Reviwer : Dr. Göksel Çinier

Name of the Study : Prospective ARNI vs. ACE inhibitor trial to DetermIne Superiority in reducing heart failure Events after Myocardial Infarction (PARADISE-MI)

Published Congress : ACC 2021

Link : https://onlinelibrary.wiley.com/doi/10.1002/ejhf.2191
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Background :

Previous studies demonstrated that sacubitril/valsartan reduced adverse outcomes compared to ramipril among patients with chronic heart failure. This led to class I indication for sacubitril/valsartan in this population.

Objective :

PARADISE-MI study evaluated the efficacy of sacubitril/valsartan compared to ramipril among patients who presented with acute myocardial infarction (AMI)

Methods :

In this prospective, randomized and double-blind study patients who presented with AMI were randomized to either sacubitril/valsartan (target dose 97/103 mg) or ramipril (target dose 5 mg) arms. The main inclusion criteria were the presence of left ventricular ejection fraction of less than 40% and at least one risk criteria for the development of subsequent heart failure. Primary outcome was the composite of cardiovascular death, heart failure hospitalization and outpatient development of heart failure.

Results :

Total of 2830 and 2821 patients were randomized to either sacubitril/valsartan and ramipril arms respectively. The mean follow up duration was 23 months. Primary endpoint occurred in 11.9% and 13.2% of patients in sacubitril/valsartan and ramipril arms respectively (P=0.17). There were no statistically significant differences in individual components of primary outcome.

When the outcome for first time hospitalization for heart failure was changed to total number of heart failure hospitalizations, sacubitril/valsartan was associated with 21% reduction which reached statistical significance (95% CI 0.65-0.97, p=0.02).

Conclusion :

In conclusion compared to ramipril sacubitril/valsartan did not reduce composite outcome in AMI patients.

Interpretations :

Findings from PARADISE MI showed that ARNI did not reduce primary outcomes in patients with AMI. However, findings also indicated that there is a need for differentiating first heart failure hospitalization and total number of heart failure hospitalization and for clarifying which one is more clinically important.