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 Screened: Not given
Patients Enrolled: 2,231
Mean Follow Up: 42 months (24-60 months)
Mean Patient Age: 59
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:

1. N Engl J Med 1992;327:669-677. Final results
2. J Am Coll Cardiol 1995;26(4):914-9. Cost-effectiveness
3. Circulation 1997;96:3294-9. 2-year echo follow-up

Clinical Topics: Heart Failure and Cardiomyopathies, Invasive Cardiovascular Angiography and Intervention, Noninvasive Imaging, Acute Heart Failure, Interventions and Imaging, Angiography, Nuclear Imaging

Keywords: Myocardial Infarction, Radionuclide Ventriculography, Heart Failure, Dilatation, Coronary Disease, Ventricular Dysfunction, Left, Captopril


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