BACKGROUND: Each of the embolic protection devices used in carotid artery stenting (CAS) has advantages and disadvantages. The prospective, multicenter, single-arm EMPiRE Clinical Study investigated a proximally placed device (GORE Flow Reversal System) that provides distal neuroprotection during CAS by reversing blood flow in the internal carotid artery, thereby directing emboli away from the brain. METHODS: The study evaluated 30-day outcomes in 245 pivotal high-surgical-risk patients (mean age, 70 years; 32% symptomatic; 16% ≥80-years old) with carotid stenosis who underwent CAS using the flow reversal system. The primary endpoint was a major adverse event (MAE; stroke, death, myocardial infarction, or transient ischemic attack) within 30 days of CAS. The MAE rate was compared with an objective performance criterion (OPC) derived from CAS studies that included embolic protection. RESULTS: The MAE rate was 4.5% (11 patients; P=0.002 compared with the OPC). The stroke and death rate was 2.9%. No patient had a major ischemic stroke. Six patients (2.4%) had intolerance to flow reversal. The death and stroke rates in the symptomatic, asymptomatic, and octogenarian subgroups were 2.6, 3, and 2.6%, respectively, meeting American Heart Association guidelines for carotid endarterectomy. CONCLUSION: The stroke and death rate in this study was among the lowest in CAS trials. The results indicate that the flow reversal system is safe and effective when used for neuroprotection during CAS and that it provides benefits in a broad patient population.
BACKGROUND: Each of the embolic protection devices used in carotid artery stenting (CAS) has advantages and disadvantages. The prospective, multicenter, single-arm EMPiRE Clinical Study investigated a proximally placed device (GORE Flow Reversal System) that provides distal neuroprotection during CAS by reversing blood flow in the internal carotid artery, thereby directing emboli away from the brain. METHODS: The study evaluated 30-day outcomes in 245 pivotal high-surgical-risk patients (mean age, 70 years; 32% symptomatic; 16% ≥80-years old) with carotid stenosis who underwent CAS using the flow reversal system. The primary endpoint was a major adverse event (MAE; stroke, death, myocardial infarction, or transient ischemic attack) within 30 days of CAS. The MAE rate was compared with an objective performance criterion (OPC) derived from CAS studies that included embolic protection. RESULTS: The MAE rate was 4.5% (11 patients; P=0.002 compared with the OPC). The stroke and death rate was 2.9%. No patient had a major ischemic stroke. Six patients (2.4%) had intolerance to flow reversal. The death and stroke rates in the symptomatic, asymptomatic, and octogenarian subgroups were 2.6, 3, and 2.6%, respectively, meeting American Heart Association guidelines for carotid endarterectomy. CONCLUSION: The stroke and death rate in this study was among the lowest in CAS trials. The results indicate that the flow reversal system is safe and effective when used for neuroprotection during CAS and that it provides benefits in a broad patient population.
Authors: Stephan Staubach; Ralph Hein-Rothweiler; Matthias Hochadel; Manuela Segerer; Ralf Zahn; Jens Jung; Gotthard Riess; Hubert Seggewiss; Andre Schneider; Thomas Fürste; Christian Gottkehaskamp; Harald Mudra Journal: Clin Res Cardiol Date: 2012-05-30 Impact factor: 5.460
Authors: Leo H Bonati; Stavros Kakkos; Joachim Berkefeld; Gert J de Borst; Richard Bulbulia; Alison Halliday; Isabelle van Herzeele; Igor Koncar; Dominick Jh McCabe; Avtar Lal; Jean-Baptiste Ricco; Peter Ringleb; Martin Taylor-Rowan; Hans-Henning Eckstein Journal: Eur Stroke J Date: 2021-05-11
Authors: Piotr Musialek; Piotr Pieniazek; Wieslawa Tracz; Lukasz Tekieli; Tadeusz Przewlocki; Anna Kablak-Ziembicka; Rafal Motyl; Zbigniew Moczulski; Jakub Stepniewski; Mariusz Trystula; Wojciech Zajdel; Agnieszka Roslawiecka; Krzysztof Zmudka; Piotr Podolec Journal: Med Sci Monit Date: 2012-02