Highlights from

ACC 2021

American College of Cardiology Annual Congress 2021

Virtual 15-17 May 2021

Sacubitril/ valsartan does not lower risk of heart failure versus ramipril

Summary: Sacubitril/ valsartan did not reduce the rate of cardiovascular (CV) death, heart failure (HF) hospitalisation, or HF in outpatients after acute myocardial infarction (MI) when compared with ramipril. These were the preliminary findings of the phase 3 PARADISE-MI trial.1

Patients who have experienced MI are known to be at risk for subsequently developing HF. Ramipril, an angiotensin converting enzyme (ACE) inhibitor, is the current standard of care for treating HF. PARADISE-MI (NCT02924727) aimed to evaluate the efficacy and safety of sacubitril/ valsartan, a first-in-class angiotensin receptor neprilysin inhibitor compared with ramipril in preventing the development of HF and CV death following MI.2 PARADISE-MI was a multicentre, randomised, double-blind, active-controlled, parallel-group phase III study, which randomised 5,669 patients across 41 countries to receive either sacubitril/ valsartan (n=2,830) or ramipril (n=2,831) within 1 week of experiencing MI. The primary outcome was time to first confirmed occurrence of a composite endpoint (ie CV death or HF requiring either hospitalisation or outpatient care). Prof Marc Pfeffer (Brigham and Women's Hospital, US) presented the preliminary results of the trial.1 After a median follow-up period of 23 months, 338 (11.9%) patients in the sacubitril/ valsartan arm and 373 (13.2%) in the ramipril arm had reached the primary endpoint, yielding a hazard ratio of 0.88 (95% CI 0.73-1.05; P=0.16). The safety profile between the two drugs was comparable, with 2,352 (83.1%) of patients in the sacubitril/ valsartan arm and 2,325 (82.1%) of patients in the ramipril arm reporting adverse events. The top two adverse events experienced by those taking sacubitril/ valsartan were hypotension (802/28.4%) and renal impairment (329/11.7%). The top two adverse events in the ramipril arm were hypotension (620/22.0%) and cough (371/13.1%).

  1. Pfeffer M A. Prospective ARNI versus ACE inhibitor trial to determine superiority in decreasing heart failure events after myocardial infarction (PARADISE-MI). ACC 2021 Scientific Session, 15-17 May 2021
  2. Khder Y, McMurray J J et al. Sacubitril/valsartan (LCZ696) in heart failure. Handb Exp Pharmacol 2017;243:133-165 [full text] (subscription required)

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