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, Brian Claggett, Marc A. Pfeffer, Christopher Granger, Lars Køber, Eldrin F. Lewis, Aldo P. Maggioni, Douglas Mann, John J.V. McMurray, Jean Lucien Rouleau, Scott D. Solomon, Philippe G. Steg, Peter van der Meer, Margaret Wernsing, Katherine Carter, Weinong Guo, Yinong Zhou, Martin Lefkowitz, Jianjian Gong, Yi WangBela Merkely, Stella M. Macin, Urmil Shah, Jose C. Nicolau, Eugene Braunwald

Research output: Contribution to journalArticlepeer-review

17 Scopus citations

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.

Original languageEnglish
Pages (from-to)1040-1048
Number of pages9
JournalEuropean Journal of Heart Failure
Volume23
Issue number6
DOIs
StatePublished - Jun 2021

Keywords

  • Acute myocardial infarction
  • Angiotensin receptor–neprilysin inhibitor
  • Angiotensin-converting enzyme inhibitor
  • Heart failure
  • Sacubitril/valsartan

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