Problem AMI and preserved LVEF
Format Multicenter, open label, 2x2 factorial design, randomized trial
Treatment Lisinopril OR GTN (IV->PO) OR both
Control Placebo
Population 19,394 patients
Inclusion criteria Typical chest pain accompanied by ST changes, either:
->1mm ST elevation or depression in ≥1 limb leads
->2mm ST elevation or depression in ≥1 chest leads
Admitted to CCU within 24h of symptom onset
Exclusion criteria Severe CHF requiring any of study drugs
Killip class 4
High risk of further serious hemodynamic deterioration after treatment with vasodilators, judged by SBP <100 mmHg
Contraindications to study drugs:
-History of renal failure (creatinine > 2mg/dl, proteinuria >500mg/24h, or both)
-History of bilateral renal artery stenosis
-Documented allergy to study drug
-Other life-threatening disorders
Follow-up 6 months
Primary endpoint Mortality at 6 weeks
Composite of death, CHF, LVEF â‰_35%, ≥45% akinesis/dyskinesis
Secondary endpoint(s) Clinical CHF
LVEF >35%
>45% akinesis/dyskinesis
Post-infarction angina
SBP <90 mmHg for >1 h
Cardiogenic shock
Renal dysfunction
Details -
Brief summary: Lisinopril reduced mortality within 24h of AMI. No benefit from GTN.
PAPER: GISSI-3: effects of lisinopril and transdermal glyceryl trinitrate singly and together on 6-week mortality and ventricular function after acute myocardial infarction.
Date 7 May 1994
Journal Lancet. 1994 May 7;343(8906):1115-22.
Information -Lisinopril within 24h of AMI
--Significantly reduced mortality @ 6w by 11%
-No survival benefit from GTN
-Benefits present in pre-defined high risk populations of females & those >70 years old