Thrombectomy for anterior circulation stroke beyond 6 h from time last known well (AURORA): a systematic review and individual patient data meta-analysis

Trials examining the benefit of thrombectomy in anterior circulation proximal large vessel occlusion stroke have enrolled patients considered to have salvageable brain tissue, who were randomly assigned beyond 6 h and (depending on study protocol) up to 24 h from time last seen well. We aimed to est...

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Veröffentlicht in:The Lancet (British edition) 2022-01, Vol.399 (10321), p.249-258
Hauptverfasser: Jovin, Tudor G, Nogueira, Raul G, Lansberg, Maarten G, Demchuk, Andrew M, Martins, Sheila O, Mocco, J, Ribo, Marc, Jadhav, Ashutosh P, Ortega-Gutierrez, Santiago, Hill, Michael D, Lima, Fabricio O, Haussen, Diogo C, Brown, Scott, Goyal, Mayank, Siddiqui, Adnan H, Heit, Jeremy J, Menon, Bijoy K, Kemp, Stephanie, Budzik, Ron, Urra, Xabier, Marks, Michael P, Costalat, Vincent, Liebeskind, David S, Albers, Gregory W
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container_issue 10321
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container_title The Lancet (British edition)
container_volume 399
creator Jovin, Tudor G
Nogueira, Raul G
Lansberg, Maarten G
Demchuk, Andrew M
Martins, Sheila O
Mocco, J
Ribo, Marc
Jadhav, Ashutosh P
Ortega-Gutierrez, Santiago
Hill, Michael D
Lima, Fabricio O
Haussen, Diogo C
Brown, Scott
Goyal, Mayank
Siddiqui, Adnan H
Heit, Jeremy J
Menon, Bijoy K
Kemp, Stephanie
Budzik, Ron
Urra, Xabier
Marks, Michael P
Costalat, Vincent
Liebeskind, David S
Albers, Gregory W
description Trials examining the benefit of thrombectomy in anterior circulation proximal large vessel occlusion stroke have enrolled patients considered to have salvageable brain tissue, who were randomly assigned beyond 6 h and (depending on study protocol) up to 24 h from time last seen well. We aimed to estimate the benefit of thrombectomy overall and in prespecified subgroups through individual patient data meta-analysis. We did a systematic review and individual patient data meta-analysis between Jan 1, 2010, and March 1, 2021, of randomised controlled trials of endovascular stroke therapy. In the Analysis Of Pooled Data From Randomized Studies Of Thrombectomy More Than 6 Hours After Last Known Well (AURORA) collaboration, the primary outcome was disability on the modified Rankin Scale (mRS) at 90 days, analysed by ordinal logistic regression. Key safety outcomes were symptomatic intracerebral haemorrhage and mortality within 90 days. Patient level data from 505 individuals (n=266 intervention, n=239 control; mean age 68·6 years [SD 13·7], 259 [51·3%] women) were included from six trials that met inclusion criteria of 17 screened published randomised trials. Primary outcome analysis showed a benefit of thrombectomy with an unadjusted common odds ratio (OR) of 2·42 (95% CI 1·76–3·33; p
doi_str_mv 10.1016/S0140-6736(21)01341-6
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We aimed to estimate the benefit of thrombectomy overall and in prespecified subgroups through individual patient data meta-analysis. We did a systematic review and individual patient data meta-analysis between Jan 1, 2010, and March 1, 2021, of randomised controlled trials of endovascular stroke therapy. In the Analysis Of Pooled Data From Randomized Studies Of Thrombectomy More Than 6 Hours After Last Known Well (AURORA) collaboration, the primary outcome was disability on the modified Rankin Scale (mRS) at 90 days, analysed by ordinal logistic regression. Key safety outcomes were symptomatic intracerebral haemorrhage and mortality within 90 days. Patient level data from 505 individuals (n=266 intervention, n=239 control; mean age 68·6 years [SD 13·7], 259 [51·3%] women) were included from six trials that met inclusion criteria of 