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European Mivazerol Trial - EMIT
Description:
Mivazerol for MI and cardiac death in high-risk surgical patients.
Hypothesis:
To determine whether mivazerol reduces the risk of myocardial infarction and cardiac death in cardiac patients undergoing vascular, thoracic/abdominal, or orthopedic surgery.
Study Design
Study Design:
Patients Screened: Not given
Patients Enrolled: 1,897
Patient Populations:
Major noncardiac surgery lasting more than 1 hour
Scheduled remain in the hospital for at least 4 days post-op.
Primary Endpoints:
Death or MI
Secondary Endpoints:
All-cause death
Cardiac death
Myocardial infarction
Drug/Procedures Used:
Mivazerol hydrochloride IV infusion 20 minutes prior to induction of anesthesia and continued for 72 hours after surgery, vs normal saline placebo.
Principal Findings:
Mivazerol moderates the catecholamine response to anesthesia and major surgery.
Vascular reconstructive surgery was scheduled for 48% of the patients, thoracic or abdominal surgery for 32%, and orthopedic surgery for 20%.
In the 1897 patients with coronary heart disease, the use of mivazerol was associated with a 10.4% decrease in death or MI and a 37% reduction in all cause deaths. Neither of these differences reached statistical significance.
In a subgroup of 904 patients undergoing vascular surgery, the mivazerol group had a 33% decrease in death or MI, a 21% decrease in myocardial infarction, a 59% reduction in all cause deaths, and a 66% reduction in cardiac deaths. The effect of mivazerol occurred between the second day and the fifth postoperative day. There was little change after the fifth day.
There was no difference in adverse effects between the mivazerol patients and the placebo patients.
Interpretation:
The study was powered to detect a 33% reduction in death or MI given a 12% event rate in the control arm. The effect of mivazerol is encouraging, but may be smaller than anticipated by the investigators. The EMIT results are hypothesis-generating; further trials are needed to refine the optimum patient population, dose, and duration of therapy.
References:
1. Presented at the XXth Congress of the European Society of Cardiology, Vienna, 1998
Keywords: Myocardial Infarction, Imidazoles, Sympatholytics, Catecholamines, Coronary Disease, Orthopedics
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