Treating Patients With 'Wake-Up' Stroke : The Experience of the AbESTT-II Trial
Approximately 10% to 20% of patients with a new stroke have symptoms present on awakening (wake-up stroke), but these persons are not treated with interventions to restore perfusion because the time of onset is not known. We elected to test the safety and possible efficacy of abciximab in treatment...
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| Veröffentlicht in: | Stroke (1970) 2008-12, Vol.39 (12), p.3277-3282 |
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| container_title | Stroke (1970) |
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| creator | ADAMS, Harold P LEIRA, Enrique C TOMER, James C BARNATHAN, Elliot PADGETT, Lakshmi EFFRON, Mark B HACKE, Werner |
| description | Approximately 10% to 20% of patients with a new stroke have symptoms present on awakening (wake-up stroke), but these persons are not treated with interventions to restore perfusion because the time of onset is not known. We elected to test the safety and possible efficacy of abciximab in treatment of enrolled subjects with wake-up stroke.
Abciximab in Emergency Stroke Treatment Trial-II (AbESTT-II) tested the usefulness of abciximab in improving outcomes after acute ischemic stroke and it prospectively tested an intervention in subjects that awakened with their stroke. We compared the outcomes among the subjects in the wake-up group with the other subjects in the trial.
Of the 801 subjects randomized in the trial, 43 (22 abciximab and 21 placebo) had wake-up strokes. Those with wake-up strokes had similar baseline characteristics as the other subjects except for a higher rate of a new stroke found on CT. Recruitment of patients into the wake-up group was halted early because of the rate of bleeding with abciximab exceeded the prespecified safety margins (3 of 22 [13.6%]) within 5 days or at discharge versus 15 of 375 (4.0%) for the nonwake-up group (P=0.07). Favorable outcomes at 3 months, as defined by scores on the modified Rankin Scale, among the wake-up group (4 of 43 [9.3%]) were worse than the nonwake-up group (221 of 758 [29.2%]; P=0.005).
Although the baseline characteristics of the wake-up group of subjects were similar to those of persons enrolled in the nonwake-up group, their outcomes were much poorer. Patients with wake-up stroke may not tolerate reperfusion therapies even when started within a short time of awakening. |
| doi_str_mv | 10.1161/STROKEAHA.107.508853 |
| format | Article |
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Abciximab in Emergency Stroke Treatment Trial-II (AbESTT-II) tested the usefulness of abciximab in improving outcomes after acute ischemic stroke and it prospectively tested an intervention in subjects that awakened with their stroke. We compared the outcomes among the subjects in the wake-up group with the other subjects in the trial.
Of the 801 subjects randomized in the trial, 43 (22 abciximab and 21 placebo) had wake-up strokes. Those with wake-up strokes had similar baseline characteristics as the other subjects except for a higher rate of a new stroke found on CT. Recruitment of patients into the wake-up group was halted early because of the rate of bleeding with abciximab exceeded the prespecified safety margins (3 of 22 [13.6%]) within 5 days or at discharge versus 15 of 375 (4.0%) for the nonwake-up group (P=0.07). Favorable outcomes at 3 months, as defined by scores on the modified Rankin Scale, among the wake-up group (4 of 43 [9.3%]) were worse than the nonwake-up group (221 of 758 [29.2%]; P=0.005).
