PARADISE-MI
Trial question
What is the role of sacubitril/valsartan in patients with acute MI?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
24.0% female
76.0% male
N = 5661
5661 patients (1363 female, 4298 male).
Inclusion criteria: patients with MI complicated by reduced LVEF, pulmonary congestion, or both.
Key exclusion criteria: clinical instability during the 24 hours preceding randomization; an eGFR < 30 mL/min/1.73 m²; serum potassium level > 5.2 mmol/L; history of angioedema.
Interventions
N=2830 sacubitril/valsartan (97 mg of sacubitril and 103 mg of valsartan BID in addition to recommended therapy).
N=2831 ramipril (5 mg BID in addition to recommended therapy).
Primary outcome
CV death or incident heart failure
11.9%
13.2%
13.2 %
9.9 %
6.6 %
3.3 %
0.0 %
Sacubitril/valsartan
Ramipril
No significant
difference ↔
No significant difference in CV death or incident HF (11.9% vs. 13.2%; HR 0.9, 95% CI 0.78 to 1.04).
Secondary outcomes
No significant difference in CV death or hospitalization for HF (10.9% vs. 11.8%; HR 0.91, 95% CI 0.78 to 1.07).
No significant difference in CV death (5.9% vs. 6.7%; HR 0.87, 95% CI 0.71 to 1.08).
No significant difference in death from any cause (7.5% vs. 8.5%; HR 0.88, 95% CI 0.73 to 1.05).
Safety outcomes
No significant difference in treatment discontinuation due to an adverse event.
Conclusion
In patients with MI complicated by reduced LVEF, pulmonary congestion, or both, sacubitril/valsartan was not superior to ramipril with respect to CV death or incident HF.
Reference
Marc A Pfeffer, Brian Claggett, Eldrin F Lewis et al. Angiotensin Receptor-Neprilysin Inhibition in Acute Myocardial Infarction. N Engl J Med. 2021 Nov 11;385(20):1845-1855.
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