Overall, despite limitations in design, endovascular technologies,
and suboptimal study populations, these reviewed trials provide
essential data in the continued refinement of endovascular therapy
for large-vessel ischemic stroke. We strongly support further high-
quality prospective investigations. In the interim, current data
strongly support the reasonable offering of endovascular therapy for
patients with LVO.
Disclosures
Dr Mocco serves a consultant for Endeavor Endovascular and Lazarus Effect. He is
an investor in Blockade Medical. Dr Khalessi serves on Clinical Events Committees
and provides physician device training for Stryker Neurovascular and Covidien-ev3.
These are minor financial conflicts by CNS guidelines. Dr Khalessi further serves on
the AHA Writing Group for Extended Use of iv-tPA on behalf of the AANS and the
National Steering Committee for Stroke Outcomes for the University Healthcare
Consortium (UHC). These Committee assignments are potential related fiduciary
but not financial conflicts. The other authors have no personal, financial, or
institutional interest in any of the drugs, materials, or devices described in this article.
Alexander A. Khalessi
San Diego, California
Kyle M. Fargen
Gainesville, Florida
Sean Lavine
New York, New York
J. Mocco
Nashville, Tennessee
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Preliminary Results of the ARUBA Study
Arteriovenous malformations (AVMs) are congenital lesions that,
when left untreated, portend a lifelong cumulative risk of stroke and
death. The fact that eradicating an AVM to eliminate its natural risk
comes at a price to the patient is not news and does not warrant
investigation. What is worthy of scrutiny is the need to value and
scale this induced morbidity in the light of the gain achieved, ie: a life
with long lasting cure. ARUBA tells us what we already know: there is
an initial price attached to the intervention. It does not tell us whether
the price is too high for any specific AVM. Yet, in spite of the grave
methodological shortcomings of the trial that highly bias its results
from the outset against intervention, intervention still emerged
a superior option for the Spetzler-Martin Grade 1 AVM. The
message is clear. There never was clinical equipoise to justify
randomizing grade 1, and almost certainly grade 2 patients. Equally,
there never was equipoise for the enrolled grade 4 patients, who
should be, by and large, left untreated. A registry of at least all
unselected grade 3 patients is what is needed to evoke meaningful
data that can preserve external validity.
On May 10, 2013, the National Institute of Neurological Disorders
and Stroke (NINDS) announced that A Randomized Trial of
Unruptured Brain AVMs study (ARUBA) had prematurely stopped
enrollment—a result of the pre-planned interim analysis performed
by the trial’s independent Data and Safety Monitoring Board
(DSMB), which demonstrated an event rate three times higher in the
intervention group than in the medical management group.
1
ARUBA was a randomized, multi-center trial comparing “best
possible AVM eradication” with non-invasive, medical management
to the primary endpoint, a composite of symptomatic stroke or
death. Methods to eradicate brain arteriovenous malformations
(BAVM) included radiosurgery, microsurgical resection, and endo-
vascular embolization, alone or in combination. The secondary
outcome measure was disability as measured by the Rankin Score at
5 years post-randomization. The initial study design had called for
enrollment of 800 patients, but this number was later reduced to 400
CORRESPONDENCE
NEUROSURGERY VOLUME 73 | NUMBER 2 | AUGUST 2013 | E379
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