Literature
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Stenting with or without Protection in High-Risk Patients with Moderate to High-Grade Carotid Stenosis
Presented at ACC 2003
Late Breaking Clinical Trials
ARCHER Trial
ARCHER
437 high-risk patients with moderate to high-grade carotid stenosis
>50% stenosis in symptomatic patients
>80% stenosis in asymptomatic patients
>1 co-morbid condition: >2 vessels with >70% stenosis; MI within 30 days; unstable angina; EF <30% or NYHA class >III; COPD; dialysis for chronic renal failure; uncontrolled diabetes; restenotic lesion after CEA
Treatment Group A
ACCULINK? Carotid Stent System
+
ACCUNET? Embolic Protection System
(n = 278)
Treatment Group B
ACCULINK? Carotid Stent System  without protection
(n = 159)
Endpoints:
Primary  – 30 day Death, Stroke or MI
ACC 2003 Late Breaking Trials
Death/
MI/
Stroke
ARCHER: 30 Day Event Rates
ACC 2003 Late Breaking Trials
Stroke
Death
MI
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