Recombinant tissue plasminogen activator for acute ischaemic stroke: an updated systematic review and meta-analysis
Summary Background Recombinant tissue plasminogen activator (rt-PA, alteplase) improved functional outcome in patients treated soon after acute ischaemic stroke in randomised trials, but licensing is restrictive and use varies widely. The IST-3 trial adds substantial new data. We therefore assessed...
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| Veröffentlicht in: | The Lancet (British edition) 2012-06, Vol.379 (9834), p.2364-2372 |
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| creator | Wardlaw, Joanna M, Prof Murray, Veronica, Prof Berge, Eivind, Prof del Zoppo, Gregory, Prof Sandercock, Peter, Prof Lindley, Richard L, Prof Cohen, Geoff, PhD |
| description | Summary Background Recombinant tissue plasminogen activator (rt-PA, alteplase) improved functional outcome in patients treated soon after acute ischaemic stroke in randomised trials, but licensing is restrictive and use varies widely. The IST-3 trial adds substantial new data. We therefore assessed all the evidence from randomised trials for rt-PA in acute ischaemic stroke in an updated systematic review and meta-analysis. Methods We searched for randomised trials of intravenous rt-PA versus control given within 6 h of onset of acute ischaemic stroke up to March 30, 2012. We estimated summary odds ratios (ORs) and 95% CI in the primary analysis for prespecified outcomes within 7 days and at the final follow-up of all patients treated up to 6 h after stroke. Findings In up to 12 trials (7012 patients), rt-PA given within 6 h of stroke significantly increased the odds of being alive and independent (modified Rankin Scale, mRS 0–2) at final follow-up (1611/3483 [46·3%] vs 1434/3404 [42·1%], OR 1·17, 95% CI 1·06–1·29; p=0·001), absolute increase of 42 (19–66) per 1000 people treated, and favourable outcome (mRS 0–1) absolute increase of 55 (95% CI 33–77) per 1000. The benefit of rt-PA was greatest in patients treated within 3 h (mRS 0–2, 365/896 [40·7%] vs 280/883 [31·7%], 1·53, 1·26–1·86, p |
| doi_str_mv | 10.1016/S0140-6736(12)60738-7 |
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The IST-3 trial adds substantial new data. We therefore assessed all the evidence from randomised trials for rt-PA in acute ischaemic stroke in an updated systematic review and meta-analysis. Methods We searched for randomised trials of intravenous rt-PA versus control given within 6 h of onset of acute ischaemic stroke up to March 30, 2012. We estimated summary odds ratios (ORs) and 95% CI in the primary analysis for prespecified outcomes within 7 days and at the final follow-up of all patients treated up to 6 h after stroke. Findings In up to 12 trials (7012 patients), rt-PA given within 6 h of stroke significantly increased the odds of being alive and independent (modified Rankin Scale, mRS 0–2) at final follow-up (1611/3483 [46·3%] vs 1434/3404 [42·1%], OR 1·17, 95% CI 1·06–1·29; p=0·001), absolute increase of 42 (19–66) per 1000 people treated, and favourable outcome (mRS 0–1) absolute increase of 55 (95% CI 33–77) per 1000. The benefit of rt-PA was greatest in patients treated within 3 h (mRS 0–2, 365/896 [40·7%] vs 280/883 [31·7%], 1·53, 1·26–1·86, p<0·0001), absolute benefit of 90 (46–135) per 1000 people treated, and mRS 0–1 (283/896 [31·6%] vs 202/883 [22·9%], 1·61, 1·30–1·90; p<0·0001), absolute benefit 87 (46–128) per 1000 treated. Numbers of deaths within 7 days were increased (250/2807 [8·9%] vs 174/2728 [6·4%], 1·44, 1·18–1·76; p=0·0003), but by final follow-up the excess was no longer significant (679/3548 [19·1%] vs 640/3464 [18·5%], 1·06, 0·94–1·20; p=0·33). Symptomatic intracranial haemorrhage (272/3548 [7·7%] vs 63/3463 [1·8%], 3·72, 2·98–4·64; p<0·0001) accounted for most of the early excess deaths. Patients older than 80 years achieved similar benefit to those aged 80 years or