Outcome and symptomatic bleeding complications of intravenous thrombolysis within 6 hours in MRI-selected Stroke patients: Comparison of a German multicenter Study with the pooled data of atlantis, ECASS, and ninds tPA trials
We compared outcome and symptomatic bleeding complications of intravenous tissue plasminogen activator (IV-tPA) within 6 hours of symptom onset in MRI-selected patients with acute middle cerebral artery infarction with the pooled data of the large stroke tPA trials. Patients were examined by perfusi...
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| Veröffentlicht in: | Stroke (1970) 2006-03, Vol.37 (3), p.852-858 |
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| creator | THOMALLA, Götz SCHWARK, Christian ZEUMER, Hermann WEILLER, Cornelius HACKE, Werner SCHELLINGER, Peter D RÖTHER, Joachim SOBESKY, Jan BLUHMKI, Erich FIEBACH, Jochen B FIEHLER, Jens WEBER, Olivier Zaro KUCINSKI, Thomas JUETTLER, Eric RINGLEB, Peter A |
| description | We compared outcome and symptomatic bleeding complications of intravenous tissue plasminogen activator (IV-tPA) within 6 hours of symptom onset in MRI-selected patients with acute middle cerebral artery infarction with the pooled data of the large stroke tPA trials.
Patients were examined by perfusion-weighted and diffusion-weighted imaging < or =6 hours. Within 3 hours, patients were treated according to Second European-Australasian Acute Stroke Study (ECASS II) criteria. After 3 to 6 hours, treatment with IV-tPA was performed based on MRI findings. Favorable outcome was assessed after 90 days using a dichotomized modified Rankin scale score of 0 to 1. Intracerebral bleeding complications were assessed on follow-up MRI or computed tomography. Data were compared with the pooled placebo and pooled tPA patients of the ATLANTIS, ECASS, and National Institute of Neurological Disorders and Stroke (NINDS) tPA trials.
From 174 MRI-selected tPA patients, 62% (n=108) were treated in < or =3 hours and 38% (n=66) after 3 to 6 hours. Favorable outcome was more frequent in MRI-selected tPA patients (48% [95% CI, 39 to 54]) compared with pooled placebo (33% [95% CI, 31 to 36]; P |
| doi_str_mv | 10.1161/01.STR.0000204120.79399.72 |
| format | Article |
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Patients were examined by perfusion-weighted and diffusion-weighted imaging < or =6 hours. Within 3 hours, patients were treated according to Second European-Australasian Acute Stroke Study (ECASS II) criteria. After 3 to 6 hours, treatment with IV-tPA was performed based on MRI findings. Favorable outcome was assessed after 90 days using a dichotomized modified Rankin scale score of 0 to 1. Intracerebral bleeding complications were assessed on follow-up MRI or computed tomography. Data were compared with the pooled placebo and pooled tPA patients of the ATLANTIS, ECASS, and National Institute of Neurological Disorders and Stroke (NINDS) tPA trials.
From 174 MRI-selected tPA patients, 62% (n=108) were treated in < or =3 hours and 38% (n=66) after 3 to 6 hours. Favorable outcome was more frequent in MRI-selected tPA patients (48% [95% CI, 39 to 54]) compared with pooled placebo (33% [95% CI, 31 to 36]; P<0.001) and pooled tPA patients (40% [95% CI, 37 to 42]; P=0.046). Odds ratios for favorable outcome in the MRI-selected tPA group were 1.82 (1.32 to 2.51) compared with the pooled placebo and 1.39 (1.01 to 1.92) compared with the pooled tPA group. The rate of symptomatic intracerebral hemorrhage in MRI-selected tPA patients (3% [95% CI, 0 to 5]) was lower than in the pooled tPA group (8% [95% CI, 7 to 10]; P=0.012) and comparable to the pooled placebo group (2% [95% CI, 1 to 3]; P=0.392).
