Clinical Characteristics and Mortality of Patients Screened for Entry Into the Trandolapril Cardiac Evaluation (TRACE) Study

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In mortality studies of patients after acute myocardial infarction (AMI), exclusion of patients during selection from the screened population may be imporlant for evaluating the impact of trials, but data on patients excluded from studies are rarely presented. In the Trandolapril Cardiac Evaluation (TRACE) trial of the angiotensin-converting enzyme inhibitor trandolapril versus placebo in patients with left ventricular (LV) systolic dysfunction shortly after AMI, medical hislory, infarct complication, and survival were accounted for in all patients screened for entry. A total of 7,001 consecutive enzyme-confirmed AMls were screened for entry in 27 Danish coronory care units. The 1-year mortality of all screened AMI cases was 23% (95% confidence interval 22% to 24%). The target population of the TRACE trial were patients with LV systolic dysfunction (echocardio-graphically determined wall motion index ≤1.2, n = 2,606) within 6 days of AMI. The 1-year mortality of this group was 34 ± 2%. Patients with wall motion index >1.2 (n = 3,920) had a 1-year morlality of 12 ± 1%. Of those with wall motion index ≤1.2, 859 (33%) were excluded. A total of 1,749 were included in the study. The excluded and included groups had a 1-year mortality of 54 ± 3% and 24 ± 2%, respectively. The result of the TRACE study will be applicable to two thirds of the patients with LV systolic dysfunction; however, even with this high figure, care should be taken in extrapolating the result to the general population with reduced LV function after AMI since the group excluded from the study had a higher mortality than those who were included.

Section snippets

Methods

Patients: Details of the Trandolapril Cardiac Evaluation (TRACE) protocol have been published elsewhere.6 TRACE is a randomized, placebo-controlled, double-blind, parallel-group trial of the ACE inhibitor trandolapril among patients with LV systolic dysfunction shortly after an AMI. The primary end point of the trial is all-cause mortality.

In brief, consecutive patients with an enzyme confirmed AMI in 27 Danish hospitals were screened. An echocardiography and a medical history were obtained. LV

Results

A total of 7,001 enzyme-confirmed myocardial infarctions were screened for entry into the study at the 27 participating centers. The 7,001 infarctions represented 6,676 patients: 272 patients were screened twice, 19 three times, and 5 four times. Descriptive statistics of the 7,001 infarctions are listed in Table II. In this table, the numbers refer to infarctions, not patients. However, if descriptive statistics are calculated corresponding to initial infarction, the result is nearly the same:

Discussion

The 1-year mortality of patients with AMI screened for entry into TRACE and of those finally randomized were very similar, 23% and 24%. With regard to other studies attempting to randomize high-risk patients, a question is raised as to the possibility of extrapolating the result of the trial beyond those randomized.

The 7,001 AMIs screened for entry into TRACE were representative of the general population with AMI admitted alive to the hospital when 1-year mortality results are compared with

Acknowledgment

We thank Laurent Auclair, MD, and David Cole, PhD, for their helpful comments.

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The Trandolapril Cardiac Evaluation study was sponsored by Roussel UCLAF, Romainville, France, and Knoll AG, Ludwigshafen, Germany

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