younger, particularly when treated early. Interpretation The evidence indicates that intravenous rt-PA increased the proportion of patients who were alive with favourable outcome and alive and independent at final follow-up. The data strengthen previous evidence to treat patients as early as possible after acute ischaemic stroke, although some patients might benefit up to 6 h after stroke. Funding UK Medical Research Council, Stroke Association, University of Edinburgh, National Health Service Health Technology Assessment Programme, Swedish Heart-Lung Fund, AFA Insurances Stockholm (Arbetsmarknadens Partners Forsakringsbolag), Karolinska Institute, Marianne and Marcus Wallenberg Foundation, Research Council of Norway, Oslo University Hospital.</description><identifier>ISSN: 0140-6736</identifier><identifier>EISSN: 1474-547X</identifier><identifier>DOI: 10.1016/S0140-6736(12)60738-7</identifier><identifier>PMID: 22632907</identifier><identifier>CODEN: LANCAO</identifier><language>eng</language><publisher>Kidlington: Elsevier Ltd</publisher><subject>Biological and medical sciences ; biomedical research ; Brain Ischemia - drug therapy ; Clinical trials ; Fibrinolytic Agents - therapeutic use ; General aspects ; Health services ; hemorrhage ; Humans ; Internal Medicine ; intravenous injection ; Medical research ; Medical sciences ; Meetings ; meta-analysis ; Methods ; Miscellaneous ; Neurology ; odds ratio ; patients ; people ; Public health. Hygiene ; Public health. Hygiene-occupational medicine ; Randomized Controlled Trials as Topic - methods ; Recombinant Proteins - therapeutic use ; Stroke ; Stroke - drug therapy ; Studies ; Systematic review ; t-plasminogen activator ; Technology assessment ; Thrombolytic Therapy - methods ; Tissue Plasminogen Activator - therapeutic use ; Treatment Outcome ; Vascular diseases and vascular malformations of the nervous system</subject><ispartof>The Lancet (British edition), 2012-06, Vol.379 (9834), p.2364-2372</ispartof><rights>Elsevier Ltd</rights><rights>2012 Elsevier Ltd</rights><rights>2015 INIST-CNRS</rights><rights>Copyright © 2012 Elsevier Ltd. All rights reserved.</rights><rights>Copyright Elsevier Limited Jun 23-Jun 29, 2012</rights><rights>2012 Elsevier Ltd. All rights reserved. 2012 Elsevier Ltd</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c760t-b44b64c9e31ae069aba2bd8d1956c3d4fdaea0db7782fc72cdfc2e86b9c948263</citedby><cites>FETCH-LOGICAL-c760t-b44b64c9e31ae069aba2bd8d1956c3d4fdaea0db7782fc72cdfc2e86b9c948263</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://www.sciencedirect.com/science/article/pii/S0140673612607387$$EHTML$$P50$$Gelsevier$$Hfree_for_read</linktohtml><link.rule.ids>230,314,550,776,780,881,3537,27901,27902,65306</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=26074257$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/22632907$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink><backlink>$$Uhttp://kipublications.ki.se/Default.aspx?queryparsed=id:124769993$$DView record from Swedish Publication Index$$Hfree_for_read</backlink></links><search><creatorcontrib>Wardlaw, Joanna M, Prof</creatorcontrib><creatorcontrib>Murray, Veronica, Prof</creatorcontrib><creatorcontrib>Berge, Eivind, Prof</creatorcontrib><creatorcontrib>del Zoppo, Gregory, Prof</creatorcontrib><creatorcontrib>Sandercock, Peter, Prof</creatorcontrib><creatorcontrib>Lindley, Richard L, Prof</creatorcontrib><creatorcontrib>Cohen, Geoff, PhD</creatorcontrib><title>Recombinant tissue plasminogen activator for acute ischaemic stroke: an updated systematic review and meta-analysis</title><title>The Lancet (British edition)</title><addtitle>Lancet</addtitle><description>Summary Background Recombinant tissue plasminogen activator (rt-PA, alteplase) improved functional outcome in patients treated soon after acute ischaemic stroke in randomised trials, but licensing is restrictive and use varies widely. The IST-3 trial adds substantial new