The combination sacubitril/valsartan following high-risk AMI did not reduce the risk of cardiac failure or cardiovascular risk in patients compared against ramipril. These data were provided by the PARADISE-MI presented today during the scientific sessions at ACC 2021.
The combination sacubitril/valsartan had gathered prior evidence (basically from the PARADIGM-HF) for its superiority in terms of total mortality and hospitalization for cardiac failure vs. conversion enzyme inhibitors. This was obtained in patients with symptomatic cardiac failure and reduced ejection fraction and was the design foundation for the present study on post AMI.
The high cost of sacubitril/valsartan has made its indication scarce, even in overwhelming scenarios. The PARADISE-MI was expected to add evidence in favor of this drug combination, but its outcomes in the general post AMI population were frustrating for researchers.
On the other hand, its excellent safety profile and tolerance leave the door open to more studies in search of subgroups that might benefit from it.
The PARADISE-MI included 5669 patients from 41 countries randomized within 7 days of MI. They were all free of cardiac failure at randomization, but all had presented transient pulmonary congestion and/or <40% ejection fraction. Also, they all presented at least one additional risk factor to evolve with cardiac failure or death such as: age >70, glomerular filtration <60 ml/min/1.73 m2, diabetes, prior MI, atrial fibrillation, ejection fraction <30%, Killip class ≥III, or absence of reperfusion.
Read also: ACC 2021 | Emergent CABG for acute MI: Benefits Despite Risk.
The combined end point (cardiovascular death, need for hospitalization or new cardiac failure) at 23-month followup resulted 11.9% in the sacubitril/valsartan group vs 13.9% in the ramipril group (HR 0.90; CI 95% 0.78 to 1.04).
Original Title: Prospective ARNI versus ACE inhibitor trial to determine superiority in reducing heart failure events after myocardial infarction.
Reference: Pfeffer M et al. Presentado en el congreso de la ACC 2021.
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