ARUBA Trail

Is anybody of us taking the ARUBA trail here ? May I please know your details.?


br
reza

Wife emailed to see about joining. She was told if you have had any AVM treatment, you were not eligible.

I don’t want to discourage anyone from participating, but I’d have to think long and hard about not treating an AVM if you and your dr thought it should be treated. Or maybe I don’t understand all they are wanting to do.

Best Wishes,
Ron, KS

The ARUBA trial randomly assigns patients with unruptured AVMs into treat or no-treat conditions. It is rather controversial in the neurosurgery world. The June 2008 issue of the academic research journal Neuroradiology published two short articles in tandem, one explaining the approach and presumed research benefits of the ARUBA trial, and the other arguing (pretty vehemently) against it. One cannot see these articles online without authentication and access through an academic library, but the publisher of the journal does allow anyone to see a preview page that shows the first page of each article.

Here is the page for the pro-ARUBA article (“ARUBA–beating natural history in unruptured brain AVMs by intervention”):
http://www.springerlink.com/content/h1526442886562h7/

Here is the page for the anti-ARUBA article (“Arguments against the proposed randomised trial [ARUBA]”):
http://www.springerlink.com/content/r176727n785788r1/

I will paste in here the conclusion of the anti-ARUBA article, which is written by a Swedish neurosurgeon who thinks the ARUBA trial is not just scientifically problematic, but also unethical. Here’s his conclusion:

The ARUBA study is as yet an example of how the road to
hell is paved with good intentions. The study is prospective
and randomized, but the inclusion criteria are too wide and
the primary endpoint irrelevant. It is maybe impossible to
design the 20- or 25-year study that would be necessary to
achieve the high goals of ARUBA. Still, the bottom line is
that ARUBA is a comparison of intervention or not during
the short 5-year follow-up, while the majority of untoward
events will occur later. The study is powered to compare
“any intervention” to no treatment; it is not designed to
study natural history or to compare different treatments.
Subsequently, any data collected in the study will be biased
by the study design and not readily applicable for other
analyses. It is scientifically and morally unsound to carry out a
poor study, when the desired study is impossible. In this
case it is better to refrain from the study altogether. That
would avoid the two major risks: the risk that a defective
study determines future AVM management and the risk that
patients with uncomplicated lesions who were randomized
to no treatment suffer hemorrhages long after the study is
finished.

Lastly, here is a link to a short commentary in the academic journal Stroke by a Pennsylvania neurosurgeon arguing that the ARUBA trial is unlikely to successfully achieve its scientific objectives:

http://stroke.ahajournals.org/cgi/content/full/38/12/3310

Here’s the key paragraph from that article:

Obviously, the above example does not account for the many variations in natural history and treatment risk known to exist related to both patient and AVM factors. The fact that such a plethora of potentially significant variables exists only serves to further complicate treatment decisions and makes the extrapolation of data from published trials to individual patients exceedingly difficult. Although the ARUBA study will endeavor to offer definitive resolution to this debate, it is unlikely that this goal will be attained. As designed, ARUBA is subject to many of the same methodological problems common to most prospective, randomized, controlled trial. Selection bias remains a major challenge and in a disease such as cerebral AVM with a long history of established treatment patterns, the randomization of an adequate representation of lesions with various risk profiles and multimodality treatment patterns will be difficult. Without such representation, the external validity of this trial is threatened. In addition, adequately controlling for all these covariates will likely render the study underpowered to detect a significant difference at only 5-years. Although the use of a 5-year end point is typical of prospective, randomized, controlled trials of this type, the relevance of such a short time period to clinical decision-making in a disease that may play out over 20-plus years is at best questionable. It is important to remember that 5 years of follow-up in 1000 patients is not the same as 20 years of follow-up in 250 patients, even though the number of patient-years is the same. Put another way, even the most aggressive neurosurgeon would be unlikely to treat a patient with an asymptomatic AVM, if the patient was known to have only a 5-year life expectancy. In the end, ARUBA will undoubtedly provide clinicians with new information, but the scope and applicability of this information will likely be much more limited than first anticipated.

This was more or less the view of my neurosurgeon when I inquired as to why his institution isn’t participating in the trial. My AVM was unruptured and asymptomatic – precisely the kind the ARUBA trial is intended for. When I sought a consult from Spetzler’s group at Barrow in Phoenix they invited me to join the trial but I declined, preferring to decide for myself on intervention rather than yield to random assignment to treat or no-treat.

1 Like

Wow, this proved to be prophetic. I'm glad I found this post, as it confirmed my feelings about this particular study.

I thought the ARUBA study was discontinued? No? In any case BB provided some very good information on the questions and potential risks of the study. Thank you BB.

This is a discussion from 2010, but it foretold all the problems inherent in the study. I just found it interesting.