RESUMO
BACKGROUND: Coronary artery bypass grafting (CABG) can be associated with postoperative cognitive impairment and ischemic stroke. No effective treatment is currently available. The aim of this study was to evaluate the effectiveness of piracetam to treat the cognitive impairment after CABG in an investigator-initiated, double-blind, placebo-controlled, randomized clinical trial. METHODS: Patients undergoing CABG (n = 98) were randomized to placebo (n = 48) or piracetam (n = 50). Study drugs were administered intravenously (150 mg/kg daily; 300 mg/kg on the day of surgery) from the day before surgery to 6 days after surgery, then orally (12 g/day) up to 6 weeks after surgery. Cognitive function was assessed before surgery (baseline) and 6 weeks after surgery (outcome) by using a battery of 12 neuropsychologic tests. The Spielberger Anxiety Inventory and the Beck Depression Inventory were also administered. The combined score derived from the standardized neuropsychologic assessments was analyzed by using an analysis of covariance with baseline and education as covariates. RESULTS: Six weeks after surgery, the combined score indicated a statistically significant treatment effect in the per protocol population (1.848, p = 0.041) and a tendency towards statistical significance in the intent-to-treat population (1.624, p = 0.064) in the group treated with piracetam, but no statistically significant treatment effect was seen in the placebo. The state of anxiety measured by the Spielberger Anxiety Inventory was decreased in both groups (-9.27 and -6.37 in the placebo and piracetam groups, respectively). CONCLUSIONS: Six weeks after CABG, cognition was significantly improved in patients treated with piracetam. Additional trials are required to confirm these effects.
