In a late-breaking abstract presented at the International Stroke Conference in Los Angeles, Feb 19-21, data from the WOVEN study (NCT04221984) suggest that brain stents are safe and effective for reducing the risk of recurrent stroke in people with intracranial atherosclerotic disease (ICAD). The WOVEN registry study is the largest intracranial stent trial for ICAD includes only stents approved by the Food and Drug Administration (FDA), and also includes long-term follow up.
The WOVEN trial is a registry of 150 individuals who had stents placed in intracranial vessels according to the FDA indication for using the wingspan stent. After 1 year, the risk of recurrent stroke or death was 8.7% compared with a typical rate of 20% recurrence or death.
“This trial is unique because prior studies included off-label patients. This is the largest intracranial stent trial for atherosclerotic disease performed according to the FDA indication for the wingspan stent,” said Michael J. Alexander, M.D., professor and vice chairman of neurosurgery at Cedars-Sinai Medical Center in Los Angeles. “The stroke and death rates were substantially lower than the 1-year rate of 20% in the stenting arm of the SAMMPRIS trial (NCT00576693) and slightly better than the 12.2% stroke and death rate in the medical arm of SAMMPRIS.”
“The long-term results of the WOVEN study are important to determine if safer stenting practices and lower complication rates from the treatment itself resulted in improved patient outcomes at one-year,” Alexander said. “Intracranial stenting could provide an alternative when medical therapy and other treatments have been unsuccessful.”
These results will likely lead to a randomized clinical trial comparing intracranial stenting to medical therapy alone.
A commentary from Mitchell S. V. Elkind, M.D., M.S., FAHA, FAAN, president elect of the American Heart Association, past chair of the Advisory Committee of the American Stroke Association—a division of the American Heart Association and professor of neurology and epidemiology at Columbia University New York and attending neurologist at Columbia University Medical Center of the New York-Presbyterian Hospital has also been made available.
Dr. Elkind noted, that although a previous study did not show any benefit of brain stents vs medical therapy, "(t)here's always been this residual question whether there is a subgroup of patients with intracranial stenosis who failed medical therapy, who despite all the best drugs and things that we throw at them, they still continue to have symptoms. And so, we all wonder whether among those patients, a highly selected group of patients, there's still a benefit to intracranial stenting. As we've seen in the realm of acute stroke therapy, with the transition from earlier endovascular therapies to the later stent retriever devices, it's possible that the subsequent technological developments will lead to a stent that really does help patients with intracranial stenosis."
Although these results are promising, they must be assessed with caution given that the trial is retrospective with a relatively small sample size. Prospective clinical trials comparing the wingspan stent with standard-of-care medical treatment is needed.
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