A multicenter, randomized, controlled study to investigate EXtending the time for Thrombolysis in Emergency Neurological Deficits with Intra-Arterial therapy (EXTEND-IA)

被引：123

作者：

Campbell, Bruce C. V. ^{[1
]}

Mitchell, Peter J. ^{[2
]}

Yan, Bernard ^{[1
]}

Parsons, Mark W. ^{[3
]}

Christensen, Soren ^{[2
]}

Churilov, Leonid ^{[4
]}

Dowling, Richard J. ^{[2
]}

Dewey, Helen ^{[5
]}

Brooks, Mark ^{[5
]}

Miteff, Ferdinand ^{[3
,6
]}

Levi, Christopher ^{[3
]}

Krause, Martin ^{[6
]}

Harrington, Timothy J. ^{[6
]}

Faulder, Kenneth C. ^{[6
]}

Steinfort, Brendan S. ^{[6
]}

Kleinig, Timothy ^{[7
]}

Scroop, Rebecca ^{[7
]}

Chryssidis, Steve ^{[7
]}

Barber, Alan ^{[8
]}

Hope, Ayton ^{[8
]}

Moriarty, Maurice ^{[8
]}

McGuinness, Ben ^{[8
]}

Wong, Andrew A. ^{[9
]}

Coulthard, Alan ^{[9
]}

Wijeratne, Tissa ^{[10
]}

Lee, Andrew ^{[11
]}

Jannes, Jim ^{[12
]}

Leyden, James ^{[13
]}

Phan, Thanh G. ^{[14
]}

Chong, Winston ^{[14
]}

Holt, Michael E. ^{[14
]}

Chandra, Ronil V. ^{[14
]}

Bladin, Christopher F. ^{[15
]}

Badve, Monica ^{[16
]}

Rice, Henry ^{[16
]}

de Villiers, Laetitia ^{[16
]}

Ma, Henry ^{[4
,14
]}

Desmond, Patricia M. ^{[2
]}

Donnan, Geoffrey A. ^{[1
]}

Davis, Stephen M. ^{[1
]}

机构：

[1] Univ Melbourne, Royal Melbourne Hosp, Dept Med & Neurol, Melbourne Brain Ctr, Parkville, Vic, Australia

[2] Royal Melbourne Hosp, Dept Radiol, Parkville, Vic 3050, Australia

[3] Univ Newcastle, John Hunter Hosp, Prior Res Ctr Brain & Mental Hlth Res, Newcastle, NSW 2300, Australia

[4] Univ Melbourne, Florey Inst Neurosci & Mental Hlth, Parkville, Vic 3052, Australia

[5] Austin Hosp, Austin Hlth, Heidelberg, Vic 3084, Australia

[6] Royal N Shore Hosp, St Leonards, NSW 2065, Australia

[7] Royal Adelaide Hosp, Adelaide, SA 5000, Australia

[8] Univ Auckland, Auckland Hosp, Auckland 1, New Zealand

[9] Royal Brisbane & Womens Hosp, Brisbane, Qld, Australia

[10] Western Hosp, Footscray, Vic, Australia

[11] Flinders Med Ctr, Adelaide, SA, Australia

[12] Queen Elizabeth Hosp, Adelaide, SA, Australia

[13] Lyell McEwin Hosp, Adelaide, SA, Australia

[14] Monash Univ, Monash Med Ctr, Clayton, Vic, Australia

[15] Monash Univ, Box Hill Hosp, Melbourne, Vic 3004, Australia

[16] Gold Coast Univ Hosp, Southport, Qld, Australia

来源：

INTERNATIONAL JOURNAL OF STROKE | 2014年 / 9卷 / 01期

基金：

英国医学研究理事会;

关键词：

CT perfusion; intra-arterial therapy; ischemic stroke; mechanical clot retrieval; solitaire stentriever device; thrombolysis; ACUTE ISCHEMIC-STROKE; PERFUSION-DIFFUSION MISMATCH; ENDOVASCULAR TREATMENT; EARLY RECANALIZATION; CLINICAL-RESPONSE; EVOLUTION DEFUSE; INFARCT GROWTH; WEIGHTED MRI; BLOOD-FLOW; ALTEPLASE;

D O I：

10.1111/ijs.12206

中图分类号：

R74 [神经病学与精神病学];

学科分类号：

摘要：

Background and Hypothesis Thrombolysis with tissue plasminogen activator is proven to reduce disability when given within 4.5 h of ischemic stroke onset. However, tissue plasminogen activator only succeeds in recanalizing large vessel arterial occlusion in a minority of patients. We hypothesized that anterior circulation ischemic stroke patients, selected with 'dual target' vessel occlusion and evidence of salvageable brain using computed tomography or magnetic resonance imaging 'mismatch' within 4.5 h of onset, would have improved reperfusion and early neurological improvement when treated with intra-arterial clot retrieval after intravenous tissue plasminogen activator compared with intravenous tissue plasminogen activator alone. Study Design EXTEND-IA is an investigator-initiated, phase II, multicenter prospective, randomized, open-label, blinded-endpoint study. Ischemic stroke patients receiving standard 0.9mg/kg intravenous tissue plasminogen activator within 4.5 h of stroke onset who have good prestroke functional status (modified Rankin Scale <2, no upper age limit) will undergo multimodal computed tomography or magnetic resonance imaging. Patients who also meet dual target imaging criteria: vessel occlusion (internal carotid or middle cerebral artery) and mismatch (perfusion lesion:ischemic core mismatch ratio >1.2, absolute mismatch >10ml, ischemic core volume <70ml) will be randomized to either clot retrieval with the Solitaire FR device after full dose intravenous tissue plasminogen activator, or tissue plasminogen activator alone. Study Outcomes The coprimary outcome measure will be reperfusion at 24 h and favorable clinical response (reduction in National Institutes of Health Stroke Scale by >= 8 points or reaching 0-1) at day 3. Secondary outcomes include modified Rankin Scale at day 90, death, and symptomatic intracranial hemorrhage.

引用

页码：126 / 132

页数：7

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