Medical management with or without interventional therapy for unruptured brain arteriovenous malformations (ARUBA): a multicentre, non-blinded, randomised trial
Summary Background The clinical benefit of preventive eradication of unruptured brain arteriovenous malformations remains uncertain. A Randomised trial of Unruptured Brain Arteriovenous malformations (ARUBA) aims to compare the risk of death and symptomatic stroke in patients with an unruptured brai...
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| Veröffentlicht in: | The Lancet (British edition) 2014-02, Vol.383 (9917), p.614-621 |
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| creator | Mohr, J P, Prof Parides, Michael K, Prof Stapf, Christian, Prof Moquete, Ellen, RN Moy, Claudia S, PhD Overbey, Jessica R, MS Salman, Rustam Al-Shahi, Prof Vicaut, Eric, Prof Young, William L, Prof Houdart, Emmanuel, Prof Cordonnier, Charlotte, Prof Stefani, Marco A, Prof Hartmann, Andreas, MD von Kummer, Rüdiger, Prof Biondi, Alessandra, Prof Berkefeld, Joachim, Prof Klijn, Catharina J M, MD Harkness, Kirsty, MD Libman, Richard, MD Barreau, Xavier, MD Moskowitz, Alan J, Prof |
| description | Summary Background The clinical benefit of preventive eradication of unruptured brain arteriovenous malformations remains uncertain. A Randomised trial of Unruptured Brain Arteriovenous malformations (ARUBA) aims to compare the risk of death and symptomatic stroke in patients with an unruptured brain arteriovenous malformation who are allocated to either medical management alone or medical management with interventional therapy. Methods Adult patients (≥18 years) with an unruptured brain arteriovenous malformation were enrolled into this trial at 39 clinical sites in nine countries. Patients were randomised (by web-based system, in a 1:1 ratio, with random permuted block design [block size 2, 4, or 6], stratified by clinical site) to medical management with interventional therapy (ie, neurosurgery, embolisation, or stereotactic radiotherapy, alone or in combination) or medical management alone (ie, pharmacological therapy for neurological symptoms as needed). Patients, clinicians, and investigators are aware of treatment assignment. The primary outcome is time to the composite endpoint of death or symptomatic stroke; the primary analysis is by intention to treat. This trial is registered with ClinicalTrials.gov , number NCT00389181. Findings Randomisation was started on April 4, 2007, and was stopped on April 15, 2013, when a data and safety monitoring board appointed by the National Institute of Neurological Disorders and Stroke of the National Institutes of Health recommended halting randomisation because of superiority of the medical management group (log-rank Z statistic of 4·10, exceeding the prespecified stopping boundary value of 2·87). At this point, outcome data were available for 223 patients (mean follow-up 33·3 months [SD 19·7]), 114 assigned to interventional therapy and 109 to medical management. The primary endpoint had been reached by 11 (10·1%) patients in the medical management group compared with 35 (30·7%) in the interventional therapy group. The risk of death or stroke was significantly lower in the medical management group than in the interventional therapy group (hazard ratio 0·27, 95% CI 0·14–0·54). No harms were identified, other than a higher number of strokes (45 vs 12, p |
| doi_str_mv | 10.1016/S0140-6736(13)62302-8 |
| format | Article |
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A Randomised trial of Unruptured Brain Arteriovenous malformations (ARUBA) aims to compare the risk of death and symptomatic stroke in patients with an unruptured brain arteriovenous malformation who are allocated to either medical management alone or medical management with interventional therapy. Methods Adult patients (≥18 years) with an unruptured brain arteriovenous malformation were enrolled into this trial at 39 clinical sites in nine countries. Patients were randomised (by web-based system, in a 1:1 ratio, with random permuted block design [block size 2, 4, or 6], stratified by clinical site) to medical management with interventional therapy (ie, neurosurgery, embolisation, or stereotactic radiotherapy, alone or in combination) or medical management alone (ie, pharmacological therapy for neurological symptoms as needed). Patients, clinicians, and investigators are aware of treatment