Although the baseline characteristics of the wake-up group of subjects were similar to those of persons enrolled in the nonwake-up group, their outcomes were much poorer. Patients with wake-up stroke may not tolerate reperfusion therapies even when started within a short time of awakening.</description><identifier>ISSN: 0039-2499</identifier><identifier>EISSN: 1524-4628</identifier><identifier>DOI: 10.1161/STROKEAHA.107.508853</identifier><identifier>PMID: 18772451</identifier><identifier>CODEN: SJCCA7</identifier><language>eng</language><publisher>Hagerstown, MD: Lippincott Williams & Wilkins</publisher><subject>Abciximab ; Adult ; Aged ; Aged, 80 and over ; Antibodies, Monoclonal - administration & dosage ; Antibodies, Monoclonal - adverse effects ; Antibodies, Monoclonal - therapeutic use ; Biological and medical sciences ; Cerebral Hemorrhage - chemically induced ; Cerebral Hemorrhage - diagnosis ; Cerebral Hemorrhage - epidemiology ; Circadian Rhythm ; Comorbidity ; Double-Blind Method ; Female ; Fibrinolytic Agents - administration & dosage ; Fibrinolytic Agents - adverse effects ; Fibrinolytic Agents - therapeutic use ; Headache. Facial pains. Syncopes. Epilepsia. Intracranial hypertension. Brain oedema. Cerebral palsy ; Hemorrhage - chemically induced ; Hemorrhage - epidemiology ; Humans ; Immunoglobulin Fab Fragments - administration & dosage ; Immunoglobulin Fab Fragments - adverse effects ; Immunoglobulin Fab Fragments - therapeutic use ; Male ; Medical sciences ; Middle Aged ; Nervous system (semeiology, syndromes) ; Neurology ; Reperfusion ; Stroke - diagnosis ; Stroke - drug therapy ; Thrombolytic Therapy ; Time Factors ; Vascular diseases and vascular malformations of the nervous system</subject><ispartof>Stroke (1970), 2008-12, Vol.39 (12), p.3277-3282</ispartof><rights>2009 INIST-CNRS</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><cites>FETCH-LOGICAL-c321t-30fd4406f29ab6a57ca2264f76701e762cfc4ee9c4346b19483e858c244d28ce3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,776,780,3674,27901,27902</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=20976114$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/18772451$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>ADAMS, Harold P</creatorcontrib><creatorcontrib>LEIRA, Enrique C</creatorcontrib><creatorcontrib>TOMER, James C</creatorcontrib><creatorcontrib>BARNATHAN, Elliot</creatorcontrib><creatorcontrib>PADGETT, Lakshmi</creatorcontrib><creatorcontrib>EFFRON, Mark B</creatorcontrib><creatorcontrib>HACKE, Werner</creatorcontrib><creatorcontrib>AbESTT-II Investigators</creatorcontrib><title>Treating Patients With 'Wake-Up' Stroke : The Experience of the AbESTT-II Trial</title><title>Stroke (1970)</title><addtitle>Stroke</addtitle><description>Approximately 10% to 20% of patients with a new stroke have symptoms present on awakening (wake-up stroke), but these persons are not treated with interventions to restore perfusion because the time of onset is not known. We elected to test the safety and possible efficacy of abciximab in treatment of enrolled subjects with wake-up stroke.
Abciximab in Emergency Stroke Treatment Trial-II (AbESTT-II) tested the usefulness of abciximab in improving outcomes after acute ischemic stroke and it prospectively tested an intervention in subjects that awakened with their stroke. We compared the outcomes among the subjects in the wake-up group with the other subjects in the trial.
Of the 801 subjects randomized in the trial, 43 (22 abciximab and 21 placebo) had wake-up strokes. Those with wake-up strokes had similar baseline characteristics as the other subjects except for a higher rate of a new stroke found on CT. Recruitment of patients into the wake-up group was halted early because of the rate of bleeding with abciximab exceeded the prespecified safety margins (3 of 22 [13.6%]) within 5 days or at discharge versus 15 of 375 (4.0%) for the nonwake-up group (P=0.07). Favorable outcomes at 3 months, as defined by scores on the modified Rankin Scale, among the wake-up group (4 of 43 [9.3%]) were worse than the nonwake-up group (221 of 758 [29.2%]; P=0.005).
