OBJECTIVE: To prospectively evaluate outcomes of high-risk patients undergoing bilateral carotid artery stenting (CAS). METHODS: A total of 747 patients at increased risk for carotid endarterectomy (CEA) were enrolled in a prospective registry at 47 US sites of the Boston Scientific EPI: A Carotid Stenting Trial for Risk Surgical Patients (BEACH) trial. Among them, 78 (10.4%) patients underwent contralateral CAS > 30 days after the primary CAS procedure. Patients were followed at 1, 6, and 12 months, and annually thereafter for 3 years. The primary endpoint was the cumulative incidence of non Q-wave myocardial infarction within 24 hours, periprocedural (<or=30 days) death, stroke or Q-wave MI, and late ipsilateral stroke or death due to neurological events from 31 days up to 12 months. The bilateral patients are independent from the pivotal cohort. RESULTS: Mean follow-up was 885 + 320 days in the bilateral and 861 + 343 in the pivotal group. The primary endpoint occurred in 6.8% (5/73) of the bilateral patients and 8.9% (40/447) of the pivotal group (P = .66). There were no statistically significant differences between the bilateral and the pivotal groups with regard to any of the components of the primary or secondary endpoints. The univariate 1-year major adverse event (MAE) free survival was 93.6% and 91.6% in the bilateral and pivotal groups, respectively (P = .55). Multivariate logistic regression analysis with adjustment for various clinical baseline factors revealed no differences in the primary endpoint when comparing the bilateral with the pivotal groups at 30 days (odds ratio [OR]: 0.8673, 95% confidence interval [CI] 0.4590-1.6389, P = .66) or 1 year (OR: 0.9102, 95% CI 0.5503-1.5053, P = .73). CONCLUSIONS: Bilateral carotid stenting is an effective treatment strategy in patients determined to be at high-risk for CEA with no increase in morbidity or mortality results extended out to one year in a prospective multicenter trial.
OBJECTIVE: To prospectively evaluate outcomes of high-risk patients undergoing bilateral carotid artery stenting (CAS). METHODS: A total of 747 patients at increased risk for carotid endarterectomy (CEA) were enrolled in a prospective registry at 47 US sites of the Boston Scientific EPI: A Carotid Stenting Trial for Risk Surgical Patients (BEACH) trial. Among them, 78 (10.4%) patients underwent contralateral CAS > 30 days after the primary CAS procedure. Patients were followed at 1, 6, and 12 months, and annually thereafter for 3 years. The primary endpoint was the cumulative incidence of non Q-wave myocardial infarction within 24 hours, periprocedural (<or=30 days) death, stroke or Q-wave MI, and late ipsilateral stroke or death due to neurological events from 31 days up to 12 months. The bilateral patients are independent from the pivotal cohort. RESULTS: Mean follow-up was 885 + 320 days in the bilateral and 861 + 343 in the pivotal group. The primary endpoint occurred in 6.8% (5/73) of the bilateral patients and 8.9% (40/447) of the pivotal group (P = .66). There were no statistically significant differences between the bilateral and the pivotal groups with regard to any of the components of the primary or secondary endpoints. The univariate 1-year major adverse event (MAE) free survival was 93.6% and 91.6% in the bilateral and pivotal groups, respectively (P = .55). Multivariate logistic regression analysis with adjustment for various clinical baseline factors revealed no differences in the primary endpoint when comparing the bilateral with the pivotal groups at 30 days (odds ratio [OR]: 0.8673, 95% confidence interval [CI] 0.4590-1.6389, P = .66) or 1 year (OR: 0.9102, 95% CI 0.5503-1.5053, P = .73). CONCLUSIONS: Bilateral carotid stenting is an effective treatment strategy in patients determined to be at high-risk for CEA with no increase in morbidity or mortality results extended out to one year in a prospective multicenter trial.