EMPACT-MI
Trial question
What is the role of empagliflozin in patients at increased risk for HF after acute MI?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
25.0% female
75.0% male
N = 6522
6522 patients (1625 female, 4897 male).
Inclusion criteria: patients who had been hospitalized for acute MI and were at risk for HF.
Key exclusion criteria: previous diagnosis of HF; taking or planning to take SGLT-2 inhibitors.
Interventions
N=3260 empagliflozin (at a dose of 10 mg daily plus standard care within 14 days after admission).
N=3262 placebo (matching placebo plus standard care within 14 days after admission).
Primary outcome
Rate of a first hospitalization for heart failure or death from any cause at a median follow-up of 17.9 months
8.2%
9.1%
9.1 %
6.8 %
4.5 %
2.3 %
0.0 %
Empagliflozin
Placebo
No significant
difference ↔
No significant difference in the rate of a first hospitalization for HF or death from any cause at a median follow-up of 17.9 months (8.2% vs. 9.1%; HR 0.9, 95% CI 0.76 to 1.06).
Secondary outcomes
No significant difference in total hospitalizations for HF or death from any cause (9.7% vs. 11.8%; HR 0.87, 95% CI 0.68 to 1.1).
No significant difference in total nonelective cardiovascular hospitalizations or death from any cause (20.4% vs. 22.4%; HR 0.92, 95% CI 0.78 to 1.07).
No significant difference in CV death (4% vs. 4%; HR 1.03, 95% CI 0.81 to 1.31).
Safety outcomes
No significant difference in adverse and serious adverse events.
Conclusion
In patients who had been hospitalized for acute MI and were at risk for HF, empagliflozin was not superior to placebo with respect to the rate of a first hospitalization for HF or death from any cause at a median follow-up of 17.9 months.
Reference
Javed Butler, W Schuyler Jones, Jacob A Udell et al. Empagliflozin after Acute Myocardial Infarction. N Engl J Med. 2024 Apr 25;390(16):1455-1466.
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