Result of the ndolapril ardiac valuation Study (TRACE).

TRACE has evaluated whether secondary prevention with the ACE inhibitor trandolapril benefits patients with left ventricular dysfunction (LVD) shortly after a myocardial infarction (MI). Between May 1990 and July 1992 6676 patients with 7001 consecutive enzyme verified MIs were screened 2-6 days after the onset of symptoms. LVD was assessed centrally by one of two experts from a standard videotaped echocardiography. 2606 patients with LVD corresponding to an ejection fraction ≤ 35% were identified. 1749 patients (67% of those eligible) were enrolled after tolerating a testdose of 0.5 mg trandolapril. Myocardial ischemia or congestive heart failure (CHF) did not preclude enrolment. Patients were randomly allocated to either oral trandolapril (1-4 mg od) or placebo 3-7 days post-MI. Observation time was 24-50 months, mean follow-up was 26.5 months. There was no difference in baseline characteristics between the two groups. By intention to treat analysis trandolapril caused a highly significant reduction in mortality, the primary endpoint of the study: there were (34.7%) deaths on trandolapril compared to (42.3%) on placebo (p=0.00065). The risk ratio of the ACE inhibitor group was 0.78 (95% Confidence Interval 0.67-0.91). The beneficial effect was evident after one month of treatment, persisted throughout the study and was consistent across important subgroups including age, sex, degree of LVD, infarct location, previous MI and history of CHF. The outcome in important subgroups will be presented.