Background: Balloon dilatation and deployment of a self-expanding stent is a safe treatment for intracranial atherosclerotic stenoses. The significant recurrence rate might be related to the high radial force of the Wingspan stent.
Objective: To evaluate the procedural safety and stenosis recurrence rate by the use of a stent with reduced radial force (Enterprise).
Methods: Two hundred nine atherosclerotic stenoses (189 patients) were treated (median age, 68 years; 132 male) in a single center. Lesion locations included internal carotid artery (n = 27), middle cerebral artery (n = 62), vertebral artery (n = 64), basilar artery (n = 55), and posterior cerebral artery (n = 1). Pre- and postmedication included acetylsalicylic acid and Clopidogrel for at least 12 months. Preprocedural and follow-up examinations included magnetic resonance imaging (MRI), neurological assessment, and digital subtraction angiography (6, 12, 26, and 52 weeks). Data registry included age, sex, normal vessel diameter, degree of stenosis, residual stenosis after stent, minimal in-stent diameter, and occurrence of ischemic symptoms during follow-up.
Results: Median pre- and postprocedural stenosis rate was 65.4 ± 1% vs 25.1 ± 1%. Technical success rate was 100%. Major procedural complications occurred in 16 patients (8.1%). Combined neurological morbidity and mortality rate at 30 days was 2 patients (0.9%). In 174 stenoses (83%) angiographic follow-up was obtained (mean, 10.2 months). A restenosis (>50%) was observed in 43 (24.7%) cases after 4.2 months (mean) with 4 (9.3%) symptomatic lesions. Incidence of recurrent ischemia related to the stented artery was 2.2% during 10.2 months of mean follow-up.
Conclusion: Undersized balloon angioplasty and deployment of an Enterprise stent is safe and effective for intracranial stenoses. Follow-up results were equal to or better than those reported for bare-metal balloon-expandable or self-expanding stents and yielded excellent protection from recurrent ischemia.