Stenting of Symptomatic Atherosclerotic Lesions in the Vertebral or Intracranial Arteries (SSYLVIA): Study results

Background and Purpose-Stroke rates in patients with symptomatic intracranial stenosis may be as high as 10% to 24% per year on medical therapy. This multicenter, nonrandomized, prospective feasibility study evaluated the NEUROLINK System for treatment of vertebral or intracranial artery stenosis. Methods-Patients were 18 to 80 years old with symptoms attributed to a single target lesion of ≥50% stenosis. Patients received 5 neurological examinations before and in the year after the procedure, and another angiogram at 6 months. Results-In 61 patients enrolled, 43 (70.5%) intracranial arteries (15 internal carotid, 5 middle cerebral, 1 posterior cerebral, 17 basilar, 5 vertebral) and 18 (29.5%) extracranial vertebral arteries (6 ostia, 12 proximal to the posterior inferior cerebellar artery [PICA]) were treated. In the first 30 days, 4 patients (6.6%) had strokes and no deaths occurred. Successful stent placement was achieved in 58/61 cases (95%). At 6 months, stenosis of ≥50% occurred in 12/37 (32.4%) intracranial arteries and 6/14 (42.9%) extracranial vertebrals, 4 in the vertebral ostia. Seven (39%) recurrent stenoses were symptomatic. Four of 55 patients (7.3%) had strokes later than 30 days, 1 of which was in the only patient not stented. Conclusions-The NEUROLINK System is associated with a high rate of successful stent deployment. Strokes occurred in 6.6% of patients within 30 days and in 7.3% between 30 days and 1 year. Although restenoses occurred in 35% of patients, 61% were asymptomatic. Further trials involving the NEUROLINK System are warranted.