被引：261

作者：

Muir, Keith W. ^{[1
]}

Ford, Gary A. ^{[2
]}

Messow, Claudia-Martina ^{[3
]}

Ford, Ian ^{[3
]}

Murray, Alicia ^{[1
]}

Clifton, Andrew ^{[4
]}

Brown, Martin M. ^{[5
]}

Madigan, Jeremy ^{[4
]}

Lenthall, Rob ^{[6
]}

Robertson, Fergus ^{[5
]}

Dixit, Anand ^{[7
]}

Cloud, Geoffrey C. ^{[4
]}

Wardlaw, Joanna ^{[8
]}

Freeman, Janet

White, Philip ^{[7
]}

机构：

[1] Univ Glasgow, Queen Elizabeth Univ Hosp, Inst Neurosci & Psychol, Glasgow G51 4TF, Lanark, Scotland

[2] Univ Oxford, Oxford Univ Hosp NHS Trust, Div Med Sci, Oxford, England

[3] Univ Glasgow, Robertson Ctr Biostat, Glasgow, Lanark, Scotland

[4] St Georges Univ London, London, England

[5] UCL, UCL Inst Neurol, Ctr Stroke Res, London, England

[6] Queens Med Ctr, Dept Neuroradiol, Nottingham, England

[7] Newcastle Univ, Inst Neurosci, Newcastle Upon Tyne, Tyne & Wear, England

[8] Univ Edinburgh, Brain Res Imaging Ctr, Ctr Clin Brain Sci, Edinburgh, Midlothian, Scotland

来源：

JOURNAL OF NEUROLOGY NEUROSURGERY AND PSYCHIATRY | 2017年 / 88卷 / 01期

基金：

美国国家卫生研究院;

关键词：

INTRAVENOUS T-PA; INTERVENTIONAL MANAGEMENT; MECHANICAL THROMBECTOMY; CT ANGIOGRAPHY; RECANALIZATION; METAANALYSIS; RETRIEVER; ALTEPLASE; PERFUSION; OUTCOMES;

D O I：

10.1136/jnnp-2016-314117

中图分类号：

R74 [神经病学与精神病学];

学科分类号：

摘要：

Objective The Pragmatic Ischaemic Thrombectomy Evaluation (PISTE) trial was a multicentre, randomised, controlled clinical trial comparing intravenous thrombolysis (IVT) alone with IVT and adjunctive intra-arterial mechanical thrombectomy (MT) in patients who had acute ischaemic stroke with large artery occlusive anterior circulation stroke confirmed on CT angiography (CTA). Design Eligible patients had IVT started within 4.5hours of stroke symptom onset. Those randomised to additional MT underwent thrombectomy using any Conformite Europeene (CE)-marked device, with target interval times for IVT start to arterial puncture of <90min. The primary outcome was the proportion of patients achieving independence defined by a modified Rankin Scale (mRS) score of 0-2 at day 90. Results Ten UK centres enrolled 65 patients between April 2013 and April 2015. Median National Institutes of Health Stroke Scale score was 16 (IQR 13-21). Median stroke onset to IVT start was 120min. In the intention-to-treat analysis, there was no significant difference in disability-free survival at day 90 with MT (absolute difference 11%, adjusted OR 2.12, 95% CI 0.65 to 6.94, p=0.20). Secondary analyses showed significantly greater likelihood of full neurological recovery (mRS 0-1) at day 90 (OR 7.6, 95% CI 1.6 to 37.2, p=0.010). In the per-protocol population (n=58), the primary and most secondary clinical outcomes significantly favoured MT (absolute difference in mRS 0-2 of 22% and adjusted OR 4.9, 95% CI 1.2 to 19.7, p=0.021). Conclusions The trial did not find a significant difference between treatment groups for the primary end point. However, the effect size was consistent with published data and across primary and secondary end points. Proceeding as fast as possible to MT after CTA confirmation of large artery occlusion on a background of intravenous alteplase is safe, improves excellent clinical outcomes and, in the per-protocol population, improves disability-free survival. Trial registration number NCT01745692; Results.

引用

页码：38 / 44

页数：7

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