17 screened published randomised trials. Primary outcome analysis showed a benefit of thrombectomy with an unadjusted common odds ratio (OR) of 2·42 (95% CI 1·76–3·33; p&lt;0·0001) and an adjusted common OR (for age, gender, baseline stroke severity, extent of infarction on baseline head CT, and time from onset to random assignment) of 2·54 (1·83–3·54; p&lt;0·0001). Thrombectomy was associated with higher rates of independence in activities of daily living (mRS 0–2) than best medical therapy alone (122 [45·9%] of 266 vs 46 [19·3%] of 238; p&lt;0·0001). No significant difference between intervention and control groups was found when analysing either 90-day mortality (44 [16·5%] of 266 vs 46 [19·3%] of 238) or symptomatic intracerebral haemorrhage (14 [5·3%] of 266 vs eight [3·3%] of 239). No heterogeneity of treatment effect was noted across subgroups defined by age, gender, baseline stroke severity, vessel occlusion site, baseline Alberta Stroke Program Early CT Score, and mode of presentation; treatment effect was stronger in patients randomly assigned within 12–24 h (common OR 5·86 [95% CI 3·14–10·94]) than those randomly assigned within 6–12 h (1·76 [1·18–2·62]; pinteraction=0·0087). These findings strengthen the evidence for benefit of endovascular thrombectomy in patients with evidence of reversible cerebral ischaemia across the 6–24 h time window and are relevant to clinical practice. Our findings suggest that in these patients, thrombectomy should not be withheld on the basis of mode of presentation or of the point in time of presentation within the 6–24 h time window. Stryker Neurovascular.</description><identifier>ISSN: 0140-6736</identifier><identifier>EISSN: 1474-547X</identifier><identifier>DOI: 10.1016/S0140-6736(21)01341-6</identifier><identifier>PMID: 34774198</identifier><language>eng</language><publisher>England: Elsevier Ltd</publisher><subject>Activities of daily living ; Age ; Cardiovascular system ; Cerebral blood flow ; Cerebral Hemorrhage - epidemiology ; Cerebral Hemorrhage - etiology ; Cerebral infarction ; Clinical medicine ; Clinical trials ; Data analysis ; Endovascular Procedures - adverse effects ; Endovascular Procedures - methods ; Endovascular Procedures - statistics &amp; numerical data ; Estimates ; Gender ; Health services ; Hemorrhage ; Heterogeneity ; Humans ; Ischemia ; Meta-analysis ; Mortality ; Occlusion ; Patients ; Postoperative Hemorrhage - epidemiology ; Postoperative Hemorrhage - etiology ; Randomized Controlled Trials as Topic ; Stroke ; Subgroups ; Systematic review ; Thrombectomy - adverse effects ; Thrombectomy - methods ; Thrombectomy - statistics &amp; numerical data ; Thrombotic Stroke - mortality ; Thrombotic Stroke - surgery ; Time-to-Treatment ; Treatment Outcome ; Windows (intervals)</subject><ispartof>The Lancet (British edition), 2022-01, Vol.399 (10321), p.249-258</ispartof><rights>2022 Elsevier Ltd</rights><rights>Copyright © 2022 Elsevier Ltd. All rights reserved.</rights><rights>2022. Elsevier Ltd</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c426t-bc596232d5bf14cecb73b0416e5389b0ee43c294574bb9e457c665d17414a9e03</citedby><cites>FETCH-LOGICAL-c426t-bc596232d5bf14cecb73b0416e5389b0ee43c294574bb9e457c665d17414a9e03</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://www.sciencedirect.com/science/article/pii/S0140673621013416$$EHTML$$P50$$Gelsevier$$H</linktohtml><link.rule.ids>314,776,780,3537,27901,27902,65306</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/34774198$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Jovin, Tudor G</creatorcontrib><creatorcontrib>Nogueira, Raul G</creatorcontrib><creatorcontrib>Lansberg, Maarten G</creatorcontrib><creatorcontrib>Demchuk, Andrew M</creatorcontrib><creatorcontrib>Martins, Sheila O</creatorcontrib><creatorcontrib>Mocco, J</creatorcontrib><creatorcontrib>Ribo, Marc</creatorcontrib><creatorcontrib>Jadhav, Ashutosh