Medical management with interventional therapy versus medical management alone for unruptured brain arteriovenous malformations (ARUBA):Final follow-up of a multicentre, non-blinded, randomised controlled trial

BACKGROUND: In A Randomized trial of Unruptured Brain Arteriovenous malformations (ARUBA), randomisation was halted at a mean follow-up of 33·3 months after a prespecified interim analysis showed that medical management alone was superior to the combination of medical management and interventional therapy in preventing symptomatic stroke or death. We aimed to study whether these differences persisted through 5-years' follow-up. METHODS: ARUBA was a non-blinded, randomised trial done at 39 clinical centres in nine countries. Adults (age ≥18 years) diagnosed with an unruptured brain arteriovenou... Mehr ...

Verfasser: Mohr, Jay P
Overbey, Jessica R
Hartmann, Andreas
Kummer, Rüdiger von
Al-Shahi Salman, Rustam
Kim, Helen
van der Worp, H Bart
Parides, Michael K
Stefani, Marco A
Houdart, Emmanuel
Libman, Richard
Pile-Spellman, John
Harkness, Kirsty
Cordonnier, Charlotte
Moquete, Ellen
Biondi, Alessandra
Klijn, Catharina J M
Stapf, Christian
Moskowitz, Alan J
Dokumenttyp: Artikel
Erscheinungsdatum: 2020
Reihe/Periodikum: Mohr , J P , Overbey , J R , Hartmann , A , Kummer , R V , Al-Shahi Salman , R , Kim , H , van der Worp , H B , Parides , M K , Stefani , M A , Houdart , E , Libman , R , Pile-Spellman , J , Harkness , K , Cordonnier , C , Moquete , E , Biondi , A , Klijn , C J M , Stapf , C , Moskowitz , A J & ARUBA co-investigators 2020 , ' Medical management with interventional therapy versus medical management alone for unruptured brain arteriovenous malformations (ARUBA) : Final follow-up of a multicentre, non-blinded, randomised controlled trial ' , Lancet Neurology , vol. 19 , no. 7 , pp. 573-581 . https://doi.org/10.1016/S1474-4422(20)30181-2
Schlagwörter: Adult / Arteriovenous Fistula/drug therapy / Embolization / Therapeutic/methods / Female / Follow-Up Studies / Humans / Intracranial Arteriovenous Malformations/drug therapy / Male / Middle Aged / Neurosurgical Procedures/methods / Radiosurgery/methods / Stroke/epidemiology / Treatment Outcome
Sprache: Englisch
Permalink: https://search.fid-benelux.de/Record/base-28867173
Datenquelle: BASE; Originalkatalog
Powered By: BASE
Link(s) : https://hdl.handle.net/11370/2953e3d4-2077-4701-a874-90db0db2b687

BACKGROUND: In A Randomized trial of Unruptured Brain Arteriovenous malformations (ARUBA), randomisation was halted at a mean follow-up of 33·3 months after a prespecified interim analysis showed that medical management alone was superior to the combination of medical management and interventional therapy in preventing symptomatic stroke or death. We aimed to study whether these differences persisted through 5-years' follow-up. METHODS: ARUBA was a non-blinded, randomised trial done at 39 clinical centres in nine countries. Adults (age ≥18 years) diagnosed with an unruptured brain arteriovenous malformation, who had never undergone interventional therapy, and were considered by participating clinical centres to be suitable for intervention to eradicate the lesion, were eligible for inclusion. Patients were randomly assigned (1:1) by a web-based data collection system, stratified by clinical centre in a random permuted block design with block sizes of two, four, and six, to medical management alone or with interventional therapy (neurosurgery, embolisation, or stereotactic radiotherapy, alone or in any combination, sequence, or number). Although patients and investigators at a given centre were not masked to treatment assignment, investigators at other centres and those in the clinical coordinating centre were not informed of assignment or outcomes at any of the centres. The primary outcome was time to death or symptomatic stroke confirmed by imaging, assessed by a neurologist at each centre not involved in the management of participants' care, and monitored by an independent committee using an adaptive approach with interim analyses. Enrolment began on April 4, 2007, and was halted on April 15, 2013, after which follow-up continued until July 15, 2015. All analyses were by intention to treat. This trial is registered with ClinicalTrials.gov, NCT00389181. FINDINGS: Of 1740 patients screened, 226 were randomly assigned to medical management alone (n=110) or medical management plus interventional therapy (n=116). ...