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

Nov 08, 2004
Font Size
A
A
A
Date Presented:
01/01/2004
Date Updated:
11/08/2004
Original Posted Date:
11/08/2004
References

Description:

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.

Hypothesis:

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.

Study Design

Study Design:

Patients Enrolled: 399
Mean Follow Up: 1 year (30 day results reported)

Patient Populations:

Carotid stenosis in patient at high risk for surgical revascularization.

Primary Endpoints:

Incidence of death, MI, and ipsilateral stroke at 1 year.

Drug/Procedures Used:

Carotid stent placement using the self-expanding Exponent stent and distal protection using the Guardwire temporary occlusion and aspiration system.

Principal Findings:

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).

Interpretation:

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.

References:

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


< Back to Listings