Comprehensive Risk Analysis of the Wingspan Stent in Relation to Target Vessels

OBJECTIVE: To facilitate understanding for the safe use of the Wingspan stent, a comprehensive literature analysis was conducted, and incidence rates of 30-day stroke or death before and after the Stenting versus Aggressive Medical Management for Preventing Recurrent Stroke in Intracranial Stenosis (SAMMPRIS) trial were compared. We also investigated the associations between 30-day stroke or death rate and four lesion vessels, the internal carotid artery (ICA), middle cerebral artery (MCA), basilar artery (BA), and vertebral artery (VA). METHODS: We searched MEDLINE, Embase, Web of Science, and Cochrane Library databases. The incidence rates of 30-day stroke or death in pre- and post-SAMMPRIS were compared using forest plots and funnel plots. RESULTS: Thirty studies (15 before and 15 after the SAMMPRIS) were identified, comprising 2071 patients. Post-SAMMPRIS studies showed lower incidence rates of 30-day stroke or death compared to the pre-SAMMPRIS studies (8.5% vs. 5.6%, p = 0.014). The odds ratio of 30-day stroke or death of the post-SAMMPRIS group compared to that of the pre-SAMMPRIS group was 0.64 (95% confidence interval: 0.45–0.92, p = 0.014). The average 30-day stroke or death rates of overall, pre-, and post-SAMMPIS studies were 1.1%, 1.1%, and 1.1% for ICA; 6.2%, 8.8%, and 5.3% for MCA; 0.9%, 6.0%, and 2.7% for VA; and 13.5%, 15.1%, and 12.5% for BA, respectively. The post-SAMMPRIS study group showed significantly lower event rates for the treatment of MCA and VA than the pre-SAMMPRIS group did (p = 0.003 and p = 0.006, respectively). The incidence rates of ischemic and hemorrhagic stroke were 3.5% and 2.0%, respectively. CONCLUSION: This systematic surveillance study indicated that the modification of the indications for use based on the results of the SAMMPRIS trial for the Wingspan stent was effective in reducing 30-day stroke or death.