A randomized, blinded trial of the antioxidant pegorgotein: No reduction in neuropsychological deficits, inotropic drug support, or myocardial ischemia after coronary artery bypass surgery

Objective: To determine whether patients receiving pegorgotein preoperative ly would be less likely than patients receiving placebo to demonstrate post operative cerebral or myocardial dysfunction and thus would be less likely to (1) demonstrate a decline in neuropsychologic testing after cardiopulmon ary bypass, (2) receive inotropic drug support, or (3) demonstrate electroc ardiographic signs of ischemia or infarction. Design: Prospective, randomized, blinded clinical trial. Setting: University teaching hospital and clinics. Participants: Sixty-seven patients with normal left ventricular function un dergoing elective, primary coronary artery bypass surgery. Interventions:Six to 18 hours before aortic crossclamping, patients receive d a single dose of placebo (n = 22); pegorgotein, 2,000 IU/kg intravenously (n = 23); or pegorgotein, 5,000 IU/kg intravenously (n = 22). Measurements and Main Results; Patients in the three groups were similar; t he mean ages were 65, 66, and 67 years, and there were seven, eight, and se ven women in the placebo; pegorgotein, 2,000 IU/kg; and pegorgotein, 5,000 IU/kg groups. Fifty-one of 67 patients demonstrated neuro-psychologic defic it 5 to 7 days postoperatively (n = 17, 19, and 15 for placebo, 2,000 IU/kg , and 5,000 IU/kg; p = NS). Median duration of cardiopulmonary bypass was l onger in patients with two or more deficits at 4 to 6 weeks than in those w ith fewer than two deficits (121 v 98 minutes; p = 0.04). No patient demons trated a perioperative stroke. Twenty-seven patients required inotropic dru g support after cardiopulmonary bypass (n = 8, 11, and 8 for placebo, 2,000 IU/kg, and 5,000 IU/kg; p = NS). Inotropic drug support was associated wit h history of angina (p = 0.01) and increasing weight (p = 0.03). Nine patie nts demonstrated early postoperative ischemia or infarction (n = 1, 7, and 1 for placebo, 2,000 IU/kg, and 5.000 IU/kg; p = 0.07). Conclusions: This study showed no positive influence of pegorgotein on the incidence of any of the findings and showed a trend toward an increased inc idence of myocardial ischemia or infarction. Copyright (C) 1999 by W.B. Sau nders Company.