Stroke · 2009
Evaluation of the medtronic exponent self-expanding carotid stent system with the medtronic guardwire temporary occlusion and aspiration system in the treatment of carotid stenosis: combined from the MAVErIC (Medtronic AVE Self-expanding CaRotid Stent System with distal protection In the treatment of Carotid stenosis) I and MAVErIC II trials.
Клиническое исследование I фазыКлиническое исследование II фазыСтатьяПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод пока не подготовлен
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Higashida Randall T, Popma Jeffrey J, Apruzzese Patricia, Zimetbaum Peter, MAVErIC I and II Investigators
Аннотация
BACKGROUND AND PURPOSE: Embolic protection devices and improved stent technology have advanced the endovascular treatment of carotid artery disease. A combined analysis was performed of the MAVErIC (Medtronic AVE Self-expanding CaRotid Stent System with distal protection) I and II trials to evaluate the safety and feasibility of this system among patients at high risk for surgical endarterectomy.
METHODS: Four hundred ninety-eight patients were enrolled in the MAVErIC I (99 patients) and MAVErIC II (399 patients) studies from June 2001 to October 2004. The results were pooled for statistical analysis of a common primary end point, the 365-day rate of major adverse events. Clinical follow-up took place at 30 days, 6 months, and 365 days postprocedure.
RESULTS: The 365-day major adverse event rate, defined as death, stroke, or myocardial infarction within 30 days, and death, ipsilateral stroke, or myocardial infarction from days 31 to 365 was 12.5%. The incidence of neurological death through 365 days was 1.1%. The 30-day major adverse event rate was 5.4%. Subgroup analyses showed no notable differences in the 365-day major adverse event rate for symptomatic patients compared with asymptomatic patients.
CONCLUSIONS: Treatment of carotid artery disease with carotid artery stenting with a self-expanding stent and distal embolic protection results in a low 30-day adverse event rate, including the occurrence of stroke in patients at high risk for carotid endarterectomy.
METHODS: Four hundred ninety-eight patients were enrolled in the MAVErIC I (99 patients) and MAVErIC II (399 patients) studies from June 2001 to October 2004. The results were pooled for statistical analysis of a common primary end point, the 365-day rate of major adverse events. Clinical follow-up took place at 30 days, 6 months, and 365 days postprocedure.
RESULTS: The 365-day major adverse event rate, defined as death, stroke, or myocardial infarction within 30 days, and death, ipsilateral stroke, or myocardial infarction from days 31 to 365 was 12.5%. The incidence of neurological death through 365 days was 1.1%. The 30-day major adverse event rate was 5.4%. Subgroup analyses showed no notable differences in the 365-day major adverse event rate for symptomatic patients compared with asymptomatic patients.
CONCLUSIONS: Treatment of carotid artery disease with carotid artery stenting with a self-expanding stent and distal embolic protection results in a low 30-day adverse event rate, including the occurrence of stroke in patients at high risk for carotid endarterectomy.