Effect of mivazerol on perioperative cardiac complications during non-cardiac surgery in patients with coronary heart disease - The European Mivazerol Trial (EMIT)

Background: Mivazerol(1) is a drug with alpha(2)-agonist properties that re duces post-ganglionic noradrenaline availability and spinal efferent sympat hetic output. Methods: A double-blind randomized placebo-controlled trial was conducted i n 61 European centers during a 2.5-yr period on 2,854 patients: 1,897 with coronary heart disease and 957 patients without overt coronary heart diseas e but classified as at high risk for it. The present analysis was restricte d to those patients with previous known coronary heart disease of whom 48% had vascular surgery, 32% non-vascular thoracic or abdominal surgery, and 2 0% orthopedic surgery. Mivazerol or placebo were given intravenously from t he induction of anesthesia for up to 72 h. Results: In the 1,897 patients with established coronary heart disease, miv azerol did not reduce the primary endpoint-the combination of myocardial in farction or death-or all-cause deaths significantly. A preplanned subgroup analysis of 904 patients with known coronary heart disease undergoing vascu lar surgery showed that there were fewer primary endpoints in those receivi ng mivazerol (risk ratio [RR], 0.67; 95% CL, 0.45-0.98; P = 0.037) and fewe r cardiac deaths (6 of 454 ys. 18 of 450: RR, 0.33; 95% confidence limits, 0.15-0.82; P = 0.017), The all-cause death rate was also decreased (RR, 0.4 1; 95% CL, 0.18-0.91; P = 0.024), although there was no significant reducti on in myocardial infarction. Conclusion: The alpha(2)-adrenergic agonist, mivazerol, did not alter the r ates of myocardial infarction or cardiac death in patients with known coron ary heart disease undergoing noncardiac surgery. However, it may have prote cted patients undergoing vascular surgery from further coronary events, and a specific study of such patients is now indicated.