OBJECTIVE: To investigate associations between individual embolic protection device (EPD) use and respective center policy with periprocedural outcomes after carotid artery stenting (CAS).
METHODS: This analysis is based on the nationwide German statutory quality assurance database and was funded by Germany's Federal Joint Committee Innovation Fund (G-BA Innovationsfonds, 01VSF19016 ISAR-IQ). According to their policy towards EPD use, hospitals were categorized as routine EPD (>90%), selective EPD (10-90%), or sporadic EPD (<10%) centers. Primary study outcome was in-hospital stroke or death. Univariate and multivariate regression analyses were performed.
RESULTS: Overall, 19 302 patients who had undergone CAS between 2013 and 2016 were included. The highest in-hospital stroke or death rate was found in sporadic EPD centers, followed by selective and routine EPD centers (3.1% vs 2.9% vs 1.8%; P<0.001). Across the whole cohort, EPD use was associated with a lower in-hospital stroke or death rate (OR=0.60; 95% CI 0.50 to 0.72). In the multivariate regression analysis, EPD use was independently associated with a lower in-hospital stroke rate (aOR=0.66; 95% CI 0.46 to 0.94). Regarding center policy, routine EPD centers showed a significantly lower in-hospital mortality compared with sporadic EPD centers (aOR=0.44; 95% CI 0.22 to 0.88).
CONCLUSIONS: In a contemporary real-world cohort with low risk of selection bias, EPD use was associated with a lower in-hospital risk of stroke. A center policy of routine EPD use was associated with lower mortality. These data support routine use of EPD during CAS to enhance patient safety.