Neuroprotection during carotid artery stenting using the GORE flow reversal system: 30-day outcomes in the EMPiRE Clinical Study

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 CA...

Full description

Saved in:
Bibliographic Details
Published in:Catheterization and cardiovascular interventions 2011-02, Vol.77 (3), p.420-429
Main Authors: Clair, Daniel G., Hopkins, L. Nelson, Mehta, Manish, Kasirajan, Karthikeshwar, Schermerhorn, Marc, Schönholz, Claudio, Kwolek, Christopher J., Eskandari, Mark K., Powell, Richard J., Ansel, Gary M.
Format: Article
Language:English
Subjects:
Age
Aged
Aged, 80 and over
angioplasty
Angioplasty - adverse effects
Angioplasty - instrumentation
Angioplasty - mortality
Brain
carotid arteries
Carotid artery
Carotid Artery, Internal - physiopathology
Carotid Stenosis - complications
Carotid Stenosis - mortality
Carotid Stenosis - physiopathology
Carotid Stenosis - therapy
Catheterization
Clinical trials
Embolic Protection Devices
embolism
Female
Heart
Humans
Intolerance
Ischemia
Ischemic Attack, Transient - etiology
Male
Middle Aged
Myocardial infarction
Myocardial Infarction - etiology
Neuroprotection
Patient Selection
Prospective Studies
Prosthesis Design
Regional Blood Flow
Risk Assessment
Risk Factors
Stenosis
Stents
Stroke
Stroke - etiology
Time Factors
Transient ischemic attack
Treatment Outcome
United States
Citations: Items that this one cites
Items that cite this one
Online Access:Get full text
Tags: Add Tag
No Tags, Be the first to tag this record!
Description
Summary: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. © 2010 Wiley‐Liss, Inc.
ISSN:1522-1946
1522-726X
1522-726X
DOI:10.1002/ccd.22789