Background
In the PARADISE MI trial , sacubitril/valsartan did not reduce the primary composite outcome of time to CV death of time to first heart failure event (hospitalization or outpatient) compared to ramipril in patients with acute myocardial infarction [1].
In this analysis, additional prespecified end points were explored, which could provide information on the effects of ARNI in high-risk patients after MI. More specifically, this analysis focused on total (first and recurrent) clinical end point committee (CEC)-adjudicated and investigator-reported events.
Study design
PARADISE-MI was a double-blind, active-controlled, randomized, clinical trial in which sacubitril/valsartan was compared with ramipril in 5661 patients with acute MI and either left ventricular ejection fraction ≤40% or transient pulmonary congestion. Patients with previous heart failure of clinical instability were excluded.
Outcomes
Investigator-reported time-to-first event and occurrence of recurrent events (hospitalizations for heart failure, outpatient heart failure, or CV death).
This exploratory analysis of PARADISE-MI suggest that recurrent HF events using both CEC adjudications and investigator reports are reduced by sacubitril/valsartan. The authors conclude that these findings provide supportive information for the already indicated replacement of an ACEi with sacubitril/valsartan once the development to symptomatic HF has occurred.
1. Pfeffer MA, Claggett B, Lewis EF, Granger CB, Køber L, Maggioni AP, Mann DL, McMurray JJV, Rouleau J-L, Solomon SD, et al. Angiotensin receptor neprilysin inhibition in acute myocardial infarction. N Engl J Med. In press. doi: 10.1056/NEJMoa2104508
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