Objective: To report the characteristics of the prospective observational cohort study "Carotid Asymptomatic Stenosis (CARAS)", including patients with asymptomatic carotid stenosis under medical treatment and their first year of follow-up, in order to estimate the risk of cerebral ischemic events.
Methods: This is a prospective observational cohort study of CARAS>60% (Nascet criteria) patients, identified in a single duplex-ultrasonography (DUS) vascular laboratory (trail registration N: NCT04825080). Patient's enrollment started in January 2019 and ended in March 2020 with the follow-up conclusion scheduled in December 2025. The aimed sample size was calculated at 300 patients for a 5-year follow-up. The primary outcome were the incidence of ipsilateral neurologic ischemic events (stokes and transient ischemic attacks [TIA]), plaque progression rate, and survival. The follow-up was scheduled at six-month intervals for clinical visit and annually for DUS examination.
Results: a total of 307 patients completed the first follow-up year. The mean age was 81±4 years, 55% were male. Contralateral stenosis >60% was present in 90 (29%) patients. Antiplatelet therapy and statins adherence was 80% and 88%, respectively. During the first year, 3 ispilateral strokes (1%) and 4 TIAs (1.3%) occurred, for a total of 2.3% ipsilateral ischemic events. During the first year, 43 (14%) plaques had a stenosis progression, which was correlated with the occurrence of neurological events (9.3% vs. 1.1%, P=.001, OR: 8.9; 95%CI: 1.9-41); 6 deaths (2%) occurred in the same period.
Conclusion: the preliminary one-year results of this prospective study suggest that the overall rate of any ipsilateral ischemic event, and specifically ipsilateral strokes, correlates with plaque progression.
Keywords: Asymptomatic; Carotid artery stenosis; Follow-up; Stroke; TIA.
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