Although the baseline characteristics of the wake-up group of subjects were similar to those of persons enrolled in the nonwake-up group, their outcomes were much poorer. Patients with wake-up stroke may not tolerate reperfusion therapies even when started within a short time of awakening.</description><subject>Abciximab</subject><subject>Adult</subject><subject>Aged</subject><subject>Aged, 80 and over</subject><subject>Antibodies, Monoclonal - administration & dosage</subject><subject>Antibodies, Monoclonal - adverse effects</subject><subject>Antibodies, Monoclonal - therapeutic use</subject><subject>Biological and medical sciences</subject><subject>Cerebral Hemorrhage - chemically induced</subject><subject>Cerebral Hemorrhage - diagnosis</subject><subject>Cerebral Hemorrhage - epidemiology</subject><subject>Circadian Rhythm</subject><subject>Comorbidity</subject><subject>Double-Blind Method</subject><subject>Female</subject><subject>Fibrinolytic Agents - administration & dosage</subject><subject>Fibrinolytic Agents - adverse effects</subject><subject>Fibrinolytic Agents - therapeutic use</subject><subject>Headache. Facial pains. Syncopes. Epilepsia. Intracranial hypertension. Brain oedema. Cerebral palsy</subject><subject>Hemorrhage - chemically induced</subject><subject>Hemorrhage - epidemiology</subject><subject>Humans</subject><subject>Immunoglobulin Fab Fragments - administration & dosage</subject><subject>Immunoglobulin Fab Fragments - adverse effects</subject><subject>Immunoglobulin Fab Fragments - therapeutic use</subject><subject>Male</subject><subject>Medical sciences</subject><subject>Middle Aged</subject><subject>Nervous system (semeiology, syndromes)</subject><subject>Neurology</subject><subject>Reperfusion</subject><subject>Stroke - diagnosis</subject><subject>Stroke - drug therapy</subject><subject>Thrombolytic Therapy</subject><subject>Time Factors</subject><subject>Vascular diseases and vascular malformations of the nervous system</subject><issn>0039-2499</issn><issn>1524-4628</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2008</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNpFkF1LwzAYhYMobk7_gUhuZFed-XibpN6VUd1wMHEduyxplri6r5J0oP_eysa8OnB4zrl4ELqnZECpoE-z_GP6lqWjdECJHMREqZhfoC6NGUQgmLpEXUJ4EjFIkg66CeGLEMK4iq9RhyopGcS0i6a5t7qpdp_4vQ27awJeVM0K9xd6baN53cezxu_XFj_jfGVx9l1b32LG4r3DTdukZTbL82g8xrmv9OYWXTm9CfbulD00f8ny4SiaTF_Hw3QSGc5oE3HilgBEOJboUuhYGs2YACeFJNRKwYwzYG1igIMoaQKKWxUrwwCWTBnLewiOv8bvQ_DWFbWvttr_FJQUf36Ks5-2kcXRTzt7OM7qQ7m1y__RSUgLPJ4AHYzeOK93pgpnjpFECkqB_wI7AmwD</recordid><startdate>20081201</startdate><enddate>20081201</enddate><creator>ADAMS, Harold P</creator><creator>LEIRA, Enrique C</creator><creator>TOMER, James C</creator><creator>BARNATHAN, Elliot</creator><creator>PADGETT, Lakshmi</creator><creator>EFFRON, Mark B</creator><creator>HACKE, Werner</creator><general>Lippincott Williams & Wilkins</general><scope>IQODW</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope></search><sort><creationdate>20081201</creationdate><title>Treating Patients With 'Wake-Up' Stroke : The Experience of the AbESTT-II Trial</title><author>ADAMS, Harold P ; LEIRA, Enrique C ; TOMER, James C ; BARNATHAN, Elliot ; PADGETT, Lakshmi ; EFFRON, Mark B ; HACKE, Werner</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c321t-30fd4406f29ab6a57ca2264f76701e762cfc4ee9c4346b19483e858c244d28ce3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2008</creationdate><topic>Abciximab</topic><topic>Adult</topic><topic>Aged</topic><topic>Aged, 80 and over</topic><topic>Antibodies, Monoclonal - administration & dosage</topic><topic>Antibodies, Monoclonal - adverse effects</topic><topic>Antibodies, Monoclonal - therapeutic use</topic><topic>Biological and medical sciences</topic><topic>Cerebral Hemorrhage - chemically induced</topic><topic>Cerebral Hemorrhage - diagnosis</topic><topic>Cerebral Hemorrhage - epidemiology</topic><topic>Circadian Rhythm</topic><topic>Comorbidity</topic><topic>Double-Blind Method</topic><topic>Female</topic><topic>Fibrinolytic Agents - administration & dosage</topic><topic>Fibrinolytic Agents - adverse effects</topic><topic>Fibrinolytic Agents - therapeutic use</topic><topic>Headache. Facial pains. Syncopes. Epilepsia. Intracranial hypertension. Brain oedema. Cerebral palsy</topic><topic>Hemorrhage - chemically induced</topic><topic>Hemorrhage - epidemiology</topic><topic>Humans</topic><topic>Immunoglobulin Fab Fragments - administration & dosage</topic><topic>Immunoglobulin Fab Fragments - adverse effects</topic><topic>Immunoglobulin Fab Fragments - therapeutic use</topic><topic>Male</topic><topic>Medical sciences</topic><topic>Middle Aged</topic><topic>Nervous system (semeiology, syndromes)</topic><topic>Neurology</topic><topic>Reperfusion</topic><topic>Stroke - diagnosis</topic><topic>Stroke - drug therapy</topic><topic>Thrombolytic Therapy</topic><topic>Time Factors</topic><topic>Vascular diseases and vascular malformations of the nervous