LOS ANGELES -- Intracranial stents safely reduce risk of recurrence is the finding of WOVEN trial which is one of the largest on-label, intracranial stenting trial to-date with long-term follow-up.
Intracranial stents are mesh tubes that act as permanent implants to open clogged brain arteries, which improve blood in flow to the brain.
Researchers have found that intracranial stent appears safe and effective for reducing the risk of recurrent stroke in patients with cholesterol-clogged brain arteries.The study was presented at the American Stroke Association's International Stroke Conference 2020.
A previous study, the WEAVE trial, showed a low 2.6% stroke and death rate within the first few days of the procedure in patients received the Wingspan stent for intracranial atherosclerotic disease. The current study yielded a long-term 8.5% total one-year stroke and death rate.
"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 one-year rate of 20% in the stenting arm of the SAMMPRIS trial and slightly better than the 12.2% stroke and death rate in the medical arm of SAMMPRIS."
The current study - Wingspan One-year Vascular Imaging, Events and Neurologic Outcomes, known as WOVEN - is the largest on-label, intracranial stenting trial to-date with long-term follow-up.
WOVEN - conducted at 16 U.S. centers - followed 152 patients who were treated with the self-expanding Wingspan stent from the WEAVE trial according to the FDA guidelines for use. Data on subsequent strokes and deaths were collected, and follow-up imaging assessed possible reclogging of the stent.
"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.
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