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The Trandolapril Cardiac Evaluation TRACE Study - TRACE
Description:
Trandolapril for mortality in MI survivors with depressed LV function.
Hypothesis:
Trandolapril would decrease death from cardiovascular causes for myocardial infarction survivors with depressed left ventricular systolic function.
Study Design
Study Design:
Patients Screened: 6,676
Patients Enrolled: 1,749
Mean Follow Up: 36 months (50 months)
Mean Patient Age: 67
Female: 29
Mean Ejection Fraction: not given
Patient Populations:
Eligible patients were enrolled provided they could tolerate a test dose of 0.5mg Trandolapril
Adults with acute myocardial infarction 2-6 days prior to trial entry
Echocardiographic ejection fraction < 35%
Exclusions:
Absolute or relative contraindication to ACE inhibitors
Severe uncontrolled diabetes mellitus
Hyponatremia
Elevated serum creatinine
Pregnancy or lactation
Acute pulmonary embolism
Vascular collagen disease
Nonischemic obstructive heart disease
Unstable angina pectoris
Severe liver disease
Neutropenia
Concurrent immunosuppressive or antineoplastic drug therapy
Drug or alcohol abuse
Treatment with another investigational drug
Primary Endpoints:
All cause mortality
Secondary Endpoints:
Cardiovascular mortality
Long-term all cause mortality
Drug/Procedures Used:
Trandolapril 1mg once daily
Concomitant Medications:
Aspirin (91%)
Beta blocker (16%)
Calcium channel antagonist (28%)
Diuretic (65%)
Nitrates (53%)
Digoxin (27%)
Principal Findings:
Relative risk of death in the Trandolapril group was reduced significantly (risk reduction = 0.78, 95% CI 0.67-0.91; p = 0.001).
Trandolapril also reduces the risk of death from cardiovascular causes (relative risk 0.75; p = 0.001).
Progression to severe heart failure was less with Trandolapril (relative risk 0.71; p = 0.003)
Risk of recurrent myocardial infarction was not significantly reduced (risk = 0.86; 95% CI 0.66-1.13; p = 0.29).
Interpretation:
"Long-term treatment with Trandolapril in patients with reduced left ventricular function soon after myocardial infarction significantly reduced the risk of overall mortality, mortality from cardiovascular causes, sudden death, and the development of severe heart failure. That mortality was reduced in a randomized study enrolling 25% of consecutive patients screened should encourage the selective use of ACE inhibition after myocardial infarction." (From Abstract)
References:
1. N Engl J Med 1995;833;1670-6. Final results
2. Am J Cardiol 1998;81(11):1292-7. Long-term prognosis
Keywords: Myocardial Infarction, Ventricular Function, Left, Risk Reduction Behavior, Indoles, Heart Failure, Death, Sudden, Cardiac
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