A Clinical Trial of the Angiotensin-Converting–Enzyme Inhibitor Trandolapril in Patients with Left Ventricular Dysfunction after Myocardial Infarction
Lars Køber, M.D., Christian Torp-Pedersen, M.D., Ph.D., Jan E. Carlsen, M.D., Henning Bagger, M.D., Ph.D., Per Eliasen, M.D., Ph.D., Kjeld Lyngborg, M.D., Ph.D., Jørgen Videbæk, M.D., Ph.D., David S. Cole, Ph.D., Laurent Auclert, M.D., Nancy C. Pauly, M.D., Etienne Aliot, M.D., Stig Persson, M.D., Ph.D., A. John Camm, M.D., for The Trandolapril Cardiac Evaluation (TRACE) study group
Background Treatment with angiotensin-converting–enzyme(ACE) inhibitors reduces mortality among survivors of acutemyocardial infarction, but whether to use ACE inhibitors inall patients or only in selected patients is uncertain.
Methods We screened 6676 consecutive patients with 7001 myocardialinfarctions confirmed by enzyme studies. A total of 2606 patientshad echocardiographic evidence of left ventricular systolicdysfunction (ejection fraction, <35 percent). On days 3 to7 after infarction, 1749 patients were randomly assigned toreceive oral trandolapril (876 patients) or placebo (873 patients).The duration of follow-up was 24 to 50 months.
Results During the study period, 304 patients (34.7 percent)in the trandolapril group died, as compared with 369 (42.3 percent)in the placebo group (P = 0.001). The relative risk of deathin the trandolapril group, as compared with the placebo group,was 0.78 (95 percent confidence interval, 0.67 to 0.91). Trandolaprilalso reduced the risk of death from cardiovascular causes (relativerisk, 0.75; 95 percent confidence interval, 0.63 to 0.89; P= 0.001) and sudden death (relative risk, 0.76; 95 percent confidenceinterval, 0.59 to 0.98; P = 0.03). Progression to severe heartfailure was less frequent in the trandolapril group (relativerisk, 0.71; 95 percent confidence interval, 0.56 to 0.89; P= 0.003). In contrast, the risk of recurrent myocardial infarction(fatal or nonfatal) was not significantly reduced (relativerisk, 0.86; 95 percent confidence interval, 0.66 to 1.13; P= 0.29).
Conclusions Long-term treatment with trandolapril in patientswith reduced left ventricular function soon after myocardialinfarction significantly reduced the risk of overall mortality,mortality from cardiovascular causes, sudden death, and thedevelopment of severe heart failure. That mortality was reducedin a randomized study enrolling 25 percent of consecutive patientsscreened should encourage the selective use of ACE inhibitionafter myocardial infarction.
Source Information
From the Department of Cardiology, Gentofte University Hospital (L.K., C.T.-P.), and the Trace Study Office (J.E.C.), Copenhagen, Denmark; Esbjerg Hospital, Esbjerg, Denmark (H.B.); Slagelse Hospital, Slagelse, Denmark (P.E.); Frederiksberg Hospital, Frederiksberg, Denmark (K.L.); Bispebjerg Hospital, Copenhagen, Denmark (J.V.); the Knebworth Consultancy, Knebworth, United Kingdom (D.S.C.); Roussel–Uclaf, Romainville, France (L.A., N.C.P.); Hôpital Central, Nancy, France (E.A.); University Hospital of Malmö, Malmö, Sweden (S.P.); and St. George's Hospital Medical School, London (A.J.C.).
Address reprint requests to the TRACE Study Office, Svanemøllevej 2, DK-2100 Copenhagen, Denmark.
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