ARCHeR Registry One Year Follow-up - ARCHeR Registry One Year Follow-up

Description:

The goal of the ARCHeR registry was to evaluate stenting of the internal carotid artery using the Guidant ACCULINK™ Carotid Stent System with or without the ACCUNET™ Embolic Protection System in high-risk patients with moderate to high-grade carotid stenosis.

Study Design

Study Design:

Patients Enrolled: 437
Mean Follow Up: One year
Mean Patient Age: Mean age 70 years
Female: 33

Patient Populations:

Stenosis ≥50% in patients with symptomatic disease or stenosis ≥80% in patients with asymptomatic disease, and presence of one or more of the following high-risk criteria: ≥2 vessels with ≥70% stenosis, MI within 30 days, unstable angina, ejection fraction ≤30% or New York Heart Association class ≥III, chronic obstructive pulmonary disease, dialysis for chronic renal failure, uncontrolled diabetes, and restenotic lesion after carotid endarterectomy

Exclusions:

Recent stroke within seven days

Primary Endpoints:

Composite of death, stroke, or MI at 30 days, along with ipsilateral stroke at 12 months

Drug/Procedures Used:

The registry was conducted in three separate phases (ARCHeR 1, ARCHeR 2, and ARCHeR 3). All patients underwent stenting of the internal carotid artery using the Guidant ACCULINK™ Carotid Stent System. A total of 278 patients were also treated with the ACCUNET™ Embolic Protection System. Patients were compared to historical controls.

Concomitant Medications:

Aspirin 325 mg prior to procedure and through one year, clopidogrel 75 mg prior to procedure and for a minimum of 2-4 weeks, and heparin during the procedure with activated clotting time ≥250 seconds

Principal Findings:

The acute device success was 98.1%, 98.9%, and 99.3% for ARCHeR 1, ARCHeR 2, and ARCHeR 3, respectively. The primary composite endpoint of death, stroke, or myocardial infarction (MI) at 30 days, along with ipsilateral stroke at 12 months, was 7.6%, 8.6%, and 8.3%, respectively compared with 14.5% in historical controls. Mortality at 30 days was 2.5%, 2.2%, and 1.4%, and stroke at 30 days was 4.4%, 5.8%, and 6.2%, respectively.

Ipsilateral stroke from 31 days to 12 months occurred in one patient in ARCHeR 1 (minor stroke) and four patients in ARCHeR 2 (one nonfatal, three minor strokes). Target lesion revascularization at 12 months was 2.2% in ARCHeR 1 and 2.8% in ARCHeR 2.

Interpretation:

Among high-risk patients with moderate to high-grade carotid stenosis, use of the Guidant ACCULINK™ Carotid Stent System with or without the ACCUNET™ Embolic Protection System was safe and feasible. The composite endpoint was slightly lower compared to historical controls. Additionally, the frequency of ipsilateral stroke was low. The use of a historical control arm is a limitation of the trial, with a randomized trial comparison needed to further evaluate efficacy.

NOTE: The ACCULINK™ Carotid Stent System and the ACCUNET™ Embolic Protection System are investigational devices and not approved for use in the United States.

References:

Presented by Dr. William Gray at the American College of Cardiology Annual Scientific Session, March 2004.

Clinical Topics: Invasive Cardiovascular Angiography and Intervention, Vascular Medicine, Interventions and Vascular Medicine

Keywords: Stroke, Myocardial Infarction, Asymptomatic Diseases, Kidney Failure, Chronic, Endarterectomy, Carotid, Constriction, Pathologic, Carotid Artery, Internal, Stents, Renal Dialysis, Pulmonary Disease, Chronic Obstructive, Carotid Stenosis, United States, Diabetes Mellitus


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