Coronary disease & ACSRandomised controlled trial

Routine Spironolactone in Acute Myocardial Infarction

N Engl J MedPublished

  • Randomised controlled trial
  • multicentre
  • 2-by-2 factorial
  • placebo-controlled

Authors' conclusion

Among patients with myocardial infarction, spironolactone did not reduce the incidence of death from cardiovascular causes or new or worsening heart failure or the incidence of a composite of death from cardiovascular causes, myocardial infarction, stroke, or new or worsening heart failure.

Study context

Population
Patients with MI who had undergone PCI
Participants
7,062 patients · 104 centres · 14 countries
Comparison
Spironolactone vs placebo
  • Spironolactonen = 3,537
  • Placebon = 3,525reference
Primary endpoint
Two primary outcomes: total events of CV death or new or worsening HF; and first occurrence of MI, stroke, new or worsening HF or CV death
Follow-up
Median 3 years

Primary result

As reported in the abstract

Spironolactone vs PlaceboHazard ratio (95% CI)P value
first primary outcome (CV death or new/worsening HF): 183 events (1.7 per 100 patient-years) vs 220 events (2.1 per 100 patient-years); adjusted for competing risk of non-CV death
0.91(0.69–1.21)
P = 0.51
second primary outcome: 280 of 3537 (7.9%) vs 294 of 3525 (8.3%); adjusted for competing risk
0.96(0.81–1.13)
P = 0.60

Safety

Serious adverse events

Original publication

Routine Spironolactone in Acute Myocardial Infarction. N Engl J Med. Published 17 November 2024. doi:10.1056/nejmoa2405923

Summarised from the published abstract; every number is checked against it