1. Valsartan in Acute Myocardial Infarction Trial Investigators
VALIANT Trial
Valsartan in Acute Myocardial Infarction Trial Investigators
Presented at
American Heart Association
Scientific Sessions 2003
Marc A. Pfeffer, et al.
N Engl J Med 2003;349:

2. VALIANT Trial
14,703 post-MI patients with left ventricular systolic dysfunction, heart failure, or both
Randomized, double-blind, multicenter
Valsartan + captopril
Valsartan titrated to 80 mg 2x/d
Captopril titrated to 50 mg 3x/d
n=4,885
Captopril monotherapy
Titrated to 50 mg 3x/d
n=4,909
Valsartan monotherapy
Titrated to 160 mg 2x/d
n=4,909
Endpoints (follow-up mean 24.7 months):
Primary – Death from any cause during follow-up
Secondary – Death from cardiovascular causes, reinfarction, or hospitalization for heart failure
N Engl J Med 2003;349:

3. or hospitalization for HF*
VALIANT Trial
All-cause Mortality*
Valsartan vs captopril
HR 1.00, 97.5% CI , p=0.98
Combo vs captopril
HR 0.98, 97.5% CI , p=0.73
CV Death, re-MI,
or hospitalization for HF*
Valsartan vs captopril HR 0.95, p=0.20
Combo vs captopril HR 0.97, p=0.37
* Met criteria for non-inferiority of valsartan vs captopril
N Engl J Med 2003;349:

4. VALIANT Trial Adverse events
Valsartan vs captopril, p=NS
Combo vs captopril, p<0.05
In the valsartan group, hypotension and renal dysfunction occurred more frequently
In the captopril group, cough, rash, and taste disturbance occurred more frequently
N Engl J Med 2003;349:

5. VALIANT Trial
Among patients with myocardial infarction complicated by LV dysfunction, heart failure, or both, treatment with valsartan, an angiotensin-receptor blocker, alone or in combination with captopril, an ACE inhibitor, did not meet the primary endpoint of all cause mortality compared with captopril monotherapy for superiority
However, the trial did meet the criteria of non-inferiority for all-cause mortality and for CV death, reinfarction, or hospitalization for heart failure for valsartan vs captopril
Adverse events  in valsartan/captopril arm vs valsartan group or captopril arm