assignment. The primary outcome is time to the composite endpoint of death or symptomatic stroke; the primary analysis is by intention to treat. This trial is registered with ClinicalTrials.gov , number NCT00389181. Findings Randomisation was started on April 4, 2007, and was stopped on April 15, 2013, when a data and safety monitoring board appointed by the National Institute of Neurological Disorders and Stroke of the National Institutes of Health recommended halting randomisation because of superiority of the medical management group (log-rank Z statistic of 4·10, exceeding the prespecified stopping boundary value of 2·87). At this point, outcome data were available for 223 patients (mean follow-up 33·3 months [SD 19·7]), 114 assigned to interventional therapy and 109 to medical management. The primary endpoint had been reached by 11 (10·1%) patients in the medical management group compared with 35 (30·7%) in the interventional therapy group. The risk of death or stroke was significantly lower in the medical management group than in the interventional therapy group (hazard ratio 0·27, 95% CI 0·14–0·54). No harms were identified, other than a higher number of strokes (45 vs 12, p<0·0001) and neurological deficits unrelated to stroke (14 vs 1, p=0·0008) in patients allocated to interventional therapy compared with medical management. Interpretation The ARUBA trial showed that medical management alone is superior to medical management with interventional therapy for the prevention of death or stroke in patients with unruptured brain arteriovenous malformations followed up for 33 months. The trial is continuing its observational phase to establish whether the disparities will persist over an additional 5 years of follow-up. Funding National Institutes of Health, National Institute of Neurological Disorders and Stroke.</description><identifier>ISSN: 0140-6736</identifier><identifier>EISSN: 1474-547X</identifier><identifier>DOI: 10.1016/S0140-6736(13)62302-8</identifier><identifier>PMID: 24268105</identifier><identifier>CODEN: LANCAO</identifier><language>eng</language><publisher>Kidlington: Elsevier Ltd</publisher><subject>Adult ; Aged ; Biological and medical sciences ; Brain ; Brain research ; Catheters ; Cause of Death ; Children & youth ; Combined Modality Therapy ; Embolization, Therapeutic - methods ; Female ; General aspects ; Humans ; Internal Medicine ; Intracranial Arteriovenous Malformations - drug therapy ; Intracranial Arteriovenous Malformations - radiotherapy ; Intracranial Arteriovenous Malformations - surgery ; Male ; Medical imaging ; Medical sciences ; Middle Aged ; Mortality ; Neurology ; Neurosurgical Procedures - methods ; Patients ; Prospective Studies ; Radiation therapy ; Radiosurgery - methods ; Stroke - prevention & control ; Treatment Outcome ; Vascular diseases and vascular malformations of the nervous system ; Young Adult</subject><ispartof>The Lancet (British edition), 2014-02, Vol.383 (9917), p.614-621</ispartof><rights>Elsevier Ltd</rights><rights>2014 Elsevier Ltd</rights><rights>2015 INIST-CNRS</rights><rights>Copyright © 2014 Elsevier Ltd. All rights reserved.</rights><rights>Copyright Elsevier Limited Feb 15, 2014</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c665t-7365eea6405754147583838fdeeab9c8b69406b1498cccfaa60ec21c424e92db3</citedby><cites>FETCH-LOGICAL-c665t-7365eea6405754147583838fdeeab9c8b69406b1498cccfaa60ec21c424e92db3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://www.sciencedirect.com/science/article/pii/S0140673613623028$$EHTML$$P50$$Gelsevier$$H</linktohtml><link.rule.ids>230,314,776,780,881,3537,27901,27902,65534</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=28175163$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/24268105$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Mohr, J P, Prof</creatorcontrib><creatorcontrib>Parides, Michael K, Prof</creatorcontrib><creatorcontrib>Stapf, Christian, Prof</creatorcontrib><creatorcontrib>Moquete, Ellen, RN</creatorcontrib><creatorcontrib>Moy, Claudia S, PhD</creatorcontrib><creatorcontrib>Overbey, Jessica R, MS</creatorcontrib><creatorcontrib>Salman, Rustam Al-Shahi, Prof</creatorcontrib><creatorcontrib>Vicaut, Eric, Prof</creatorcontrib><creatorcontrib>Young, William L, Prof</creatorcontrib><creatorcontrib>Houdart, Emmanuel, Prof</creatorcontrib><creatorcontrib>Cordonnier, Charlotte, Prof</creatorcontrib><creatorcontrib>Stefani, Marco