ASA: Intracranial Stent Safe In 'Real-World' Use

February 12, 2007

SAN FRANCISCO -- The intracranial Wingspan stent appears to be as safe for severe arterial stenosis in clinical practice as it was in the trials that led to its approval, researchers said here.

SAN FRANCISCO, Feb. 12 -- The intracranial Wingspan stent appears to be as safe for severe arterial stenosis in clinical practice as it was in the trials that led to its approval, researchers said here.

The 8.4% rate of 30-day stroke, intracranial hemorrhage, or death in a National Institutes of Health-sponsored registry compared favorably with the 9% rate reported in data submitted to the FDA, said Osama Zaidat, M.D., of the Medical College of Wisconsin in Milwaukee, at the American Stroke Association meeting.

But the NIH registry has so far only enrolled 131 patients, so findings need to be interpreted cautiously, Dr. Zaidat added. Moreover, the registry data fail to provide evidence that stenting offers any advantage over aspirin or Coumadin (warfarin).

Nonetheless, the registry offers the first glimpse of the real world safety and technical success of Wingspan, which is the only FDA-approved intracranial stent, noted Dr. Zaidat. All registry patients were symptomatic with 70% or more stenosis of an intracranial artery. Patients were treated at 16 participating centers.

The rate of stroke or death within 30 days or ipsilateral stroke beyond 30 days was slightly but insignificantly lower in the registry compared wth the Warfarin-Aspirin Symptomatic Intracranial Disease Trial (WASID ) trial (13.8%, 95% confidence interval 6.0% to 21.6%, versus 15.8%, 95% CI 10.4% to 23.7%).

"The study shows some potential benefit," he said, "but when you look at the confidence interval between the two groups you cannot rule out that stenting is superior to medical therapy or whether stenting is inferior to medical therapy."

"We think that a randomized trial comparing stenting in the head versus standard medical therapy is the way to go to answer this question," he added.

The patients in the registry with at least 70% stenosis were an average 64.2 years old and predominately white (78%). Their indication for stenting was stroke in 60% of cases followed by transient ischemic attack in 30% and an unspecified cerebral ischemic event in 10%. The mean pre-stent stenosis was 82% and 20% after stenting.