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. 2021 Jun;23(6):1040-1048.
doi: 10.1002/ejhf.2191. Epub 2021 Apr 22.

Prospective ARNI vs. ACE inhibitor trial to DetermIne Superiority in reducing heart failure Events after Myocardial Infarction (PARADISE-MI): design and baseline characteristics

Karola S Jering  1 , Brian Claggett  1 , Marc A Pfeffer  1 , Christopher Granger  2 , Lars Køber  3 , Eldrin F Lewis  4 , Aldo P Maggioni  5 , Douglas Mann  6 , John J V McMurray  7 , Jean-Lucien Rouleau  8 , Scott D Solomon  1 , Philippe G Steg  9 , Peter van der Meer  10 , Margaret Wernsing  11 , Katherine Carter  11 , Weinong Guo  11 , Yinong Zhou  11 , Martin Lefkowitz  11 , Jianjian Gong  11 , Yi Wang  11 , Bela Merkely  12 , Stella M Macin  13 , Urmil Shah  14 , Jose C Nicolau  15 , Eugene Braunwald  16
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Free article

Prospective ARNI vs. ACE inhibitor trial to DetermIne Superiority in reducing heart failure Events after Myocardial Infarction (PARADISE-MI): design and baseline characteristics

Karola S Jering et al. Eur J Heart Fail. 2021 Jun.
Free article

Abstract

Aims: Patients surviving an acute myocardial infarction (AMI) are at risk of developing symptomatic heart failure (HF) or premature death. We hypothesized that sacubitril/valsartan, effective in the treatment of chronic HF, prevents development of HF and reduces cardiovascular death following high-risk AMI compared to a proven angiotensin-converting enzyme (ACE) inhibitor. This paper describes the study design and baseline characteristics of patients enrolled in the Prospective ARNI vs. ACE inhibitor trial to DetermIne Superiority in reducing heart failure Events after Myocardial Infarction (PARADISE-MI) trial.

Methods and results: PARADISE-MI, a multinational (41 countries), double-blind, active-controlled trial, randomized patients within 0.5-7 days of presentation with index AMI to sacubitril/valsartan or ramipril. Transient pulmonary congestion and/or left ventricular ejection fraction (LVEF) ≤40% and at least one additional factor augmenting risk of HF or death (age ≥70 years, estimated glomerular filtration rate <60 mL/min/1.73 m2 , diabetes, prior myocardial infarction, atrial fibrillation, LVEF <30%, Killip class ≥III, ST-elevation myocardial infarction without reperfusion) were required for inclusion. PARADISE-MI was event-driven targeting 708 primary endpoints (cardiovascular death, HF hospitalization or outpatient development of HF). Randomization of 5669 patients occurred 4.3 ± 1.8 days from presentation with index AMI. The mean age was 64 ± 12 years, 24% were women. The majority (76%) qualified with ST-segment elevation myocardial infarction; acute percutaneous coronary intervention was performed in 88% and thrombolysis in 6%. LVEF was 37 ± 9% and 58% were in Killip class ≥II.

Conclusions: Baseline therapies in PARADISE-MI reflect advances in contemporary evidence-based care. With enrollment complete PARADISE-MI is poised to determine whether sacubitril/valsartan is more effective than a proven ACE inhibitor in preventing development of HF and cardiovascular death following AMI.

Keywords: Acute myocardial infarction; Angiotensin receptor-neprilysin inhibitor; Angiotensin-converting enzyme inhibitor; Heart failure; Sacubitril/valsartan.

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