2021Acute coronary syndromesHeart failure5661 patients

PARADISE-MI

Therapy group: ARNI · Therapy: Sacubitril/valsartan vs ramipril

In patients with myocardial infarction complicated by left ventricular dysfunction or pulmonary congestion, sacubitril/valsartan did not significantly reduce cardiovascular death or incident heart failure compared with ramipril.

Published in N Engl J Med (2021)

Question: Is sacubitril-valsartan more effective than ramipril at reducing cardiovascular death or incident heart failure in patients with complicated acute myocardial infarction?
Design: Phase 3, randomized, double-blind, active-controlled, multicenter trial that randomized 5661 patients, with a median follow-up of 22 months.
Population: Patients with myocardial infarction complicated by reduced left ventricular ejection fraction, pulmonary congestion, or both.
Intervention: Sacubitril-valsartan (97 mg sacubitril and 103 mg valsartan twice daily) on top of recommended therapy; 2830 patients.
Control: Ramipril 5 mg twice daily on top of recommended therapy; 2831 patients.
Primary outcome: Composite of cardiovascular death or incident heart failure (outpatient symptomatic heart failure or heart failure leading to hospitalization), whichever occurred first.
Results: The primary outcome occurred in 338 patients (11.9%) with sacubitril-valsartan and 373 (13.2%) with ramipril (HR 0.90; 95% CI 0.78 to 1.04; P = 0.17). Cardiovascular death was 5.9% versus 6.7% (HR 0.87; 95% CI 0.71 to 1.08).
Safety: Treatment was discontinued because of an adverse event in 357 patients (12.6%) with sacubitril-valsartan and 379 (13.4%) with ramipril.
Conclusion: Sacubitril-valsartan was not associated with a significantly lower incidence of cardiovascular death or incident heart failure than ramipril after acute myocardial infarction.
Why it matters: Although neutral for the primary endpoint, the trial provided direct evidence on using an angiotensin receptor-neprilysin inhibitor versus an ACE inhibitor in the acute infarction setting, where such comparisons had been lacking.

Card generated automatically with AI from the abstract of the original publication and the trial registry; every figure was checked against those sources. It may contain errors: verify the data at the source before using it for clinical decisions.

Generated on October 14, 2026

Sources

Original publication on PubMed (PMID 34758252) ↗Angiotensin Receptor-Neprilysin Inhibition in Acute Myocardial Infarction.
Journal article (DOI) ↗
ClinicalTrials.gov record (NCT02924727) ↗

Videos explaining it

ESC TV at #ESCCongress 2022 - PARADISE-MI

ESC · European Society of Cardiology ↗1:30Video page

Source: European Society of Cardiology · YouTube
Date: 29 Aug 2022
Audio: English
Subtitles: MultilingualYouTube
Audio transl.: None

All videos explaining it · 5 videos