system</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>ADAMS, Harold P</creatorcontrib><creatorcontrib>LEIRA, Enrique C</creatorcontrib><creatorcontrib>TOMER, James C</creatorcontrib><creatorcontrib>BARNATHAN, Elliot</creatorcontrib><creatorcontrib>PADGETT, Lakshmi</creatorcontrib><creatorcontrib>EFFRON, Mark B</creatorcontrib><creatorcontrib>HACKE, Werner</creatorcontrib><creatorcontrib>AbESTT-II Investigators</creatorcontrib><collection>Pascal-Francis</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><jtitle>Stroke (1970)</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>ADAMS, Harold P</au><au>LEIRA, Enrique C</au><au>TOMER, James C</au><au>BARNATHAN, Elliot</au><au>PADGETT, Lakshmi</au><au>EFFRON, Mark B</au><au>HACKE, Werner</au><aucorp>AbESTT-II Investigators</aucorp><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Treating Patients With 'Wake-Up' Stroke : The Experience of the AbESTT-II Trial</atitle><jtitle>Stroke (1970)</jtitle><addtitle>Stroke</addtitle><date>2008-12-01</date><risdate>2008</risdate><volume>39</volume><issue>12</issue><spage>3277</spage><epage>3282</epage><pages>3277-3282</pages><issn>0039-2499</issn><eissn>1524-4628</eissn><coden>SJCCA7</coden><abstract>Approximately 10% to 20% of patients with a new stroke have symptoms present on awakening (wake-up stroke), but these persons are not treated with interventions to restore perfusion because the time of onset is not known. We elected to test the safety and possible efficacy of abciximab in treatment of enrolled subjects with wake-up stroke.
Abciximab in Emergency Stroke Treatment Trial-II (AbESTT-II) tested the usefulness of abciximab in improving outcomes after acute ischemic stroke and it prospectively tested an intervention in subjects that awakened with their stroke. We compared the outcomes among the subjects in the wake-up group with the other subjects in the trial.
Of the 801 subjects randomized in the trial, 43 (22 abciximab and 21 placebo) had wake-up strokes. Those with wake-up strokes had similar baseline characteristics as the other subjects except for a higher rate of a new stroke found on CT. Recruitment of patients into the wake-up group was halted early because of the rate of bleeding with abciximab exceeded the prespecified safety margins (3 of 22 [13.6%]) within 5 days or at discharge versus 15 of 375 (4.0%) for the nonwake-up group (P=0.07). Favorable outcomes at 3 months, as defined by scores on the modified Rankin Scale, among the wake-up group (4 of 43 [9.3%]) were worse than the nonwake-up group (221 of 758 [29.2%]; P=0.005).
Although the baseline characteristics of the wake-up group of subjects were similar to those of persons enrolled in the nonwake-up group, their outcomes were much poorer. Patients with wake-up stroke may not tolerate reperfusion therapies even when started within a short time of awakening.</abstract><cop>Hagerstown, MD</cop><pub>Lippincott Williams & Wilkins</pub><pmid>18772451</pmid><doi>10.1161/STROKEAHA.107.508853</doi><tpages>6</tpages></addata></record> |
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| ispartof | Stroke (1970), 2008-12, Vol.39 (12), p.3277-3282 |
| issn | 0039-2499 1524-4628 |
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| source | MEDLINE; American Heart Association Journals; EZB-FREE-00999 freely available EZB journals; Alma/SFX Local Collection; Journals@Ovid Complete |
| subjects | Abciximab Adult Aged Aged, 80 and over Antibodies, Monoclonal - administration & dosage Antibodies, Monoclonal - adverse effects Antibodies, Monoclonal - therapeutic use Biological and medical sciences Cerebral Hemorrhage - chemically induced Cerebral Hemorrhage - diagnosis Cerebral Hemorrhage - epidemiology Circadian Rhythm Comorbidity Double-Blind Method Female Fibrinolytic Agents - administration & dosage Fibrinolytic Agents - adverse effects Fibrinolytic Agents - therapeutic use Headache. Facial pains. Syncopes. Epilepsia. Intracranial hypertension. Brain oedema. Cerebral palsy Hemorrhage - chemically induced Hemorrhage - epidemiology Humans Immunoglobulin Fab Fragments - administration & dosage Immunoglobulin Fab Fragments - adverse effects Immunoglobulin Fab Fragments - therapeutic use Male Medical sciences Middle Aged Nervous system (semeiology, syndromes) Neurology Reperfusion Stroke - diagnosis Stroke - drug therapy Thrombolytic Therapy Time Factors Vascular diseases and vascular malformations of the nervous system |
| title | Treating Patients With 'Wake-Up' Stroke : The Experience of the AbESTT-II Trial |
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