This study supports that it is safe and effective to expand the time window for IV-tPA up to 6 hours in patients with tissue at risk as defined by MRI.</description><identifier>ISSN: 0039-2499</identifier><identifier>EISSN: 1524-4628</identifier><identifier>DOI: 10.1161/01.STR.0000204120.79399.72</identifier><identifier>PMID: 16439696</identifier><identifier>CODEN: SJCCA7</identifier><language>eng</language><publisher>Hagerstown, MD: Lippincott Williams & Wilkins</publisher><subject>Adolescent ; Adult ; Aged ; Aged, 80 and over ; Biological and medical sciences ; Blood. Blood coagulation. Reticuloendothelial system ; Cerebral Hemorrhage ; Clinical Trials as Topic ; Diffusion Magnetic Resonance Imaging - methods ; Female ; Germany ; Headache. Facial pains. Syncopes. Epilepsia. Intracranial hypertension. Brain oedema. Cerebral palsy ; Humans ; Infusions, Intravenous ; Magnetic Resonance Angiography - methods ; Magnetic Resonance Imaging - methods ; Male ; Medical sciences ; Middle Aged ; Nervous system (semeiology, syndromes) ; Neurology ; Odds Ratio ; Pharmacology. Drug treatments ; Placebos ; Stroke ; Thrombolytic Therapy - methods ; Time Factors ; Tissue Plasminogen Activator - administration & dosage ; Treatment Outcome ; Vascular diseases and vascular malformations of the nervous system</subject><ispartof>Stroke (1970), 2006-03, Vol.37 (3), p.852-858</ispartof><rights>2006 INIST-CNRS</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><cites>FETCH-LOGICAL-c325t-b33ee7c638618c87daccd898e66ca6023222469145a688f230e8b7d3b7c477b3</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=17573223$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/16439696$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>THOMALLA, Götz</creatorcontrib><creatorcontrib>SCHWARK, Christian</creatorcontrib><creatorcontrib>ZEUMER, Hermann</creatorcontrib><creatorcontrib>WEILLER, Cornelius</creatorcontrib><creatorcontrib>HACKE, Werner</creatorcontrib><creatorcontrib>SCHELLINGER, Peter D</creatorcontrib><creatorcontrib>RÖTHER, Joachim</creatorcontrib><creatorcontrib>SOBESKY, Jan</creatorcontrib><creatorcontrib>BLUHMKI, Erich</creatorcontrib><creatorcontrib>FIEBACH, Jochen B</creatorcontrib><creatorcontrib>FIEHLER, Jens</creatorcontrib><creatorcontrib>WEBER, Olivier Zaro</creatorcontrib><creatorcontrib>KUCINSKI, Thomas</creatorcontrib><creatorcontrib>JUETTLER, Eric</creatorcontrib><creatorcontrib>RINGLEB, Peter A</creatorcontrib><creatorcontrib>MRI in Acute Stroke Study Group of the German Competence Network Stroke</creatorcontrib><title>Outcome and symptomatic bleeding complications of intravenous thrombolysis within 6 hours in MRI-selected Stroke patients: Comparison of a German multicenter Study with the pooled data of atlantis, ECASS, and ninds tPA trials</title><title>Stroke (1970)</title><addtitle>Stroke</addtitle><description>We compared outcome and symptomatic bleeding complications of intravenous tissue plasminogen activator (IV-tPA) within 6 hours of symptom onset in MRI-selected patients with acute middle cerebral artery infarction with the pooled data of the large stroke tPA trials.
Patients were examined by perfusion-weighted and diffusion-weighted imaging < or =6 hours. Within 3 hours, patients were treated according to Second European-Australasian Acute Stroke Study (ECASS II) criteria. After 3 to 6 hours, treatment with IV-tPA was performed based on MRI findings. Favorable outcome was assessed after 90 days using a dichotomized modified Rankin scale score of 0 to 1. Intracerebral bleeding complications were assessed on follow-up MRI or computed tomography. Data were compared with the pooled placebo and pooled tPA patients of the ATLANTIS, ECASS, and National Institute of Neurological Disorders and Stroke (NINDS) tPA trials.
