30-day Results from a Prospective Registry of Carotid Stenting With the Exponent Stent and Distal Protection With the GuardWire in High Risk Patients - MAVErIC II
This was a registry evaluating the safety and efficacy of the self-expanding Exponent stent and distal protection using the Guardwire temporary occlusion and aspiration system for treatment of carotid stenosis in patients who were poor candidates for sugical revascularization.
Carotid stenting using the self-expanding Exponent stent and distal protection using the Guardwire temporary occlusion and aspiration system would be associated with a low rate of adverse events.
Patients Enrolled: 399
Mean Follow Up: 1 year (30 day results reported)
Carotid stenosis in patient at high risk for surgical revascularization.
Incidence of death, MI, and ipsilateral stroke at 1 year.
Carotid stent placement using the self-expanding Exponent stent and distal protection using the Guardwire temporary occlusion and aspiration system.
Major adverse events (Death, stroke or MI) were 5.3% at 30-days. The death rate was 2.0% (n=4). The MI rate was 2.0% (n=4). The overall stroke rate was 3.3% (n=13).
This registry reports a low 30-day adverse event rates in a large prospective trial of carotid stenting. Though these data were obtained in high-risk patients the procedures were performed by highly skilled operators in selected patients. Further randomized data comparing carotid endarterectomy to carotid stenting in patients without contraindication to surgery and with challenging lesion morphologies are forthcoming.
Ramee, S. Evaluation of the Medtronic AVE Self-expanding Carotid Stent System in the Treatment of Carotid Stenosis. Presented at Transcatheter Therapeutics 2004, Sept. 29. Washington, D.C.
Keywords: Registries, Stroke, Endarterectomy, Carotid, Carotid Stenosis, Peripheral Vascular Diseases, Stents
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