Home > Cardiology > ACC 2021 > Heart Failure and Cardiomyopathy > PARADISE-MI: Sacubitril/valsartan not superior to ramipril in reducing HF events

PARADISE-MI: Sacubitril/valsartan not superior to ramipril in reducing HF events

Presented by
Prof. Marc Pfeffer, Brigham and Women’s Hospital, USA
Conference
ACC 2021
Trial
Phase 3, PARADISE-MI
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 according to initial findings of the phase 3 PARADISE-MI trial [1].

Patients who have experienced MI are known to be at risk for subsequently developing 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, an angiotensin-converting enzyme (ACE) inhibitor, 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 3 study, in which 5,669 patients with left ventricular systolic dysfunction and/or pulmonary congestion, but without prior history of chronic HF, were randomised to receive either sacubitril/valsartan (target dose of 97/103 mg twice daily; n=2,830) or ramipril (target dose of 5 mg twice daily; n=2,831) within 1 week of experiencing MI. The primary outcome was time to first occurrence of the composite endpoint of CV death or HF requiring either hospitalisation or outpatient care. Prof. Marc Pfeffer (Brigham and Women’s Hospital, USA) 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 2 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 2 adverse events experienced by those taking sacubitril/valsartan were hypotension (28.4%) and renal impairment (11.7%). The top 2 adverse events in the ramipril arm were hypotension (22.0%) and cough (13.1%).

Prof. Pfeffer concluded that sacubitril/valsartan showed a trend towards incremental benefit but did not significantly lower the rate of CV death, hospitalisation for HF, or outpatient HF requiring treatment when compared with ramipril. Both drugs were safe and well-tolerated.


    1. Pfeffer MA. 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.
    2. Eur J Heart Fail. 2021;Apr 12. DOI: 10.1002/ejhf.2191.

 

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