PARADISE-MI 2021 (Entresto in post AMI with LV dysfunction)

Patients with acute myocardial infarction (MI) received either sacubitril/valsartan or ramipril in this randomized trial, which generated a lot of debate at the American College of Cardiology (ACC.21) about whether the trial was negative (the p-value for the primary endpoint was not statistically significant) or positive (the p-value for the secondary endpoint was statistically significant) (examination of recurrent and not just first heart failure [HF] events was significant). 


Criteria for inclusion are as follows:

  • Acute myocardial infarction is the presenting symptom.
  • Left ventricular ejection fraction (LVEF) of less than 40% with or without pulmonary congestion. 


Additionally, one of the following conditions must be met: 

  1. age less than 70 years, 
  2. atrial fibrillation, 
  3. estimated glomerular filtration rate (eGFR) less than 60, 
  4. diabetes mellitus, 
  5. prior MI, 
  6. LVEF less than 30%, 
  7. Killip class III, 
  8. ST-segment elevation MI (STEMI) without reperfusion



Criteria for exclusion include:


  • Heart failure (HF) in the past; 
  • clinical instability
  • eGFR 30 mL/min


The main outcome of cardiovascular (CV) mortality, first heart failure hospitalization, or outpatient heart failure was 11.9 percent against 13.2 percent (p = 0.17), respectively, for sacubitril/valsartan and ramipril.


CV mortality rates were 5.9 percent compared to 6.7 percent (p = 0.20).

Hospitalization for heart failure (6 percent vs. 6.9 percent, p = 0.17)


Among the secondary outcomes compared between sacubitril/valsartan and ramipril were:


CV death/MI/stroke: 11.1 percent vs. 12.3 percent (p = 0.18) in the general population.

Mortality from any cause was 7.5 percent compared to 8.5 percent (p = 0.16).

Total heart failure hospitalization, outpatient heart failure episodes, and CV mortality were 8.4 versus 10.1 per 100 patient-years (p = 0.02), respectively.

Hypotension was seen in 28.4 percent versus 22.0 percent (p 0.05).


Regardless of how you interpret the results, this long-awaited trial revealed crucial insights into how sacubitril/valsartan fits into clinical practice and definitely sparked substantial interest among the general public.


Find published trial in Euro Heart failure

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