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.
OBJECTIVE
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.
Higashida
Randall T
RT
Department of Radiology and Neurosurgery, University of California at San Francisco Medical Center, San Francisco, Calif 94143-0628, USA. Randall.Higashida@radiology.ucsf.edu
Popma
Jeffrey J
JJ
Apruzzese
Patricia
P
Zimetbaum
Peter
P
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000800:Angioplasty, Balloon / Q000295:instrumentation* / Q000379:methods / Q000706:statistics & numerical data; D016893:Carotid Stenosis / Q000150:complications / Q000503:physiopathology / Q000628:therapy*; D004389:Durable Medical Equipment / Q000592:standards / Q000706:statistics & numerical data; D005260:Female; D006801:Humans; D020766:Intracranial Embolism / Q000209:etiology / Q000503:physiopathology / Q000517:prevention & control*; D008297:Male; D008875:Middle Aged; D017063:Outcome Assessment, Health Care; D018579:Patient Selection; D011183:Postoperative Complications / Q000453:epidemiology / Q000503:physiopathology; D019736:Prostheses and Implants / Q000592:standards / Q000706:statistics & numerical data; D019919:Prosthesis Implantation / Q000295:instrumentation / Q000379:methods; D015607:Stents / Q000009:adverse effects / Q000592:standards* / Q000706:statistics & numerical data; D020521:Stroke / Q000503:physiopathology / Q000517:prevention & control* / Q000628:therapy*; D016896:Treatment Outcome