Background and purpose: A recent trial shows an 8.3 per 100-patient-years' ischemic stroke rate in the territory of the intracranial stenotic artery, despite aspirin treatment. Our aim was to prospectively study the feasibility and outcome of a new intracranial balloon-expandable Apollo stent for symptomatic atherosclerotic intracranial stenosis (SAIS).
Materials and methods: Forty-six patients (41 men and 5 women; median, 54 years of age) with forty-eight >or=50% SAISs were enrolled. Procedural feasibility was evaluated by stent success (residual stenosis <or=30%) and procedural time. The primary end point was ischemic stroke in the target-lesion artery territory, including any stroke and death within 30 days.
Results: Forty-four lesions (91.7%) obtained stent success within a median procedural time of 50.6 minutes. Severe tortuosity correlated with stent failure. Three patients (6.5%, 3/46) had minor strokes within 30 days. All patients were available for follow-up (46 had 30-day follow-up, 45 had 6-month follow-up, 44 had 12- and 18-month follow-up, and 24 had follow-up of >or=24 months), which varied from 1 month to 30.7 months (median, 23.9 months). After 30 days, 1 patient (2.2%, 1/46) developed minor stroke in the target-lesion artery territory at 6.7 months. Primary end point rate was 4.3 per 100 patient years. Angiographic follow-up was performed in 25 patients. Seven restenoses (28%, 7/25) were detected, 1 of which was symptomatic.
Conclusion: Angioplasty with the Apollo stent for symptomatic atherosclerotic intracranial stenosis is feasible. Severe tortuosity is an independent predictor of stent failure. Our clinical outcome seems to compare favorably with results of aspirin therapy, but the restenotic rate was high.