Coronary disease & ACSSecondary analysis
Sacubitril/Valsartan Compared to Ramipril in High-Risk Post-Myocardial Infarction Patients Stratified According to Use of Mineralocorticoid Receptor Antagonists: Insight from the PARADISE Myocardial Infarction (MI) Trial
- Secondary analysis of the PARADISE MI randomised trial
- subgroup analysis stratified by mineralocorticoid receptor antagonists (MRA) use
Authors' conclusion
Use of a MRA did not modify safety or clinical endpoints related to initiation of ARNI compared to ramipril in the post-MI setting in patients with LVSD and/or congestion.
Study context
- Population
- High-risk post-MI patients with left ventricular systolic dysfunction (LVSD) and/or pulmonary congestion, stratified by MRA use2,338 (41%) on MRA
- Participants
- 5,661 patients
- Comparison
- Sacubitril/valsartan vs ramipril, by MRA use
- Primary endpoint
- Worsening HF or CV death
Primary result
As reported in the abstract
Worsening HF or CV death, by MRA use (subgroup)
ARNI vs RamiprilHazard ratio (95% CI)
MRA
0.96(0.77–1.19)
no MRA
0.87(0.71–1.05)
Further findings
Primary endpoint, investigator-reported, by MRA use
- Similar findings with investigator-reported endpoints
- P = 0.61 for interaction
Safety
Safety (symptomatic hypotension, hyperkalaemia >5.5 mmol/L, permanent drug discontinuation), by MRA use
- With MRA, risk of hyperkalaemia or permanent drug discontinuation not significantly altered by ARNI
- P > 0.05 for all comparisons
- Safety of ARNI vs ramipril not altered significantly by ± MRA; similar increase in symptomatic hypotension with ARNI in both
Original publication
Sacubitril/Valsartan Compared to Ramipril in High-Risk Post-Myocardial Infarction Patients Stratified According to Use of Mineralocorticoid Receptor Antagonists: Insight from the PARADISE MI Trial. Eur J Heart Fail. Published 29 November 2023. doi:10.1002/ejhf.3079
Summarised from the published abstract; every number is checked against it