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 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.


CONCLUSIONS
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.
Clair
Daniel G
DG
Department of Vascular Surgery, Heart and Vascular Institute, Cleveland Clinic Lerner College of Medicine, Cleveland, Ohio 44195, USA. CLAIRD@ccf.org
Hopkins
L Nelson
LN
Mehta
Manish
M
Kasirajan
Karthikeshwar
K
Schermerhorn
Marc
M
Schönholz
Claudio
C
Kwolek
Christopher J
CJ
Eskandari
Mark K
MK
Powell
Richard J
RJ
Ansel
Gary M
GM
D000368:Aged; D000369:Aged, 80 and over; D017130:Angioplasty / Q000009:adverse effects / Q000295:instrumentation* / Q000401:mortality; D002343:Carotid Artery, Internal / Q000503:physiopathology*; D016893:Carotid Stenosis / Q000150:complications / Q000401:mortality / Q000503:physiopathology / Q000628:therapy*; D057505:Embolic Protection Devices; D005260:Female; D006801:Humans; D002546:Ischemic Attack, Transient / Q000209:etiology; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000209:etiology; D018579:Patient Selection; D011446:Prospective Studies; D011474:Prosthesis Design; D012039:Regional Blood Flow; D018570:Risk Assessment; D012307:Risk Factors; D015607:Stents; D020521:Stroke / Q000209:etiology; D013997:Time Factors; D016896:Treatment Outcome; D014481:United States