A, Prof</creatorcontrib><creatorcontrib>Hartmann, Andreas, MD</creatorcontrib><creatorcontrib>von Kummer, Rüdiger, Prof</creatorcontrib><creatorcontrib>Biondi, Alessandra, Prof</creatorcontrib><creatorcontrib>Berkefeld, Joachim, Prof</creatorcontrib><creatorcontrib>Klijn, Catharina J M, MD</creatorcontrib><creatorcontrib>Harkness, Kirsty, MD</creatorcontrib><creatorcontrib>Libman, Richard, MD</creatorcontrib><creatorcontrib>Barreau, Xavier, MD</creatorcontrib><creatorcontrib>Moskowitz, Alan J, Prof</creatorcontrib><creatorcontrib>for the international ARUBA investigators</creatorcontrib><creatorcontrib>international ARUBA investigators</creatorcontrib><title>Medical management with or without interventional therapy for unruptured brain arteriovenous malformations (ARUBA): a multicentre, non-blinded, randomised trial</title><title>The Lancet (British edition)</title><addtitle>Lancet</addtitle><description>Summary Background The clinical benefit of preventive eradication of unruptured brain arteriovenous malformations remains uncertain. A Randomised trial of Unruptured Brain Arteriovenous malformations (ARUBA) aims to compare the risk of death and symptomatic stroke in patients with an unruptured brain arteriovenous malformation who are allocated to either medical management alone or medical management with interventional therapy. Methods Adult patients (≥18 years) with an unruptured brain arteriovenous malformation were enrolled into this trial at 39 clinical sites in nine countries. Patients were randomised (by web-based system, in a 1:1 ratio, with random permuted block design [block size 2, 4, or 6], stratified by clinical site) to medical management with interventional therapy (ie, neurosurgery, embolisation, or stereotactic radiotherapy, alone or in combination) or medical management alone (ie, pharmacological therapy for neurological symptoms as needed). Patients, clinicians, and investigators are aware of treatment assignment. The primary outcome is time to the composite endpoint of death or symptomatic stroke; the primary analysis is by intention to treat. This trial is registered with ClinicalTrials.gov , number NCT00389181. Findings Randomisation was started on April 4, 2007, and was stopped on April 15, 2013, when a data and safety monitoring board appointed by the National Institute of Neurological Disorders and Stroke of the National Institutes of Health recommended halting randomisation because of superiority of the medical management group (log-rank Z statistic of 4·10, exceeding the prespecified stopping boundary value of 2·87). At this point, outcome data were available for 223 patients (mean follow-up 33·3 months [SD 19·7]), 114 assigned to interventional therapy and 109 to medical management. The primary endpoint had been reached by 11 (10·1%) patients in the medical management group compared with 35 (30·7%) in the interventional therapy group. The risk of death or stroke was significantly lower in the medical management group than in the interventional therapy group (hazard ratio 0·27, 95% CI 0·14–0·54). No harms were identified, other than a higher number of strokes (45 vs 12, p<0·0001) and neurological deficits unrelated to stroke (14 vs 1, p=0·0008) in patients allocated to interventional therapy compared with medical management. Interpretation The ARUBA trial showed that medical management alone is superior to medical management with interventional therapy for the prevention of death or stroke in patients with unruptured brain arteriovenous malformations followed up for 33 months. The trial is continuing its observational phase to establish whether the disparities will persist over an additional 5 years of follow-up. Funding National Institutes of Health, National Institute of Neurological Disorders and Stroke.