P</creatorcontrib><creatorcontrib>Ortega-Gutierrez, Santiago</creatorcontrib><creatorcontrib>Hill, Michael D</creatorcontrib><creatorcontrib>Lima, Fabricio O</creatorcontrib><creatorcontrib>Haussen, Diogo C</creatorcontrib><creatorcontrib>Brown, Scott</creatorcontrib><creatorcontrib>Goyal, Mayank</creatorcontrib><creatorcontrib>Siddiqui, Adnan H</creatorcontrib><creatorcontrib>Heit, Jeremy J</creatorcontrib><creatorcontrib>Menon, Bijoy K</creatorcontrib><creatorcontrib>Kemp, Stephanie</creatorcontrib><creatorcontrib>Budzik, Ron</creatorcontrib><creatorcontrib>Urra, Xabier</creatorcontrib><creatorcontrib>Marks, Michael P</creatorcontrib><creatorcontrib>Costalat, Vincent</creatorcontrib><creatorcontrib>Liebeskind, David S</creatorcontrib><creatorcontrib>Albers, Gregory W</creatorcontrib><title>Thrombectomy for anterior circulation stroke beyond 6 h from time last known well (AURORA): a systematic review and individual patient data meta-analysis</title><title>The Lancet (British edition)</title><addtitle>Lancet</addtitle><description>Trials examining the benefit of thrombectomy in anterior circulation proximal large vessel occlusion stroke have enrolled patients considered to have salvageable brain tissue, who were randomly assigned beyond 6 h and (depending on study protocol) up to 24 h from time last seen well. We aimed to estimate the benefit of thrombectomy overall and in prespecified subgroups through individual patient data meta-analysis. We did a systematic review and individual patient data meta-analysis between Jan 1, 2010, and March 1, 2021, of randomised controlled trials of endovascular stroke therapy. In the Analysis Of Pooled Data From Randomized Studies Of Thrombectomy More Than 6 Hours After Last Known Well (AURORA) collaboration, the primary outcome was disability on the modified Rankin Scale (mRS) at 90 days, analysed by ordinal logistic regression. Key safety outcomes were symptomatic intracerebral haemorrhage and mortality within 90 days. Patient level data from 505 individuals (n=266 intervention, n=239 control; mean age 68·6 years [SD 13·7], 259 [51·3%] women) were included from six trials that met inclusion criteria of 17 screened published randomised trials. Primary outcome analysis showed a benefit of thrombectomy with an unadjusted common odds ratio (OR) of 2·42 (95% CI 1·76–3·33; p&lt;0·0001) and an adjusted common OR (for age, gender, baseline stroke severity, extent of infarction on baseline head CT, and time from onset to random assignment) of 2·54 (1·83–3·54; p&lt;0·0001). Thrombectomy was associated with higher rates of independence in activities of daily living (mRS 0–2) than best medical therapy alone (122 [45·9%] of 266 vs 46 [19·3%] of 238; p&lt;0·0001). No significant difference between intervention and control groups was found when analysing either 90-day mortality (44 [16·5%] of 266 vs 46 [19·3%] of 238) or symptomatic intracerebral haemorrhage (14 [5·3%] of 266 vs eight [3·3%] of 239). No heterogeneity of treatment effect was noted across subgroups defined by age, gender, baseline stroke severity, vessel occlusion site, baseline Alberta Stroke Program Early CT Score, and mode of presentation; treatment effect was stronger in patients randomly assigned within 12–24 h (common OR 5·86 [95% CI 3·14–10·94]) than those randomly assigned within 6–12 h (1·76 [1·18–2·62]; pinteraction=0·0087). These findings strengthen the evidence for benefit of endovascular thrombectomy in patients with evidence of reversible cerebral ischaemia across the 6–24 h time window and are relevant to clinical practice. Our findings suggest that in these patients, thrombectomy should not be withheld on the basis of mode of presentation or of the point in time of presentation within the 6–24 h time window. Stryker Neurovascular.