Background and purpose Symptomatic intracranial stenosis is a significant cause of stroke in the USA. No prospective data on long term outcomes have been reported in the literature.
Methods All patients (n=158) undergoing angioplasty and stenting at five US centers with the Gateway balloon and Wingspan stent delivery system were prospectively tracked in a formalized central database. Primary end points were major ipsilateral stroke or major ipsilateral stroke and death. Secondary end points were restenosis, minor stroke or transient ischemic attacks.
Results 158 patients with 168 stenosis were treated over a 16 month period. Stents were successfully placed in 96% of cases. Periprocedural (within 30 days) were encountered in 5.7% of cases. Long term clinical follow-up was possible on 91% (143 of 158) of patients and angiographic follow-up on 84% (133 of 158) of patients. Further ipsilateral stroke or death was 9% at an average follow-up time of 14.2 months. In-stent restenosis was 31.6% (n=42) but only 9.7% (n=13) were symptomatic.
Conclusion Intracranial angioplasty and stenting with the Wingspan system is safe and is effective at reducing the risk of stroke. This data reinforces the necessity of the ongoing randomized SAMMPRIS trial.
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Competing interests AT—US Wingspan Multicenter Group, registry funded by Boston Scientific; Boston Scientific, NFocus, Pulsar Vascular and Biomerix.