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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.

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BACKGROUND AND PURPOSE: Report on the status of an on-going National Institutes of Neurological Disorders and Stroke (NINDS)-supported clinical trial of management of unbled brain arteriovenous malformations. SUMMARY OF REVIEW: Begun in April 2007 with 3 centers, the trial has grown to 65 centers, and has randomized 124 patients through mid-June 2010 en route to the planned 400. The current literature continues to support the rationale for the trial. CONCLUSIONS: ARUBA is steadily approaching its monthly randomization goals and has already reached the number needed to test the maximum published interventional complication rates against the minimum hemorrhage rates for natural history.

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Despite almost a century of efforts in the treatment of brain arteriovenous malformations (BAVMs) no clinical trial has yet been performed to demonstrate the benefits of intervention versus conservative (medical) management for those not yet bled. Only insufficient information on the natural history of unbled BAVMs exists to certify that intervention is needed and that such intervention produces a better long-term functional outcome.

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New treatments for acute stroke require a rapid triage system, which minimizes treatment delays and maximizes selection of eligible patients. Our aim was to create a score for assessing the probability of brain hemorrhage among patients with acute stroke based upon clinical information. Of 1805 patients in the Stroke Data Bank, 1273 had infarction (INF) and 237 had parenchymatous hemorrhage (HEM) verified by CT. INF and HEM discriminators were determined by logistic regression and used to create a score. ROC curve was used to choose the cut-point for predicting HEM (score

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New treatments for acute stroke require a rapid triage system, which minimizes treatment delays and maximizes selection of eligible patients. Our aim was to create a score for assessing the probability of brain hemorrhage among patients with acute stroke based upon clinical information. Of 1805 patients in the Stroke Data Bank, 1273 had infarction (INF) and 237 had parenchymatous hemorrhage (HEM) verified by CT. INF and HEM discriminators were determined by logistic regression and used to create a score. ROC curve was used to choose the cut-point for predicting HEM (score <= 2), with sensitivity of 76 percent and specificity of 83 percent. External validation was done using the NOMASS cohort. Although the use of a practical score by emergency personnel cannot replace the gold-standard brain image differentiation of HEM from INF for thrombolytic therapy, this score can help to select patients for stroke trials and pre-hospital treatments, alert CT scan technicians, and warn stroke teams of incoming patients to reduce treatment delays

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Recent advances in technology have improved stroke diagnosis, reduced the risks and increased the frequency of studies of stroke mechanism. Computer-assisted stroke data bank projects have provided new insights into the frequencies of stroke subtypes and the risks for progression and recurrence. A high frequency of strokes due to infarction remain unexplained despite thorough laboratory investigation. These infarcts of undetermined cause suffer recurrence rates almost as high as cardiogenic embolism, forcing a therapeutic decision even in the absence of a demonstrated cause. Stroke from atherosclerosis is far less common than formerly believed but carries the highest risk of worsening and early recurrence, prompting early treatment to attempt to avoid progression. Duplex and transcranial doppler methods of imaging blood vessels and insonating flow have now made it possible non-invasively to follow the course of atheromatous stenosis, embolism and recanalization, development of collateral flow, and vasospasm in ruptured aneurysms and arteriovenous malformations. Extracranial atheromatous disease may progress rapidly from mild to severe stenosis, stabilize at any point; intracranial collateral is not predicted by the degree of extracranial stenosis. Recanalization of cerebral embolism occurs early. Vasospasm after subarachnoid hemorrhage is common and often severe. Where available, magnetic resonance imaging is preferred to CT scanning for the diagnosis of every form of stroke including hemorrhage.

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