Myocardial infarction: asymptomatic left ventricular dysfunction: trandolapril reduced death and heart failure.

Clinical bottom line (level 1b)

  1. Patients with a myocardial infarction and left ventricular dysfunction who took trandolapril compared with placebo were less likely to die (NNT = 13 at 2 years) or develop heart failure (NNT = 19 at 2 years) .
  2. There was no clear effect on recurrent myocardial infarction.
Kober et al: New England Journal of Medicine 1995; 333 (25): 1670-1676
Expires March 2003

The study

Double-blinded concealed randomised trial with intention-to-treat
Setting: 27 acute hospitals, Denmark

1749 patients (aged mean 67 years, 72% male) with a myocardial infarction (chest pain or ECG changes with an increase in one or more cardiac enzymes to at least twice the upper limit of normal) and asymptomatic left ventricular dysfunction (ejection fraction 35% or less on echocardiography).

Excluded if
  • neutropenia, concurrent immunosuppressive or antineoplastic therapy
  • drug or alcohol abuse
  • treatment with another investigational drug
  • acute pulmonary embolism
  • vascular collagen disease
  • non-ischaemic obstructive heart disease
  • unstable angina requiring immediate invasive therapy
  • severe liver disease
  • absolute or relative contraindication to ACE inhibitor or definite need for ACE inhibitor
  • severe uncontrolled diabetes mellitus
  • hyponatraemia (Na < 125 mmol/l)
  • creatinine > 200 micromol/l
  • pregnancy or lactation
  • < 2 days or > 6 days after infarction
  • aged < 18


    • Control Group: (n = 873, 873 analysed): placebo
    Experimental Group: (n = 876, 876 analysed): trandolapril initially 1 mg daily gradually increased over 4 weeks to 4 mg daily or the highest tolerable dose

    100% followed for 24 months
    Outcome notes:
    • reinfarction : fatal or nonfatal

    The evidence

    Outcome Time to outcome CEREERRRR
    (95% CI)    		ARR
    (95% CI)    		NNT
    (95% CI)
    death 2 years 369
    (42.3%)    		 304
    (34.7%)    		 18%
    (7% to 27%)    		 7.56%
    (3.02% to 12.1%)    		 13
    (8 to 33)
    heart failure 2 years 171
    (19.6%)    		 125
    (14.3%)    		 27%
    (10% to 41%)    		 5.32%
    (1.81% to 8.82%)    		 19
    (11 to 55)
    reinfarction 2 years 113
    (12.9%)    		 99
    (11.3%)    		 13%
    (-12% to 32%)    		 1.64%
    (-1.42% to 4.70%)    		 61
    (NNT = 21 to infinity;
    NNH = 71 to infinity)

    Comments

    1. Patients on trandolapril were more likely to have a cough or hypotension.

    Citation

    1. Kober L, Torp-Pedersen C, Carlsen JE, et al: A clinical trial of the angiotension-converting-enzyme inhibitor trandolapril in patients with left ventricular dysfunction after myocardial infarction (TRACE). New England Journal of Medicine 1995; 333 (25): 1670-1676
    Search Terms: ?
    Contributor: Chris Ball and Clare Wotton, February 2000
    Reviewer:

    Clinical Question.
    Patient myocardial infarction and asymptomatic left ventricular dysfunction
    Intervention or Exposure trandolapril
    Comparison placebo
    Outcome death, heart failure