ARCHeR Registry - ARCHeR Registry

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: 30 days, 6 months, 12 months, and 30 months
Mean Patient Age: Mean age 69.4 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 CEA.

Exclusions:

Recent stroke within seven days.

Primary Endpoints:

Stroke, death, or MI at 30 days.

Secondary Endpoints:

Acute device success and clinical success, target vessel revascularization at 6 and 12 months, and duplex evaluation at 6 and 12 months.

Drug/Procedures Used:

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.

Concomitant Medications:

Acetyl salicylic acid (ASA) 325 mg for one year, clopidogrel for a minimum of 2-4 weeks, and heparin during the procedure with activated clotting time ≥250 seconds.

Principal Findings:

The procedural success rate was 92.7%. Visible debris was present in 57% of baskets. Death, myocardial infarction (MI), or stroke occurred in 7.8% of patients by 30 days. Stroke occurred in 5.3% of patients by 30 days, the majority of which were minor ipsilateral strokes (3.7%), with major stroke occurring in 1.6% of patients. The rate of 30-day mortality was 2.3%, and 30-day MI was 2.1%.

Interpretation:

Among high-risk patients with moderate to high-grade carotid stenosis, treatment with carotid stenting with or without embolic protection was feasibly performed in high-risk carotid endarterectomy (CEA) patients. The event rates were similar to those in the SAPPHIRE trial, which compared carotid stenting with endarterectomy in high-risk patients and had a composite death, MI, or stroke event rate of 5.8%.

Longer term follow-up data through 30 months are pending. 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 at Late-Breaking Trials, ACC 2003.

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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