The Effects of the Early Administration of Enalapril on Mortality in Patients with Acute myocardial infarction: Results of the Cooperative New Scandin - CONSENSUS II

Description:

Enalapril vs. placebo for 6-month mortality after acute MI.

Hypothesis:

Enalapril therapy started early post myocardial infarction improves 6 month survival.

Study Design

Study Design:

Patients Screened: Not given
Patients Enrolled: 6,090
NYHA Class: not measured
Mean Follow Up: 6 months
Mean Patient Age: 66
Female: 26
Mean Ejection Fraction: not measured

Patient Populations:

Acute myocardial infarction, presenting within 24 hours of chest pain onset.

Chest pain had to be associated with at least one of the following:
ST elevation in two or more contiguous leads
New, pathologic Q waves
Elevated cardiac enzymes

Exclusions:

Blood pressure < 100/60 mmHg; this was subsequently changed to 105/65 mm Hg
Need for vasopressor
Hemodynamically significant valvular stenosis
3° AV block
Sensitivity to ACE inhibitor
Other significant co-morbidity
Clear indication for treatment with ACE inhibitor (i.e., congestive heart failure)

Primary Endpoints:

Mortality at 6 months following myocardial infarction

Secondary Endpoints:

Death in one month
Cause of death
Reinfarction
Worsening heart failure

Drug/Procedures Used:

Enalaprilat initially (given parentally)
Enalapril (target dose 20 mg/day)

Concomitant Medications:

Nitrates (53%)
Beta blockers (66%)
Calcium Channel Blockers (24%)
Thrombolytic therapy (56%)

Principal Findings:

At six months, mortality was 11% in the Enalapril group and 9.9% of the placebo group.

Early hypotension occurred in 12% of the Enalapril group and 3% of placebo group (p < 0.001).

Results consistent across all subgroups.

A significant attenuation of LV dilatation was noted at 1 month in patients treated with enalapril compared with those receiving placebo. The between-group difference was most marked in patients with anterior wall infarction (p < 0.005). Volume changes beyond the first month were similar in both groups but the differences observed at 1 month were maintained.

Interpretation:

No beneficial effect of intravenous enalaprilat followed by oral enalapril on mortality when administered within 24 hours post myocardial infarction. It is important to note in this study that follow-up was for 6 months only, possibly missing a late benefit due to ACE inhibitor therapy. The benefit of ACE inhibition appears most prominent for patients with anterior myocardial infarctions. This was a "non-selective" post myocardial infarction study without heart failure or left ventricular dysfunction on entry criterion. In ISIS-4 and GISSI-3, mortality improved by 0.46% and 0.8%, respectively, with risk reductions of 9% and 11%. In view of the risk of hypotension (20% in ISIS-4, compared with placebo 10%), very early ACE inhibition may benefit a highly selected subset of patients.

References:

1. N Engl J Med 1992;327:678-684. Final results
2. Am J Cardiol 1993;72:1004-9. Echo findings

Clinical Topics: Heart Failure and Cardiomyopathies, Acute Heart Failure

Keywords: Myocardial Infarction, Enalapril, Chest Pain, Risk Reduction Behavior, Heart Failure, Dilatation, Hypotension, Ventricular Dysfunction, Left


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