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Carotid Acculink/Accunet Post-Approval Trial to Uncover Unanticipated or Rare Events Registry - CAPTURE Registry
Description:
The goal of the registry was to evaluate rare or unanticipated events among patients treated with carotid stenting using the Acculink/Accunet devices.
Study Design
Study Design:
Patients Enrolled: 2500 to date
Mean Follow Up: 30 days
Mean Patient Age: Mean age 73 years
Female: 39
Patient Populations:
Performance of carotid stenting using the Acculink/Accunet devices
Primary Endpoints:
Composite of death, stroke or MI at 30 days
Drug/Procedures Used:
Patients undergoing carotid stenting with the Acculink/Accunet devices were enrolled in a registry. Patients underwent a neurological exam pre-enrollment, at 24 hours, and at 30 days. The registry is on-going. The present analysis included the first 2500 patients in the registry.
Principal Findings:
Symptomatic disease was present in 9.3% of patients. Approximately one-third had diabetes (34.7%) and 20% were smokers. The large majority of physicians had performed at least 10 carotid stent procedures as the primary operator (71.0%).
At 30 days, death, stroke or MI had occurred in 5.7% of patients. Among the components of the composite, death had occurred in 1.6%, stroke in 4.2%, and MI in 0.9%. Among the cohort of asymptomatic patients (n=2267), the composite event rate was 4.9%, with death in 1.3%, stroke in 3.5% and MI in 0.7%. Among the cohort of symptomatic patients (n=233), the composite event rate was 14.2%, with death in 4.3%, stroke in 11.2% and MI in 2.6%. Event rates were higher in patients age ≥ 80 years (composite 8.2%, death 2.0%, stroke 6.6%, and MI 0.5%).
Interpretation:
Among patients treated with carotid stenting using the Acculink/Accunet devices, 30 day event rates were 5.7% overall, with large differences in event rates among asymptomatic and symptomatic patients.
Given the registry nature of these data, no efficacy conclusions can be made on carotid stenting as there is no comparison arm. As would be expected, event rates were highest in symptomatic patients and in elderly patients ≥ age 80 years. To date, the only randomized trial reported that compares carotid stenting with endarterectomy was the 334 patient SAPPHIRE trial, which was discontinued early but met the criteria for non-inferiority of the two strategies.
References:
Presented by Dr. William Gray at the March 2006 ACC Annual Scientific Session, Atlanta, GA.
Keywords: Endarterectomy, Stroke, Carotid Stenosis, Diabetes Mellitus, Stents
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