</description><subject>Activities of daily living</subject><subject>Age</subject><subject>Cardiovascular system</subject><subject>Cerebral blood flow</subject><subject>Cerebral Hemorrhage - epidemiology</subject><subject>Cerebral Hemorrhage - etiology</subject><subject>Cerebral infarction</subject><subject>Clinical medicine</subject><subject>Clinical trials</subject><subject>Data analysis</subject><subject>Endovascular Procedures - adverse effects</subject><subject>Endovascular Procedures - methods</subject><subject>Endovascular Procedures - statistics &amp; numerical data</subject><subject>Estimates</subject><subject>Gender</subject><subject>Health services</subject><subject>Hemorrhage</subject><subject>Heterogeneity</subject><subject>Humans</subject><subject>Ischemia</subject><subject>Meta-analysis</subject><subject>Mortality</subject><subject>Occlusion</subject><subject>Patients</subject><subject>Postoperative Hemorrhage - epidemiology</subject><subject>Postoperative Hemorrhage - etiology</subject><subject>Randomized Controlled Trials as Topic</subject><subject>Stroke</subject><subject>Subgroups</subject><subject>Systematic review</subject><subject>Thrombectomy - adverse effects</subject><subject>Thrombectomy - methods</subject><subject>Thrombectomy - statistics &amp; 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Medical Complete (Alumni)</collection><collection>Nursing &amp; Allied Health Database (Alumni Edition)</collection><collection>ProQuest Newsstand Professional</collection><collection>ProQuest Biological Science Collection</collection><collection>Consumer Health Database</collection><collection>Health &amp; Medical Collection (Alumni Edition)</collection><collection>Healthcare Administration Database</collection><collection>Medical Database</collection><collection>ProQuest Psychology</collection><collection>Research Library</collection><collection>Science Database</collection><collection>Algology Mycology and Protozoology Abstracts (Microbiology C)</collection><collection>Biological Science Database</collection><collection>Research Library (Corporate)</collection><collection>Nursing &amp; Allied Health Premium</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>ProQuest One Psychology</collection><collection>ProQuest Central Basic</collection><collection>SIRS Editorial</collection><collection>MEDLINE - Academic</collection><jtitle>The Lancet (British edition)</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Jovin, Tudor G</au><au>Nogueira, Raul G</au><au>Lansberg, Maarten G</au><au>Demchuk, Andrew M</au><au>Martins, Sheila O</au><au>Mocco, J</au><au>Ribo, Marc</au><au>Jadhav, Ashutosh P</au><au>Ortega-Gutierrez, Santiago</au><au>Hill, Michael D</au><au>Lima, Fabricio O</au><au>Haussen, Diogo C</au><au>Brown, Scott</au><au>Goyal, Mayank</au><au>Siddiqui, Adnan H</au><au>Heit, Jeremy J</au><au>Menon, Bijoy K</au><au>Kemp, Stephanie</au><au>Budzik, Ron</au><au>Urra, Xabier</au><au>Marks, Michael P</au><au>Costalat, Vincent</au><au>Liebeskind, David S</au><au>Albers, Gregory W</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Thrombectomy for anterior circulation stroke beyond 6 h from time last known well (AURORA): a systematic review and individual patient data meta-analysis</atitle><jtitle>The Lancet (British edition)</jtitle><addtitle>Lancet</addtitle><date>2022-01-15</date><risdate>2022</risdate><volume>399</volume><issue>10321</issue><spage>249</spage><epage>258</epage><pages>249-258</pages><issn>0140-6736</issn><eissn>1474-547X</eissn><abstract>Trials examining the benefit of thrombectomy in anterior circulation proximal large vessel occlusion stroke have enrolled patients considered to have salvageable brain tissue, who were randomly assigned beyond 6 h and (depending on study protocol) up to 24 h from time last seen well. We aimed to estimate the benefit of thrombectomy overall and in prespecified