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Updates in arteriovenous malformation management: the post-ARUBA era.

ABSTRACT: Brain arteriovenous malformations (AVMs) are complex and heterogeneous lesions that can rupture, causing significant morbidity and mortality. While ruptured lesions are usually treated, the management of unruptured AVMs remains unclear. A Randomized trial of Unruptured Brain Arteriovenous Malformations (ARUBA) was the first trial conducted to compare the effects of medical and interventional therapy. Although it concluded that medical therapy was superior in preventing stroke and death over a follow-up period of 33 months, the findings were met with intense criticism regarding several aspects of study design, progression, and analysis/conclusion. Namely, the increased use of stand-alone embolisation relative to microsurgery in a cohort with predominantly low-grade lesions combined with a short follow-up period amplified treatment risk. Subsequently, several observational studies were conducted on ARUBA-eligible patients to investigate the safety and efficacy of microsurgery, radiosurgery, and endovascular embolisation over longer follow-up periods. These reports showed that favourable safety profiles and cure rates can be achieved with appropriate patient selection and judicious use of different treatment modalities in multidisciplinary centres. Since large prospective randomised trials on AVMs may not be feasible, it is important to make use of practice-based data beyond the flawed ARUBA study to optimise patients' lifetime outcomes.

SUBMITTER: Feghali J

PROVIDER: S-EPMC7213498 | biostudies-literature | 2020

REPOSITORIES: biostudies-literature

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Updates in arteriovenous malformation management: the post-ARUBA era.

Feghali James J Huang Judy J

Stroke and vascular neurology 20190921 1

Brain arteriovenous malformations (AVMs) are complex and heterogeneous lesions that can rupture, causing significant morbidity and mortality. While ruptured lesions are usually treated, the management of unruptured AVMs remains unclear. A Randomized trial of Unruptured Brain Arteriovenous Malformations (ARUBA) was the first trial conducted to compare the effects of medical and interventional therapy. Although it concluded that medical therapy was superior in preventing stroke and death over a fo ...[more]

PMID: 32411406

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Project description: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.

Project description:BACKGROUND:Pulmonary arteriovenous malformations are abnormal direct connections between the pulmonary artery and pulmonary vein which result in a right-to-left shunt. They are associated with substantial morbidity and mortality mainly from the effects of paradoxical emboli. Potential complications include stroke, cerebral abscess, pulmonary haemorrhage and hypoxaemia. Embolisation is an endovascular intervention based on the occlusion of the feeding arteries the pulmonary arteriovenous malformations thus eliminating the abnormal right-to-left-shunting. This is an update of a previously published review. OBJECTIVES:To determine the efficacy and safety of embolisation in patients with pulmonary arteriovenous malformations including a comparison with surgical resection and different embolisation devices. SEARCH METHODS:We searched the Cystic Fibrosis and Genetic Disorders Group's Trials Register; date of last search: 10 April 2017.We also searched the following databases: the Australian New Zealand Clinical Trials Registry; ClinicalTrials.gov; International Standard Randomised Controlled Trial Number Register; International Clinical Trials Registry Platform Search Portal (last searched 27 August 2017). to be updatedWe checked cross-references and searched references from review articles. SELECTION CRITERIA:Trials in which individuals with pulmonary arteriovenous malformations were randomly allocated to embolisation compared to no treatment, surgical resection or embolisation using a different embolisation device. DATA COLLECTION AND ANALYSIS:Studies identified for potential inclusion were independently assessed for eligibility by two authors, with excluded studies further checked by a third author. No trials were identified for inclusion in the review and hence no analysis was performed. MAIN RESULTS:There were no randomised controlled trials included in the review; one ongoing trial has been identified which may be eligible for inclusion in the future. AUTHORS' CONCLUSIONS:There is no evidence from randomised controlled trials for embolisation of pulmonary arteriovenous malformations. However, randomised controlled trials are not always feasible on ethical grounds. Accumulated data from observational studies suggest that embolisation is a safe procedure which reduces morbidity and mortality. A standardised approach to reporting with long-term follow-up through registry studies can help to strengthen the evidence for embolisation in the absence of randomised controlled trials.

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Updates in arteriovenous malformation management: the post-ARUBA era.

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Updates in arteriovenous malformation management: the post-ARUBA era.

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