From 174 MRI-selected tPA patients, 62% (n=108) were treated in < or =3 hours and 38% (n=66) after 3 to 6 hours. Favorable outcome was more frequent in MRI-selected tPA patients (48% [95% CI, 39 to 54]) compared with pooled placebo (33% [95% CI, 31 to 36]; P<0.001) and pooled tPA patients (40% [95% CI, 37 to 42]; P=0.046). Odds ratios for favorable outcome in the MRI-selected tPA group were 1.82 (1.32 to 2.51) compared with the pooled placebo and 1.39 (1.01 to 1.92) compared with the pooled tPA group. The rate of symptomatic intracerebral hemorrhage in MRI-selected tPA patients (3% [95% CI, 0 to 5]) was lower than in the pooled tPA group (8% [95% CI, 7 to 10]; P=0.012) and comparable to the pooled placebo group (2% [95% CI, 1 to 3]; P=0.392).
This study supports that it is safe and effective to expand the time window for IV-tPA up to 6 hours in patients with tissue at risk as defined by MRI.</description><subject>Adolescent</subject><subject>Adult</subject><subject>Aged</subject><subject>Aged, 80 and over</subject><subject>Biological and medical sciences</subject><subject>Blood. Blood coagulation. Reticuloendothelial system</subject><subject>Cerebral Hemorrhage</subject><subject>Clinical Trials as Topic</subject><subject>Diffusion Magnetic Resonance Imaging - methods</subject><subject>Female</subject><subject>Germany</subject><subject>Headache. Facial pains. Syncopes. Epilepsia. Intracranial hypertension. Brain oedema. Cerebral palsy</subject><subject>Humans</subject><subject>Infusions, Intravenous</subject><subject>Magnetic Resonance Angiography - methods</subject><subject>Magnetic Resonance Imaging - methods</subject><subject>Male</subject><subject>Medical sciences</subject><subject>Middle Aged</subject><subject>Nervous system (semeiology, syndromes)</subject><subject>Neurology</subject><subject>Odds Ratio</subject><subject>Pharmacology. Drug treatments</subject><subject>Placebos</subject><subject>Stroke</subject><subject>Thrombolytic Therapy - methods</subject><subject>Time Factors</subject><subject>Tissue Plasminogen Activator - administration & dosage</subject><subject>Treatment Outcome</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>2006</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNpFkd2O0zAQhS0EYkvhFZCFBFeb4p_UTvauqpZlpUWLtr2PHGdCDYldbAfUx-VNmHYr1Tcj2ed8M-NDyAfOFpwr_pnxxWb7tGB4BCu5YAtdy7peaPGCzPhSlEWpRPWSzBiTdSHKur4ib1L6edTLavmaXHFVylrVakb-PU7ZhhGo8R1Nh3Gfw2iys7QdADrnf1B83Q_O4mXwiYaeOp-j-QM-TInmXQxjG4ZDcon-dXnnPFV0F6aYUEe_Pd0XCQawGTq6yTH8ArpHEvicbugaySa6FPwRa-gdxNF4Ok4DDoASiOiZusMJjK3QG8KApM5kc7Lkwfjs0jW9Xa82m-vTEt75Dgf7vqI5OjOkt-RVjwXeneucbL_cbtdfi4fHu_v16qGwUixz0UoJoK2SleKVrXRnrO2qugKlrFH4cUKIUtW8XBpVVb2QDKpWd7LVttS6lXPy6Rm7j-H3BCk3o0sWBpwQ8KcapTXjJXLm5OZZaGNIKULf7KMbTTw0nDXHfBvGG8y3ueTbnPJt9NH8_txlakfoLtZzoCj4eBaYZM3QR-OtSxedXmrcRMr_WXKzSA</recordid><startdate>20060301</startdate><enddate>20060301</enddate><creator>THOMALLA, Götz</creator><creator>SCHWARK, Christian</creator><creator>ZEUMER, Hermann</creator><creator>WEILLER, Cornelius</creator><creator>HACKE, Werner</creator><creator>SCHELLINGER, Peter D</creator><creator>RÖTHER, Joachim</creator><creator>SOBESKY, Jan</creator><creator>BLUHMKI, Erich</creator><creator>FIEBACH, Jochen B</creator><creator>FIEHLER, Jens</creator><creator>WEBER, Olivier Zaro</creator><creator>KUCINSKI, Thomas</creator><creator>JUETTLER, Eric</creator><creator>RINGLEB, Peter A</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><scope>7X8</scope></search><sort><creationdate>20060301</creationdate><title>Outcome and symptomatic bleeding complications of intravenous thrombolysis within 6 hours in MRI-selected Stroke patients: Comparison of a German multicenter Study with the pooled data of atlantis, ECASS, and ninds tPA trials</title><author>THOMALLA, Götz ; SCHWARK, Christian ; ZEUMER, Hermann ; WEILLER, Cornelius ; HACKE, Werner ; SCHELLINGER, Peter D ; RÖTHER, Joachim ; SOBESKY, Jan ; BLUHMKI, Erich ; FIEBACH, Jochen B ; FIEHLER, Jens ; WEBER, Olivier Zaro ; KUCINSKI, Thomas ; JUETTLER, Eric ; RINGLEB, Peter A</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c325t-b33ee7c638618c87daccd898e66ca6023222469145a688f230e8b7d3b7c477b3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2006</creationdate><topic>Adolescent</topic><topic>Adult</topic><topic>Aged</topic><topic>Aged, 80 and over</topic><topic>Biological and medical sciences</topic><topic>Blood. Blood coagulation. Reticuloendothelial system</topic><topic>Cerebral Hemorrhage</topic><topic>Clinical Trials as Topic</topic><topic>Diffusion Magnetic Resonance Imaging - methods</topic><topic>Female</topic><topic>Germany</topic><topic>Headache. Facial pains. Syncopes. Epilepsia. Intracranial hypertension. Brain oedema. Cerebral palsy</topic><topic>Humans</topic><topic>Infusions, Intravenous</topic><topic>Magnetic Resonance Angiography - methods</topic><topic>Magnetic Resonance Imaging - methods</topic><topic>Male</topic><topic>Medical sciences</topic><topic>Middle Aged</topic><topic>Nervous system (semeiology, syndromes)</topic><topic>Neurology</topic><topic>Odds Ratio</topic><topic>Pharmacology. Drug treatments</topic><topic>Placebos</topic><topic>Stroke</topic><topic>Thrombolytic Therapy - methods</topic><topic>Time Factors</topic><topic>Tissue Plasminogen Activator - administration & dosage</topic><topic>Treatment Outcome</topic><topic>Vascular diseases and vascular malformations of the nervous system</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>THOMALLA, Götz</creatorcontrib><creatorcontrib>SCHWARK, Christian</creatorcontrib><creatorcontrib>ZEUMER, Hermann</creatorcontrib><creatorcontrib>WEILLER, Cornelius</creatorcontrib><creatorcontrib>HACKE, Werner</creatorcontrib><creatorcontrib>SCHELLINGER, Peter D</creatorcontrib><creatorcontrib>RÖTHER, Joachim</creatorcontrib><creatorcontrib>SOBESKY, Jan</creatorcontrib><creatorcontrib>BLUHMKI, Erich</creatorcontrib><creatorcontrib>FIEBACH, Jochen B</creatorcontrib><creatorcontrib>FIEHLER, Jens</creatorcontrib><creatorcontrib>WEBER, Olivier Zaro</creatorcontrib><creatorcontrib>KUCINSKI, Thomas</creatorcontrib><creatorcontrib>JUETTLER, Eric</creatorcontrib><creatorcontrib>RINGLEB, Peter A</creatorcontrib><creatorcontrib>MRI in Acute Stroke Study Group of the German Competence Network Stroke</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><collection>MEDLINE - Academic</collection><jtitle>Stroke (1970)</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>THOMALLA, Götz</au><au>SCHWARK, Christian</au><au>ZEUMER, Hermann</au><au>WEILLER, Cornelius</au><au>HACKE, Werner</au><au>SCHELLINGER, Peter D</au><au>RÖTHER, Joachim</au><au>SOBESKY, Jan</au><au>BLUHMKI, Erich</au><au>FIEBACH, Jochen B</au><au>FIEHLER, Jens</au><au>WEBER, Olivier Zaro</au><au>KUCINSKI, Thomas</au><au>JUETTLER, Eric</au><au>RINGLEB, Peter A</au><aucorp>MRI in Acute Stroke Study Group of the German Competence Network Stroke</aucorp><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Outcome and symptomatic bleeding complications of intravenous thrombolysis within 6 hours in MRI-selected Stroke patients: Comparison of a German multicenter Study with the pooled data of atlantis, ECASS, and ninds tPA trials</atitle><jtitle>Stroke (1970)</jtitle><addtitle>Stroke</addtitle><date>2006-03-01</date><risdate>2006</risdate><volume>37</volume><issue>3</issue><spage>852</spage><epage>858</epage><pages>852-858</pages><issn>0039-2499</issn><eissn>1524-4628</eissn><coden>SJCCA7</coden><abstract>We compared outcome and symptomatic bleeding complications of intravenous tissue plasminogen activator (IV-tPA) within 6 hours of symptom onset in MRI-selected patients with acute middle cerebral artery infarction with the pooled data of the large stroke tPA trials.