data. We therefore assessed all the evidence from randomised trials for rt-PA in acute ischaemic stroke in an updated systematic review and meta-analysis. Methods We searched for randomised trials of intravenous rt-PA versus control given within 6 h of onset of acute ischaemic stroke up to March 30, 2012. We estimated summary odds ratios (ORs) and 95% CI in the primary analysis for prespecified outcomes within 7 days and at the final follow-up of all patients treated up to 6 h after stroke. Findings In up to 12 trials (7012 patients), rt-PA given within 6 h of stroke significantly increased the odds of being alive and independent (modified Rankin Scale, mRS 0–2) at final follow-up (1611/3483 [46·3%] vs 1434/3404 [42·1%], OR 1·17, 95% CI 1·06–1·29; p=0·001), absolute increase of 42 (19–66) per 1000 people treated, and favourable outcome (mRS 0–1) absolute increase of 55 (95% CI 33–77) per 1000. The benefit of rt-PA was greatest in patients treated within 3 h (mRS 0–2, 365/896 [40·7%] vs 280/883 [31·7%], 1·53, 1·26–1·86, p<0·0001), absolute benefit of 90 (46–135) per 1000 people treated, and mRS 0–1 (283/896 [31·6%] vs 202/883 [22·9%], 1·61, 1·30–1·90; p<0·0001), absolute benefit 87 (46–128) per 1000 treated. Numbers of deaths within 7 days were increased (250/2807 [8·9%] vs 174/2728 [6·4%], 1·44, 1·18–1·76; p=0·0003), but by final follow-up the excess was no longer significant (679/3548 [19·1%] vs 640/3464 [18·5%], 1·06, 0·94–1·20; p=0·33). Symptomatic intracranial haemorrhage (272/3548 [7·7%] vs 63/3463 [1·8%], 3·72, 2·98–4·64; p<0·0001) accounted for most of the early excess deaths. Patients older than 80 years achieved similar benefit to those aged 80 years or younger, particularly when treated early. Interpretation The evidence indicates that intravenous rt-PA increased the proportion of patients who were alive with favourable outcome and alive and independent at final follow-up. The data strengthen previous evidence to treat patients as early as possible after acute ischaemic stroke, although some patients might benefit up to 6 h after stroke. Funding UK Medical Research Council, Stroke Association, University of Edinburgh, National Health Service Health Technology Assessment Programme, Swedish Heart-Lung Fund, AFA Insurances Stockholm (Arbetsmarknadens Partners Forsakringsbolag), Karolinska Institute, Marianne and Marcus Wallenberg Foundation, Research Council of Norway, Oslo University Hospital.</description><subject>Biological and medical sciences</subject><subject>biomedical research</subject><subject>Brain Ischemia - drug therapy</subject><subject>Clinical trials</subject><subject>Fibrinolytic Agents - therapeutic use</subject><subject>General aspects</subject><subject>Health services</subject><subject>hemorrhage</subject><subject>Humans</subject><subject>Internal Medicine</subject><subject>intravenous injection</subject><subject>Medical research</subject><subject>Medical sciences</subject><subject>Meetings</subject><subject>meta-analysis</subject><subject>Methods</subject><subject>Miscellaneous</subject><subject>Neurology</subject><subject>odds ratio</subject><subject>patients</subject><subject>people</subject><subject>Public health. 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PhD</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Recombinant tissue plasminogen activator for acute ischaemic stroke: an updated systematic review and meta-analysis</atitle><jtitle>The Lancet (British edition)</jtitle><addtitle>Lancet</addtitle><date>2012-06-23</date><risdate>2012</risdate><volume>379</volume><issue>9834</issue><spage>2364</spage><epage>2372</epage><pages>2364-2372</pages><issn>0140-6736</issn><eissn>1474-547X</eissn><coden>LANCAO</coden><abstract>Summary Background Recombinant tissue plasminogen activator (rt-PA, alteplase) improved functional outcome in patients treated soon after acute ischaemic stroke in randomised trials, but licensing is restrictive and use