subgroups through individual patient data meta-analysis. We did a systematic review and individual patient data meta-analysis between Jan 1, 2010, and March 1, 2021, of randomised controlled trials of endovascular stroke therapy. In the Analysis Of Pooled Data From Randomized Studies Of Thrombectomy More Than 6 Hours After Last Known Well (AURORA) collaboration, the primary outcome was disability on the modified Rankin Scale (mRS) at 90 days, analysed by ordinal logistic regression. Key safety outcomes were symptomatic intracerebral haemorrhage and mortality within 90 days. Patient level data from 505 individuals (n=266 intervention, n=239 control; mean age 68·6 years [SD 13·7], 259 [51·3%] women) were included from six trials that met inclusion criteria of 17 screened published randomised trials. Primary outcome analysis showed a benefit of thrombectomy with an unadjusted common odds ratio (OR) of 2·42 (95% CI 1·76–3·33; p&lt;0·0001) and an adjusted common OR (for age, gender, baseline stroke severity, extent of infarction on baseline head CT, and time from onset to random assignment) of 2·54 (1·83–3·54; p&lt;0·0001). Thrombectomy was associated with higher rates of independence in activities of daily living (mRS 0–2) than best medical therapy alone (122 [45·9%] of 266 vs 46 [19·3%] of 238; p&lt;0·0001). No significant difference between intervention and control groups was found when analysing either 90-day mortality (44 [16·5%] of 266 vs 46 [19·3%] of 238) or symptomatic intracerebral haemorrhage (14 [5·3%] of 266 vs eight [3·3%] of 239). No heterogeneity of treatment effect was noted across subgroups defined by age, gender, baseline stroke severity, vessel occlusion site, baseline Alberta Stroke Program Early CT Score, and mode of presentation; treatment effect was stronger in patients randomly assigned within 12–24 h (common OR 5·86 [95% CI 3·14–10·94]) than those randomly assigned within 6–12 h (1·76 [1·18–2·62]; pinteraction=0·0087). These findings strengthen the evidence for benefit of endovascular thrombectomy in patients with evidence of reversible cerebral ischaemia across the 6–24 h time window and are relevant to clinical practice. Our findings suggest that in these patients, thrombectomy should not be withheld on the basis of mode of presentation or of the point in time of presentation within the 6–24 h time window. Stryker Neurovascular.</abstract><cop>England</cop><pub>Elsevier Ltd</pub><pmid>34774198</pmid><doi>10.1016/S0140-6736(21)01341-6</doi><tpages>10</tpages></addata></record>
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identifier ISSN: 0140-6736
ispartof The Lancet (British edition), 2022-01, Vol.399 (10321), p.249-258
issn 0140-6736
1474-547X
language eng
recordid cdi_proquest_miscellaneous_2597814656
source MEDLINE; Elsevier ScienceDirect Journals
subjects Activities of daily living
Age
Cardiovascular system
Cerebral blood flow
Cerebral Hemorrhage - epidemiology
Cerebral Hemorrhage - etiology
Cerebral infarction
Clinical medicine
Clinical trials
Data analysis
Endovascular Procedures - adverse effects
Endovascular Procedures - methods
Endovascular Procedures - statistics & numerical data
Estimates
Gender
Health services
Hemorrhage
Heterogeneity
Humans
Ischemia
Meta-analysis
Mortality
Occlusion
Patients
Postoperative Hemorrhage - epidemiology
Postoperative Hemorrhage - etiology
Randomized Controlled Trials as Topic
Stroke
Subgroups
Systematic review
Thrombectomy - adverse effects
Thrombectomy - methods
Thrombectomy - statistics & numerical data
Thrombotic Stroke - mortality
Thrombotic Stroke - surgery
Time-to-Treatment
Treatment Outcome
Windows (intervals)
title Thrombectomy for anterior circulation stroke beyond 6 h from time last known well (AURORA): a systematic review and individual patient data meta-analysis
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