PULSE-MI
Trial question
What is the role of prehospital pulse-dose corticosteroids in patients with STEMI?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
21.0% female
79.0% male
N = 530
530 patients (112 female, 418 male).
Inclusion criteria: adult patients with < 12 hours of acute chest pain and STEMI.
Key exclusion criteria: initial presentation with out-of-hospital cardiac arrest; known allergy to corticosteroids; history of manic/psychotic episodes; previous CABG; previous acute MI in the suspected culprit artery.
Interventions
N=262 prehospital corticosteroids (IV methylprednisolone 250 mg).
N=268 placebo (IV normal saline).
Primary outcome
Final infarct size on cardiac magnetic resonance imaging at 3 months
5%
6%
6.0 %
4.5 %
3.0 %
1.5 %
0.0 %
Prehospital
corticosteroids
Placebo
No significant
difference ↔
No significant difference in final infarct size on cardiac MRI at 3 months (5% vs. 6%; OR 0.87, 95% CI 0.7 to 1.1).
Secondary outcomes
Borderline significant decrease in median acute infarct size on cardiac MRI (11% vs. 16%; OR 0.78, 95% CI 0.61 to 1).
Significant increase in mean acute LVEF (53% vs. 48%; MD 4.44, 95% CI 2.01 to 6.87).
No significant difference in all-cause mortality (3% vs. 5%; HR 0.54, 95% CI 0.22 to 1.37).
Safety outcomes
No significant difference in serious adverse events.
Conclusion
In adult patients with < 12 hours of acute chest pain and STEMI, prehospital corticosteroids were not superior to placebo with respect to final infarct size on cardiac MRI at 3 months.
Reference
Jasmine Melissa Madsen, Thomas Engstrøm, Laust Emil Roelsgaard Obling et al. Prehospital Pulse-Dose Glucocorticoid in ST-Segment Elevation Myocardial Infarction: The PULSE-MI Randomized Clinical Trial. JAMA Cardiol. 2024 Oct 1;9(10):882-891.
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