</description><subject>Adult</subject><subject>Aged</subject><subject>Biological and medical sciences</subject><subject>Brain</subject><subject>Brain research</subject><subject>Catheters</subject><subject>Cause of Death</subject><subject>Children & youth</subject><subject>Combined Modality Therapy</subject><subject>Embolization, Therapeutic - methods</subject><subject>Female</subject><subject>General aspects</subject><subject>Humans</subject><subject>Internal Medicine</subject><subject>Intracranial Arteriovenous Malformations - drug therapy</subject><subject>Intracranial Arteriovenous Malformations - radiotherapy</subject><subject>Intracranial Arteriovenous Malformations - surgery</subject><subject>Male</subject><subject>Medical imaging</subject><subject>Medical sciences</subject><subject>Middle Aged</subject><subject>Mortality</subject><subject>Neurology</subject><subject>Neurosurgical Procedures - methods</subject><subject>Patients</subject><subject>Prospective Studies</subject><subject>Radiation therapy</subject><subject>Radiosurgery - methods</subject><subject>Stroke - prevention & control</subject><subject>Treatment Outcome</subject><subject>Vascular diseases and vascular malformations of the nervous system</subject><subject>Young 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management with or without interventional therapy for unruptured brain arteriovenous malformations (ARUBA): a multicentre, non-blinded, randomised trial</title><author>Mohr, J P, Prof ; Parides, Michael K, Prof ; Stapf, Christian, Prof ; Moquete, Ellen, RN ; Moy, Claudia S, PhD ; Overbey, Jessica R, MS ; Salman, Rustam Al-Shahi, Prof ; Vicaut, Eric, Prof ; Young, William L, Prof ; Houdart, Emmanuel, Prof ; Cordonnier, Charlotte, Prof ; Stefani, Marco A, Prof ; Hartmann, Andreas, MD ; von Kummer, Rüdiger, Prof ; Biondi, Alessandra, Prof ; Berkefeld, Joachim, Prof ; Klijn, Catharina J M, MD ; Harkness, Kirsty, MD ; Libman, Richard, MD ; Barreau, Xavier, MD ; Moskowitz, Alan J, 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Aged</topic><topic>Mortality</topic><topic>Neurology</topic><topic>Neurosurgical Procedures - methods</topic><topic>Patients</topic><topic>Prospective Studies</topic><topic>Radiation therapy</topic><topic>Radiosurgery - methods</topic><topic>Stroke - prevention & control</topic><topic>Treatment Outcome</topic><topic>Vascular diseases and vascular malformations of the nervous system</topic><topic>Young Adult</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Mohr, J P, Prof</creatorcontrib><creatorcontrib>Parides, Michael K, Prof</creatorcontrib><creatorcontrib>Stapf, Christian, Prof</creatorcontrib><creatorcontrib>Moquete, Ellen, RN</creatorcontrib><creatorcontrib>Moy, Claudia S, PhD</creatorcontrib><creatorcontrib>Overbey, Jessica R, MS</creatorcontrib><creatorcontrib>Salman, Rustam Al-Shahi, Prof</creatorcontrib><creatorcontrib>Vicaut, Eric, Prof</creatorcontrib><creatorcontrib>Young, William L, Prof</creatorcontrib><creatorcontrib>Houdart, 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Database (Alumni Edition)</collection><collection>ProQuest Newsstand Professional</collection><collection>ProQuest Biological Science Collection</collection><collection>Consumer Health Database</collection><collection>Health & 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 & Allied Health Premium</collection><collection>ProQuest Central (New)</collection><collection>ProQuest One Academic (New)</collection><collection>ProQuest Health & Medical Research Collection</collection><collection>ProQuest One Academic Middle East (New)</collection><collection>ProQuest One Health & Nursing</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Applied & Life Sciences</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><collection>PubMed Central (Full Participant titles)</collection><jtitle>The Lancet (British edition)</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Mohr, J P, Prof</au><au>Parides, Michael K, Prof</au><au>Stapf, Christian, Prof</au><au>Moquete, Ellen, RN</au><au>Moy, Claudia S, PhD</au><au>Overbey, Jessica R, MS</au><au>Salman, Rustam Al-Shahi, Prof</au><au>Vicaut, Eric, Prof</au><au>Young, William L, Prof</au><au>Houdart, Emmanuel, Prof</au><au>Cordonnier, Charlotte, Prof</au><au>Stefani, Marco A, Prof</au><au>Hartmann, Andreas, MD</au><au>von Kummer, Rüdiger, Prof</au><au>Biondi, Alessandra, Prof</au><au>Berkefeld, Joachim, Prof</au><au>Klijn, Catharina J M, MD</au><au>Harkness, Kirsty, MD</au><au>Libman, Richard, MD</au><au>Barreau, Xavier, MD</au><au>Moskowitz, Alan J, Prof</au><aucorp>for the international ARUBA investigators</aucorp><aucorp>international ARUBA investigators</aucorp><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Medical management with or without interventional therapy for unruptured brain arteriovenous malformations (ARUBA): a multicentre, non-blinded, randomised trial</atitle><jtitle>The Lancet (British