varies widely. The IST-3 trial adds substantial new data. We therefore assessed all the evidence from randomised trials for rt-PA in acute ischaemic stroke in an updated systematic review and meta-analysis. Methods We searched for randomised trials of intravenous rt-PA versus control given within 6 h of onset of acute ischaemic stroke up to March 30, 2012. We estimated summary odds ratios (ORs) and 95% CI in the primary analysis for prespecified outcomes within 7 days and at the final follow-up of all patients treated up to 6 h after stroke. Findings In up to 12 trials (7012 patients), rt-PA given within 6 h of stroke significantly increased the odds of being alive and independent (modified Rankin Scale, mRS 0–2) at final follow-up (1611/3483 [46·3%] vs 1434/3404 [42·1%], OR 1·17, 95% CI 1·06–1·29; p=0·001), absolute increase of 42 (19–66) per 1000 people treated, and favourable outcome (mRS 0–1) absolute increase of 55 (95% CI 33–77) per 1000. The benefit of rt-PA was greatest in patients treated within 3 h (mRS 0–2, 365/896 [40·7%] vs 280/883 [31·7%], 1·53, 1·26–1·86, p<0·0001), absolute benefit of 90 (46–135) per 1000 people treated, and mRS 0–1 (283/896 [31·6%] vs 202/883 [22·9%], 1·61, 1·30–1·90; p<0·0001), absolute benefit 87 (46–128) per 1000 treated. Numbers of deaths within 7 days were increased (250/2807 [8·9%] vs 174/2728 [6·4%], 1·44, 1·18–1·76; p=0·0003), but by final follow-up the excess was no longer significant (679/3548 [19·1%] vs 640/3464 [18·5%], 1·06, 0·94–1·20; p=0·33). Symptomatic intracranial haemorrhage (272/3548 [7·7%] vs 63/3463 [1·8%], 3·72, 2·98–4·64; p<0·0001) accounted for most of the early excess deaths. Patients older than 80 years achieved similar benefit to those aged 80 years or younger, particularly when treated early. Interpretation The evidence indicates that intravenous rt-PA increased the proportion of patients who were alive with favourable outcome and alive and independent at final follow-up. The data strengthen previous evidence to treat patients as early as possible after acute ischaemic stroke, although some patients might benefit up to 6 h after stroke. Funding UK Medical Research Council, Stroke Association, University of Edinburgh, National Health Service Health Technology Assessment Programme, Swedish Heart-Lung Fund, AFA Insurances Stockholm (Arbetsmarknadens Partners Forsakringsbolag), Karolinska Institute, Marianne and Marcus Wallenberg Foundation, Research Council of Norway, Oslo University Hospital.</abstract><cop>Kidlington</cop><pub>Elsevier Ltd</pub><pmid>22632907</pmid><doi>10.1016/S0140-6736(12)60738-7</doi><tpages>9</tpages><oa>free_for_read</oa></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 0140-6736 |
| ispartof | The Lancet (British edition), 2012-06, Vol.379 (9834), p.2364-2372 |
| issn | 0140-6736 1474-547X |
| language | eng |
| recordid | cdi_swepub_primary_oai_swepub_ki_se_536873 |
| source | MEDLINE; Elsevier ScienceDirect Journals; SWEPUB Freely available online |
| subjects | Biological and medical sciences biomedical research Brain Ischemia - drug therapy Clinical trials Fibrinolytic Agents - therapeutic use General aspects Health services hemorrhage Humans Internal Medicine intravenous injection Medical research Medical sciences Meetings meta-analysis Methods Miscellaneous Neurology odds ratio patients people Public health. Hygiene Public health. Hygiene-occupational medicine Randomized Controlled Trials as Topic - methods Recombinant Proteins - therapeutic use Stroke Stroke - drug therapy Studies Systematic review t-plasminogen activator Technology assessment Thrombolytic Therapy - methods Tissue Plasminogen Activator - therapeutic use Treatment Outcome Vascular diseases and vascular malformations of the nervous system |
| title | Recombinant tissue plasminogen activator for acute ischaemic stroke: an updated systematic review and meta-analysis |
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