Patients were examined by perfusion-weighted and diffusion-weighted imaging < or =6 hours. Within 3 hours, patients were treated according to Second European-Australasian Acute Stroke Study (ECASS II) criteria. After 3 to 6 hours, treatment with IV-tPA was performed based on MRI findings. Favorable outcome was assessed after 90 days using a dichotomized modified Rankin scale score of 0 to 1. Intracerebral bleeding complications were assessed on follow-up MRI or computed tomography. Data were compared with the pooled placebo and pooled tPA patients of the ATLANTIS, ECASS, and National Institute of Neurological Disorders and Stroke (NINDS) tPA trials.
From 174 MRI-selected tPA patients, 62% (n=108) were treated in < or =3 hours and 38% (n=66) after 3 to 6 hours. Favorable outcome was more frequent in MRI-selected tPA patients (48% [95% CI, 39 to 54]) compared with pooled placebo (33% [95% CI, 31 to 36]; P<0.001) and pooled tPA patients (40% [95% CI, 37 to 42]; P=0.046). Odds ratios for favorable outcome in the MRI-selected tPA group were 1.82 (1.32 to 2.51) compared with the pooled placebo and 1.39 (1.01 to 1.92) compared with the pooled tPA group. The rate of symptomatic intracerebral hemorrhage in MRI-selected tPA patients (3% [95% CI, 0 to 5]) was lower than in the pooled tPA group (8% [95% CI, 7 to 10]; P=0.012) and comparable to the pooled placebo group (2% [95% CI, 1 to 3]; P=0.392).
This study supports that it is safe and effective to expand the time window for IV-tPA up to 6 hours in patients with tissue at risk as defined by MRI.</abstract><cop>Hagerstown, MD</cop><pub>Lippincott Williams & Wilkins</pub><pmid>16439696</pmid><doi>10.1161/01.STR.0000204120.79399.72</doi><tpages>7</tpages></addata></record> |
| fulltext | fulltext |
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| ispartof | Stroke (1970), 2006-03, Vol.37 (3), p.852-858 |
| issn | 0039-2499 1524-4628 |
| language | eng |
| recordid | cdi_proquest_miscellaneous_67701402 |
| source | MEDLINE; American Heart Association Journals; EZB-FREE-00999 freely available EZB journals; Alma/SFX Local Collection; Journals@Ovid Complete |
| subjects | Adolescent Adult Aged Aged, 80 and over Biological and medical sciences Blood. Blood coagulation. Reticuloendothelial system Cerebral Hemorrhage Clinical Trials as Topic Diffusion Magnetic Resonance Imaging - methods Female Germany Headache. Facial pains. Syncopes. Epilepsia. Intracranial hypertension. Brain oedema. Cerebral palsy Humans Infusions, Intravenous Magnetic Resonance Angiography - methods Magnetic Resonance Imaging - methods Male Medical sciences Middle Aged Nervous system (semeiology, syndromes) Neurology Odds Ratio Pharmacology. Drug treatments Placebos Stroke Thrombolytic Therapy - methods Time Factors Tissue Plasminogen Activator - administration & dosage Treatment Outcome Vascular diseases and vascular malformations of the nervous system |
| title | Outcome and symptomatic bleeding complications of intravenous thrombolysis within 6 hours in MRI-selected Stroke patients: Comparison of a German multicenter Study with the pooled data of atlantis, ECASS, and ninds tPA trials |
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