Source: DGNews  |  Posted 8 years ago

By Bruce Sylvester
Special to DG News

PHOENIX, AZ -- February 18, 2003 -- Stenting for vertebral and intracranial artery stenosis is successful, resulting in relatively low rates of stroke and symptomatic restenosis.

The findings of the Stenting of Symptomatic Atherosclerostic Lesions in the Vertebral or Intracranial Arteries (SSYLVIA) trial were presented here on February 15th at a late-breaking clinical trial session during the 28th International Stroke Conference.

"Not only did we find the stent to be highly implantable, but we also saw that it appeared to [prevent] stroke," said lead researcher Helmi Lutsep, MD, from the Oregon Health and Sciences University in Portland, United States.

Stroke rates reach 10% to 24% per year in patients with a symptomatic intracranial stenosis who are treated with medical therapies. Investigators designed this multicenter, non-randomized, prospective feasibility study to evaluate the NEUROLINK System for treatment of vertebral or intracranial artery stenosis.

Eligibility criteria were age 18 to 80 years, symptoms attributed to the target lesion, and a single target lesion that produced 50% or greater stenosis.

The 61 enrolled subjects underwent neurologic examinations at baseline and at intervals during the year after stent implantation. The primary end points were death or stroke within 30 days of implant surgery, and successful stent placement resulting in less than 50% stenosis. The secondary end points included angiographic evaluation of the treated segment at 6 months and target lesion-related stroke at 12 months.

Surgeons inserted stents into 43 intracranial arteries (15 internal carotid, 5 middle cerebral, 1 posterior cerebral, 17 basilar, 5 vertebral) and 18 extracranial vertebral arteries. They achieved successful stent placement in 95% of cases.

During the first 30 days after surgery, 6.6% of patients developed strokes. No deaths occurred. At 6 months, stenosis of more than 50% recurred in 30% of 33 evaluated intracranial arteries and 50% of 16 vertebral arteries. Fifty percent of extracranial restenoses appeared in the vertebral ostium. Thirty-nine percent of recurrent stenoses were symptomatic, 28.6% of which appeared in the vertebral ostia.

Of 42 patients with 12 month follow-up, 7% developed strokes related to the target lesion more than 30 days after stenting; one patient who was not stented also suffered a stroke.

"Further trials of this stenting system are warranted and may lead to important developments in the treatment of symptomatic stenosis," said Dr. Lutsep.

The study was supported by the Guidant Corporation.

[Study Title: Stenting of Symptomatic Atherosclerotic Lesions in the Vertebral or Intracranial Arteries (Ssylvia): Study Results
Abstract 83A]