Valsartan in Acute Myocardial Infarction Trial Investigators

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Presentation transcript:

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;349:1893-906

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;349:1893-906

or hospitalization for HF* VALIANT Trial All-cause Mortality* Valsartan vs captopril HR 1.00, 97.5% CI 0.90-1.11, p=0.98 Combo vs captopril HR 0.98, 97.5% CI 0.89-1.09, 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;349:1893-906

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;349:1893-906

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