A brain stent appears safe and effective for reducing the risk of recurrent stroke in patients with cholesterol-clogged brain arteries, according to late-breaking data presented at the International Stroke Conference (ISC; 19–21 February, Los Angeles, USA).
Discussing the one-year results of the Woven study, Michael J Alexander, Cedars-Sinai Medical Center, Los Angeles, USA, told delegates: “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.”
He enthused that the trial is unique because prior studies only included off-label patients. “It is the largest intracranial stent trial for atherosclerotic disease performed according to the US FDA [Food and Drug Administration] indication for the Wingspan stent,” Alexander confirmed.
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 who received the Wingspan stent for intracranial atherosclerotic disease. The current study yielded a long-term 8.5% total one-year stroke and death rate.
According to Alexander, the Woven (Wingspan one-year vascular Imaging, events and neurologic outcomes) trial was conducted at 16 US centres. The investigators followed 152 patients who were treated with the Wingspan stent from the WEAVE trial, and subsequently collected data on strokes and deaths, while 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,” he added.
He concluded by suggesting that the current data will likely lead to a randomised clinical trial comparing intracranial stenting to medical therapy alone.