Three hundred twenty-eight (328) asymptomatic elective CEA patients with high-grade carotid artery stenosis were enrolled with written informed consent in this IRB-approved observational study (www.ClinicalTrials.gov NCT00597883). Two hundred (200) patients were taking statins at the time of surgery and 124 were not. A reference group was used to account for trauma of surgery, effects of general anesthesia, and practice effect associated with repeated neurocognitive testing, as previously described4 (link)_ENREF_8. Patients were examined with a previously described battery of neuropsychometric tests pre-operatively and 1 day post-operatively4 (link). Four (4) patients had a perioperative clinical stroke defined by significant clinical manifestations and radiographic infarcts detected by magnetic resonance imaging (N=2) or computerized axial tomography (N=2) and were excluded from neuropsychometric analysis. Three hundred twenty-four (324) asymptomatic patients completed the entire battery of neuropsychometric tests at both time points. The neuropsychometric tests evaluate a variety of cognitive domains – verbal memory, visuo-spatial organization, motor function, and executive action – as previously described4 (link).
A variety of factors affect the neuropsychometric performance of patients after CEA, but only age >75 and diabetes mellitus have been previously shown to significantly and independently affect performance5 (link)_ENREF_10. Other factors that might also affect performance, but have not been shown to independently affect performance, were evaluated as well. These included years of education, body mass index (BMI), history of smoking, extensive peripheral vascular disease (PVD), hypertension, and duration of cross-clamping of the carotid artery. We have included these factors in our uni- and multi-variate analyses.