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Aprotinin decreases the incidence of cognitive deficit following CABG and cardiopulmonary bypass: a pilot randomized controlled study

[L’aprotinine réduit l’incidence de déficit cognitif à la suite d’un PAC et de la circulation extracorporelle : une étude pilote randomisée et contrôlée]

Dominic C. Harmon, MMEDSC FCARCSI^*, Kamran G. Ghori, MB^*, Nicholas P. Eustace, MMEDSC FCARCSI^*, Sheila J. F. O'Callaghan, FFARCSI^*, Aonghus P. O'Donnell, FRCS(I) and George D. Shorten, PhD FFARCSI^*

^* From the Department of Anaesthesia and Intensive Care Medicine, and
the Department of Cardiothoracic Surgery, Cork University Hospital, University College Cork, Cork, Ireland.

Address correspondence to: Dr. Dominic Harmon, Department of Anaesthesia and Intensive Care Medicine, Cork University Hospital, Wilton Road, Cork, Ireland. Phone: 353 21 4546400 ext. 22566; Fax: 353 21 4546434; E-mail: dharmon{at}indigo.ie

Purpose: Cognitive deficit after coronary artery bypass surgery (CABG) has a high prevalence and is persistent. Meta-analysis of clinical trials demonstrates a decreased incidence of stroke after CABG when aprotinin is administrated perioperatively. We hypothesized that aprotinin administration would decrease the incidence of cognitive deficit after CABG.

Methods: Thirty-six ASA III–IV patients undergoing elective CABG were included in a prospective, randomized, single-blinded pilot study. Eighteen patients received aprotinin 2 x 10⁶ KIU (loading dose), 2 x 10⁶ KIU (added to circuit prime) and a continuous infusion of 5 x 10⁵ KIU•hr^–1. A battery of cognitive tests was administered to patients and spouses (n = 18) the day before surgery, four days and six weeks postoperatively.

Results: Four days postoperatively new cognitive deficit (defined by a change in one or more cognitive domains using the Reliable Change Index method) was present in ten (58%) patients in the aprotinin group compared to 17 (94%) in the placebo group [95% confidence interval (CI) 0.10–0.62, P = 0.005); (P = 0.01)]. Six weeks postoperatively, four (23%) patients in the aprotinin group had cognitive deficit compared to ten (55%) in the placebo group (95% CI 0.80–0.16, P = 0.005); (P = 0.05).

Conclusion: In this prospective pilot study, the incidence of cognitive deficit after CABG and cardiopulmonary bypass is decreased by the administration of high-dose aprotinin.

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