Longer follow-up needed
In an editorial that accompanies the current study, Peter M. Rothwell, MD, of the University of Oxford, England, also dismisses much of the criticism of the ARUBA study. On the issue of external validity, he said: “I do not think that this is really any greater an issue for ARUBA than for most other similar trials.”
But Dr. Rothwell does believe that follow-up for longer than 5 years is needed. “To really understand the benefit/risk balance, we would need a 20- or 30-year follow-up. These patients are often in their 20s, 30s, or 40s, so we really need to know their cumulative risk over decades,” he said in an interview.
Noting that the study was funded by the National Institute of Neurological Disorders and Stroke (NINDS), Dr. Rothwell said funding should have been provided for much longer follow-up. “Patients who generously agreed to be randomly assigned in ARUBA and future similar patients have been let down by NINDS.
“We probably now won’t ever know the very–long-term impact, although the Scottish population study is following patients longer term,” he added.
“After this trial was first published, the guidelines recommended not to intervene. These latest results will not change that,” he said.
The ARUBA trial was funded internationally by the National Institutes of Health/NINDS. Dr. Stapf and Dr. Rothwell have disclosed no relevant financial relationships.
A version of this article originally appeared on Medscape.com.