edition)</jtitle><addtitle>Lancet</addtitle><date>2014-02-15</date><risdate>2014</risdate><volume>383</volume><issue>9917</issue><spage>614</spage><epage>621</epage><pages>614-621</pages><issn>0140-6736</issn><eissn>1474-547X</eissn><coden>LANCAO</coden><abstract>Summary Background The clinical benefit of preventive eradication of unruptured brain arteriovenous malformations remains uncertain. A Randomised trial of Unruptured Brain Arteriovenous malformations (ARUBA) aims to compare the risk of death and symptomatic stroke in patients with an unruptured brain arteriovenous malformation who are allocated to either medical management alone or medical management with interventional therapy. Methods Adult patients (≥18 years) with an unruptured brain arteriovenous malformation were enrolled into this trial at 39 clinical sites in nine countries. Patients were randomised (by web-based system, in a 1:1 ratio, with random permuted block design [block size 2, 4, or 6], stratified by clinical site) to medical management with interventional therapy (ie, neurosurgery, embolisation, or stereotactic radiotherapy, alone or in combination) or medical management alone (ie, pharmacological therapy for neurological symptoms as needed). Patients, clinicians, and investigators are aware of treatment assignment. The primary outcome is time to the composite endpoint of death or symptomatic stroke; the primary analysis is by intention to treat. This trial is registered with ClinicalTrials.gov , number NCT00389181. Findings Randomisation was started on April 4, 2007, and was stopped on April 15, 2013, when a data and safety monitoring board appointed by the National Institute of Neurological Disorders and Stroke of the National Institutes of Health recommended halting randomisation because of superiority of the medical management group (log-rank Z statistic of 4·10, exceeding the prespecified stopping boundary value of 2·87). At this point, outcome data were available for 223 patients (mean follow-up 33·3 months [SD 19·7]), 114 assigned to interventional therapy and 109 to medical management. The primary endpoint had been reached by 11 (10·1%) patients in the medical management group compared with 35 (30·7%) in the interventional therapy group. The risk of death or stroke was significantly lower in the medical management group than in the interventional therapy group (hazard ratio 0·27, 95% CI 0·14–0·54). No harms were identified, other than a higher number of strokes (45 vs 12, p<0·0001) and neurological deficits unrelated to stroke (14 vs 1, p=0·0008) in patients allocated to interventional therapy compared with medical management. Interpretation The ARUBA trial showed that medical management alone is superior to medical management with interventional therapy for the prevention of death or stroke in patients with unruptured brain arteriovenous malformations followed up for 33 months. The trial is continuing its observational phase to establish whether the disparities will persist over an additional 5 years of follow-up. Funding National Institutes of Health, National Institute of Neurological Disorders and Stroke.</abstract><cop>Kidlington</cop><pub>Elsevier Ltd</pub><pmid>24268105</pmid><doi>10.1016/S0140-6736(13)62302-8</doi><tpages>8</tpages><oa>free_for_read</oa></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 0140-6736 |
| ispartof | The Lancet (British edition), 2014-02, Vol.383 (9917), p.614-621 |
| issn | 0140-6736 1474-547X |
| language | eng |
| recordid | cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_4119885 |
| source | MEDLINE; Elsevier ScienceDirect Journals |
| subjects | Adult Aged Biological and medical sciences Brain Brain research Catheters Cause of Death Children & youth Combined Modality Therapy Embolization, Therapeutic - methods Female General aspects Humans Internal Medicine Intracranial Arteriovenous Malformations - drug therapy Intracranial Arteriovenous Malformations - radiotherapy Intracranial Arteriovenous Malformations - surgery Male Medical imaging Medical sciences Middle Aged Mortality Neurology Neurosurgical Procedures - methods Patients Prospective Studies Radiation therapy Radiosurgery - methods Stroke - prevention & control Treatment Outcome Vascular diseases and vascular malformations of the nervous system Young Adult |
| title | Medical management with or without interventional therapy for unruptured brain arteriovenous malformations (ARUBA): a multicentre, non-blinded, randomised trial |
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