If you have one of these you should have a long discussion with your doctor.
Lots of controversy.
Unruptured cerebral arteriovenous malformations are better off treated medically: the ARUBA trial
September 2017
Leading Cause of Stroke in Young Going Untreated – and It Shouldn’t, Study Finds - AVMs March 2016
The latest here:
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
- et al.
Published:July, 2020DOI:https://doi.org/10.1016/S1474-4422(20)30181-2
Summary
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). During a mean follow-up
of 50·4 months (SD 22·9), the incidence of death or symptomatic stroke was lower with
medical management alone (15 of 110, 3·39 per 100 patient-years) than with medical
management with interventional therapy (41 of 116, 12·32 per 100 patient-years; hazard
ratio 0·31, 95% CI 0·17 to 0·56). Two patients in the medical management group and
four in the interventional therapy group (two attributed to intervention) died during
follow-up. Adverse events were observed less often in patients allocated to medical
management compared with interventional therapy (283
vs 369; 58·97
vs 78·73 per 100 patient-years; risk difference −19·76, 95% CI −30·33 to −9·19).
Interpretation
After extended follow-up, ARUBA showed that medical management alone remained superior
to interventional therapy for the prevention of death or symptomatic stroke in patients
with an unruptured brain arteriovenous malformation. The data concerning the disparity
in outcomes should affect standard specialist practice and the information presented
to patients. The even longer-term risks and differences between the two therapeutic
approaches remains uncertain.
Funding
National Institute of Neurological Disorders and Stroke for the randomisation phase
and Vital Projects Fund for the follow-up phase.
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