Sacubitril/valsartan compared to ramipril in high-risk post-myocardial infarction patients stratified according to use of mineralocorticoid receptor antagonists: insight from the PARADISE MI trial
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Sacubitril/valsartan compared to ramipril in high-risk post-myocardial infarction patients stratified according to use of mineralocorticoid receptor antagonists : insight from the PARADISE MI trial. / Schou, Morten; Claggett, Brian; Miao, Zi Michael; Fernandez, Alberto; Filippatos, Gerasimos; Granger, Christopher; Jering, Karola; Maggioni, Aldo P.; McCausland, Finnian; Villota, Julio Nuñez; Rouleau, Jean Lucien; Mody, Freny Vaghaiwalla; van der Meer, Peter; Vinereanu, Dragos; McGrath, Martina; Zhou, Yinong; Mann, Douglas L.; Solomon, Scott D.; Steg, Philippe Gabriel; Braunwald, Eugene; McMurray, John J.V.; Pfeffer, Marc A.; Køber, Lars.
I: European Journal of Heart Failure, Bind 26, Nr. 1, 2024, s. 130-139.Publikation: Bidrag til tidsskrift › Tidsskriftartikel › Forskning › fagfællebedømt
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TY - JOUR
T1 - Sacubitril/valsartan compared to ramipril in high-risk post-myocardial infarction patients stratified according to use of mineralocorticoid receptor antagonists
T2 - insight from the PARADISE MI trial
AU - Schou, Morten
AU - Claggett, Brian
AU - Miao, Zi Michael
AU - Fernandez, Alberto
AU - Filippatos, Gerasimos
AU - Granger, Christopher
AU - Jering, Karola
AU - Maggioni, Aldo P.
AU - McCausland, Finnian
AU - Villota, Julio Nuñez
AU - Rouleau, Jean Lucien
AU - Mody, Freny Vaghaiwalla
AU - van der Meer, Peter
AU - Vinereanu, Dragos
AU - McGrath, Martina
AU - Zhou, Yinong
AU - Mann, Douglas L.
AU - Solomon, Scott D.
AU - Steg, Philippe Gabriel
AU - Braunwald, Eugene
AU - McMurray, John J.V.
AU - Pfeffer, Marc A.
AU - Køber, Lars
N1 - Publisher Copyright: © 2023 European Society of Cardiology.
PY - 2024
Y1 - 2024
N2 - Aim: It is unknown whether safety and clinical endpoints by use of sacubitril/valsartan (an angiotensin receptor–neprilysin inhibitor [ARNI]) are affected by mineralocorticoid receptor antagonists (MRA) in high-risk myocardial infarction (MI) patients. The aim of this study was to examine whether MRA modifies safety and clinical endpoints by use of sacubitril/valsartan in patients with a MI and left ventricular systolic dysfunction (LVSD) and/or pulmonary congestion. Methods and results: Patients (n = 5661) included in the PARADISE MI trial (Prospective ARNI vs. ACE Inhibitor Trial to Determine Superiority in Reducing Heart Failure Events After MI) were stratified according to MRA. Primary outcomes in this substudy were worsening heart failure or cardiovascular death. Safety was defined as symptomatic hypotension, hyperkalaemia >5.5 mmol/L, or permanent drug discontinuation. A total of 2338 patients (41%) were treated with MRA. Safety of ARNI compared to ramipril was not altered significantly by ± MRA, and both groups had similar increase in symptomatic hypotension with ARNI. In patients taking MRA, the risk of hyperkalaemia or permanent drug discontinuation was not significantly altered by ARNI (p > 0.05 for all comparisons). The effect of ARNI compared with ramipril was similar in those who were and were not taking MRA (hazard ratio [HR]MRA 0.96, 95% confidence interval [CI] 0.77–1.19 and HRMRA– 0.87, 95% CI 0.71–1.05, for the primary endpoint; p = 0.51 for interaction [Clinical Endpoint Committee adjudicated]); similar findings were observed if investigator-reported endpoints were evaluated (p = 0.61 for interaction). Conclusions: Use of a MRA did not modify safety or clinical endpoints related to initiation of ARNI compared to ramipril in the post-MI setting in patients with LVSD and/or congestion.
AB - Aim: It is unknown whether safety and clinical endpoints by use of sacubitril/valsartan (an angiotensin receptor–neprilysin inhibitor [ARNI]) are affected by mineralocorticoid receptor antagonists (MRA) in high-risk myocardial infarction (MI) patients. The aim of this study was to examine whether MRA modifies safety and clinical endpoints by use of sacubitril/valsartan in patients with a MI and left ventricular systolic dysfunction (LVSD) and/or pulmonary congestion. Methods and results: Patients (n = 5661) included in the PARADISE MI trial (Prospective ARNI vs. ACE Inhibitor Trial to Determine Superiority in Reducing Heart Failure Events After MI) were stratified according to MRA. Primary outcomes in this substudy were worsening heart failure or cardiovascular death. Safety was defined as symptomatic hypotension, hyperkalaemia >5.5 mmol/L, or permanent drug discontinuation. A total of 2338 patients (41%) were treated with MRA. Safety of ARNI compared to ramipril was not altered significantly by ± MRA, and both groups had similar increase in symptomatic hypotension with ARNI. In patients taking MRA, the risk of hyperkalaemia or permanent drug discontinuation was not significantly altered by ARNI (p > 0.05 for all comparisons). The effect of ARNI compared with ramipril was similar in those who were and were not taking MRA (hazard ratio [HR]MRA 0.96, 95% confidence interval [CI] 0.77–1.19 and HRMRA– 0.87, 95% CI 0.71–1.05, for the primary endpoint; p = 0.51 for interaction [Clinical Endpoint Committee adjudicated]); similar findings were observed if investigator-reported endpoints were evaluated (p = 0.61 for interaction). Conclusions: Use of a MRA did not modify safety or clinical endpoints related to initiation of ARNI compared to ramipril in the post-MI setting in patients with LVSD and/or congestion.
KW - ACE inhibitors
KW - Drug adherence
KW - Heart failure
KW - Left ventricular dysfunction
KW - Mineralocorticoid receptor antagonists
KW - Myorcardial infarction
KW - Sacubitril/valsartan
U2 - 10.1002/ejhf.3079
DO - 10.1002/ejhf.3079
M3 - Journal article
C2 - 37933184
AN - SCOPUS:85178235825
VL - 26
SP - 130
EP - 139
JO - European Journal of Heart Failure
JF - European Journal of Heart Failure
SN - 1567-4215
IS - 1
ER -
ID: 383003811