AIRE: Acute Infarction Ramipril Efficacy study
Purpose
To determine whether the ACE inhibitor ramipril reduces mortality in patients with evidence of heart failure after MI
Reference
The Acute Infarction Ramipril Efficacy (AIRE) Study Investigators. Effect of ramipril on mortality and morbidity of survivors of acute myocardial infarction with clinical evidence of heart failure. Lancet 1993;342:821–8.
AIRE: Acute Infarction Ramipril Efficacy study - TRIAL DESIGN -
Design
Multicenter, multinational, randomized, double-blind, placebo-controlled
Patients
2006 patients, aged >18 years, with evidence of heart failure 3–10 days after MI; patients with severe heart failure (usually NYHA class IV) or ongoing ischemia excluded
Follow up and primary endpoint
Average 15 months follow up. Primary endpoint all-cause mortality
Treatment
Placebo or ramipril initiated at 2.5 mg twice daily; increased to 5 mg twice daily after 2 days if tolerated
AIRE: Acute Infarction Ramipril Efficacy study - RESULTS -
Significant reduction in all-cause mortality in ramipril group compared with placebo (17 vs. 23%, relative risk reduction 23%, P=0.002)
Reduction in mortality apparent as early as 30 days and consistent across a wide range of subgroups
Fewer patients in ramipril group developed severe/resistant heart failure
No significant reduction in reinfarction or stroke
Drug well tolerated, as defined by withdrawal rate from trial: only marginally higher with ramipril
AIRE: Acute Infarction Ramipril Efficacy study - RESULTS continued-
Months after randomization
0
0
1004
982
Ramipril
Placebo
No. at risk
889
845
592
575
290
287
123
98
45
44
6
12
18
24
30
15
10
5
35
30
25
20
All-cause mortality
Placebo
Ramipril
Cumulative
mortality
(%)
Relative hazard 0.73 (95% CI 0.60
–
0.89)
P=0.002
AIRE Study Investigators.
Lancet
1993;
342
:821
–
8.
AIRE: Acute Infarction Ramipril Efficacy study - RESULTS continued-
0.4
0.6
Relative hazard
Relative hazard
0.8
1
1.2
Effect of ramipril on subgroups
<65 years
>65 years
Male
Female
<5 days
>5 days
No
Yes
Favors
ramipril
Favors
placebo
Favors
ramipril
Favors
placebo
AIRE Study Investigators.
Lancet
1993;
342
:821
–
8.
Age:
Sex:
MI to
randomization:
Angina:
1.4
1.6
0.4
0.6
0.8
1
1.2
No
Yes
No
Yes
No
Yes
No
Yes
Hypertension:
Thrombolysis:
Aspirin:
Beta-blocker:
1.4
1.6
AIRE: Acute Infarction Ramipril Efficacy study - RESULTS continued-
Primary and secondary outcomes
Primary endpoint
Death
Secondary events validated by
outcomes subcommittee
Severe/resistant heart failure
Reinfarction
Stroke
AIRE Study Investigators.
Lancet
1993;
342
:821
–
8.
AIRE: Acute Infarction Ramipril Efficacy study - SUMMARY -
In patients with non-severe heart failure after MI, ramipril commenced 3–10 days after MI and continued for a mean 15-month period:
Significantly reduced all-cause mortality
Conferred benefit independent of age, sex, hypertension, angina or concomitant therapy