TRACE: TRandolapril Cardiac Evaluation
Purpose
To determine whether long-term therapy with the ACE inhibitor trandolapril reduces morbidity and mortality in patients who have left ventricular dysfunction soon after MI
Reference
K?ber L, Torp-Pedersen C, Carlsen JR et al. for the TRACE Study Group. A clinical trial of the angiotensin-converting-enzyme inhibitor trandolapril in patients with left ventricular dysfunction after myocardial infarction. N Engl J Med 1995; 333:1670–6.
TRACE: TRandolapril Cardiac Evaluation - TRIAL DESIGN -
Design
Multicenter, randomized, double-blind, placebo-controlled
Patients
1749 patients with left ventricular systolic dysfunction (wall-motion index <1.2, ejection fraction <35%) <7 days after MI
Follow up and primary endpoint
2.0–4.1 years follow up. Primary endpoint all-cause mortality
Treatment
Matched placebo or once-daily trandolapril 1 mg for 2 days, increased to 2 mg after 2 days, increased to 4 mg after 4 weeks; reduced to 1– 2 mg daily if highest dose not tolerated
TRACE: TRandolapril Cardiac Evaluation - RESULTS -
In trandolapril group, significant reduction in:
All-cause mortality and death from cardiovascular causes
Sudden death
Progression to severe heart failure
Trend toward reduction of recurrent MI (fatal or non-fatal) in trandolapril group was not significant
Tolerance profile for trandolapril similar to that of other ACE inhibitors; cough, hypotension, peripheral vascular disorders and hyperkalemia significantly higher in trandolapril group
TRACE: TRandolapril Cardiac Evaluation - RESULTS continued -
Years after randomization
Mortality
(%)
0
0
1
2
3
4
876
873
Trandolapril
Placebo
No. at risk
677
647
613
562
319
280
20
22
20
10
40
30
50
Cumulative all-cause mortality
Relative risk 0.78
P = 0.001
K?ber et al.
N Engl J Med
1995;
333
:1670–6.
Placebo
Trandolapril
TRACE: TRandolapril Cardiac Evaluation - RESULTS continued -
P
Cardiovascular outcomes
K?ber et al.
N Engl J Med
1995;
333
:1670–6.
Relative risk
(95% CI)
Death, all causes
Death from cardiovascular causes
Sudden death
Progression to severe heart failure
Recurrent MI (fatal or non-fatal)
0.78 (0.67
–
0.91)
0.75 (0.63
–
0.89)
0.76 (0.59
–
0.98)
0.71 (0.56
–
0.89)
0.86 (0.66
–
1.13)
0.001
0.001
0.03
0.003
0.29
TRACE: TRandolapril Cardiac Evaluation - SUMMARY -
In patients with left ventricular dysfunction soon after MI, long-term trandolapril significantly reduced:
Risk of death or progression to severe heart failure
Risk of sudden death
Recurrent MI was not significantly reduced