Log in to MyACC
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
Keywords: Myocardial Infarction, Enalapril, Chest Pain, Risk Reduction Behavior, Heart Failure, Dilatation, Hypotension, Ventricular Dysfunction, Left
< Back to Listings
