Objective: To determine whether carotid endarterectomy is superior to best
medical therapy in preserving cognition, and whether low Mini-Mental State
Examination (MMSE) scores predict TIA, stroke, myocardial infarction, or de
ath. Methods: Subjects participating in the Asymptomatic Carotid Atheroscle
rosis Study were administered the MMSE at periodic intervals. Group means w
ere calculated at randomization, 1 and 3 months later, and every 6 months t
hereafter. The group means were compared by treatment and over time. A prop
ortional hazard regression model incorporating postrandomization MMSE score
as a predictor variable was used to estimate risk of death, stroke, or oth
er outcome events. Results: There was no intergroup difference in mean MMSE
score during 5 years of observation. For individual patients, the relation
ship between a low postrandomization score on the MMSE and increased risk o
f death was significant (p less than or equal to 0.0001). Patients who expe
rienced stroke after randomization also had a significant and persistent re
duction in MMSE score (p less than or equal to 0.0001). Conclusions: Caroti
d endarterectomy had no impact on MMSE score in this study. Patients with l
ow postrandomization MMSE scores had a greater likelihood of death. Stroke
reduced MMSE scores and may portend cognitive impairment. The authors recom
mend the routine inclusion of cognitive testing in future clinical trials d
esigned to evaluate prophylaxis or acute therapy of stroke.