Introduction The WEAVE Trial was a post-market surveillance study evaluating the peri-procedural stroke and death rate in 152 consecutive patients who were stented with the Wingspan stent under its current on-label FDA indication for symptomatic intracranial atherosclerotic stenosis (ICAS), eight days or longer after stroke. This trial demonstrated a 2.6% peri-procedural event rate at 72 hours. The WEAVE Registry was a companion registry for 46 consecutive patients stented in an off-label usage of the Wingspan stent at the same centers as the WEAVE Trial patients. The registry demonstrated a 23.4% peri-procedural event rate that was significantly higher than the on-label trial event rate (p less than 0.0001).
Methods The peri-procedural event rate of stroke, symptomatic bleed, or death was recorded for all patients in the Trial and the Registry at 72 hours, and the clinical outcomes were verified by core study Neurologists. We evaluated potential risk factors of the stenting procedure to determine which elements were associated with a higher likelihood of peri-procedural complications, including time to stenting from last stroke, and other factors. A total of 195 patients were included in the analysis. The remaining three patients, in whom the qualifying events were not well documented, were excluded.
Results Six of 24 patients (25.0%) had events who were stented 0 to 7 days post-stroke, six of 69 patients (8.7%) had events who were stented 8 to 14 days post-stroke, and 3 of 102 patients (2.9%) had events who were stented 15 days or greater following their last stroke. Comparing the event rate in patients who were stented in the recommended time period of 8 days or longer after their last stroke (5.3%) to the event rate in patients who were stented early in the 0–7 day period (25.0%), there was a significant difference in clinical outcomes between the two groups (p = 0.0044). Other factors did not reach statistical significance independently.
Conclusions Early stenting of patients with symptomatic ICAS was the strongest predictor of poor outcome in the WEAVE Registry cohort. These results indicate that efforts should be made to temporize patients medically until day 8 or longer post-stroke to reduce the peri-procedural morbidity associated with intracranial stenting.
Disclosures M. Alexander: 2; C; Stryker Neurovascular. J. Chaloupka: 2; C; Stryker Neurovascular. A. Zauner: 2; C; Stryker Neurovascular. B. Baxter: 2; C; Stryker Neurovascular. W. Yu: 2; C; Stryker Neurovascular.
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