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Survival and Ventricular Enlargement Trial - SAVE
Description:
Captopril vs. placebo for mortality in acute myocardial infarction.
Hypothesis:
Captopril given early post myocardial infarction to patients with left ventricular systolic dysfunction but not overt CHF improves morbidity and mortality over a 3-year period of time.
Study Design
Study Design:
Patients Enrolled: 2,231
Mean Follow-Up: 42 months (24-60 months)
Mean Patient Age: 59 years
Female: 18%
Mean Ejection Fraction: 31%
Patient Populations:
Acute myocardial infarction (age 21-80 years)
LVEF <40%
Exclusions:
No randomization within 16 days of myocardial infarction
Overt CHF requiring vasodilator therapy
Creatinine >2.5
Co-morbid conditions limiting survival
Primary Endpoints:
All cause mortality; cardiovascular mortality; mortality combined with increased EF of at least 9% (MUGA)
Secondary Endpoints:
Cardiovascular morbidity
Severe CHF or recurrent MI
Combination of cardiovascular Morbidity/mortality
Drug/Procedures Used:
Captopril (25-50 mg tid)
Radionuclide ventriculography
Concomitant Medications:
Aspirin (59%)
nitrates (52%)
diuretics (35%)
thrombolytics (33%)
calcium channel blockers (36%)
beta blockers (42%)
digoxin (26%)
antiarrhythmics (13%)
Principal Findings:
All cause mortality reduced significantly in Captopril group (19%; p = 0.019)
Incidence of both fatal and nonfatal major cardiovascular events reduced in Captopril group including development of severe heart failure (RR 37%; p < 0.001), heart failure requiring hospitalization (RR 22%; p = 0.019), and recurrent myocardial infarction (RR 25%; p = 0.015).
In a "worst-case" analysis, incremental cost-effectiveness ratios for captopril therapy remained favorable ($8,700 to $29,200/quality-adjusted life-year) for 60- to 80-year old patients but were higher ($217,600/quality-adjusted life-year) for 50-year old patients.
Interpretation:
Long-term treatment with Captopril started early post myocardial infarction in patients with asymptomatic or minimally symptomatic left ventricular dysfunction improves survival and morbidity due to major cardiovascular events. This benefit of ACE inhibitor is recognized despite treatment with standard agents including beta blockers, thrombolytics and aspirin. Cardiovascular death and/or LV dilatation occurred in >50% of patients by 2 years.
References:
Pfeffer MA, Braunwald E, Moyé LA, et al. Effect of Captopril on Mortality and Morbidity in Patients with Left Ventricular Dysfunction after Myocardial Infarction — Results of the Survival and Ventricular Enlargement Trial. N Engl J Med 1992;327:669-77. Final Results
J Am Coll Cardiol 1995;26(4):914-9. Cost-effectiveness
Circulation 1997;96:3294-9. 2-year echo follow-up
Keywords: Myocardial Infarction, Radionuclide Ventriculography, Heart Failure, Dilatation, Coronary Disease, Ventricular Dysfunction, Left, Captopril
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