Acute Changes in Kidney Function and Outcomes Following an Acute Myocardial Infarction: Insights from PARADISE-MI
Primary result · Serum creatinine increase ≥26.5 μmol/LResult — go to the resultOdds ratio 1.32 95% CI 1.03–1.68Authors' conclusion
Following acute MI, patients assigned to sacubitril/valsartan had a higher frequency of initial increases in serum creatinine at 1 week, compared with ramipril. In adjusted models, initial increases in serum creatinine with either treatment were not associated with adverse cardiovascular outcomes or changes in longer-term kidney function.
Study context
- Population
- Patients with acute myocardial infarction (MI)
- Participants
- 5,661 patients
- Comparison
- Sacubitril/valsartan vs ramipril
- Sacubitril/valsartann = 2,604
- Ramipriln = 2,603reference
- Primary endpoint
- Initial increase in serum creatinine (≥26.5 or ≥44 μmol/L) from baseline
- Follow-up
- Week 1
Methodological detailsdouble-blind, active-controlled, event-driven, no run-in
- Double-blind
- Active-controlled
- Event-driven
- No run-in
Primary result
Serum creatinine increase ≥26.5 μmol/L
Odds ratio
1.32
95% CI 1.03–1.68
Events by treatment group
As reported in the abstract
Further findings
| Outcome | Sacubitril/valsartan | Ramipril | OR (95% CI) | |
|---|---|---|---|---|
| Serum creatinine increase ≥44 μmol/L · week 1 | 2.2% | 1.6% | 1.37 (0.92–2.05) | |
| 0.512Odds ratio (log scale) |
Creatinine increase by SBP decline (subgroup)
- Higher odds with sacubitril/valsartan appeared restricted to patients with greater SBP decline
- Interaction p = 0.05 (≥26.5 μmol/L) and 0.001 (≥44 μmol/L)
Association of acute creatinine increase with CV composite (CV death, first HF hospitalization or outpatient HF), all-cause mortality and longer-term estimated glomerular filtration rate (eGFR) slope
- Similar across randomized arms
- P for interaction > 0.6 for all
- Neither increase ≥26.5 nor ≥44 μmol/L associated with higher risk of CV outcomes, all-cause mortality or eGFR slope differences
- Multivariable Cox regression
Original publication
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