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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

医学 缬沙坦 雷米普利 内科学 危险系数 临床终点 心力衰竭 心脏病学 心肌梗塞 螺内酯 沙库比林 中止 血管紧张素转换酶抑制剂 依那普利 依瓦布拉定 置信区间 临床试验 射血分数 血压 血管紧张素转换酶 心率
作者
Morten Schou,Brian Claggett,Zi Michael Miao,Alberto Fernández,Gerasimos Filippatos,Christopher B. Granger,Karola Jering,Aldo P. Maggioni,Finnian R. Mc Causland,Julio Núñez,Jean‐Lucien Rouleau,Freny Vaghaiwalla Mody,Peter van der Meer,Dragoş Vinereanu,Martina M. McGrath,Yinong Zhou,Douglas L. Mann,Scott D. Solomon,Philippe Gabríel Steg,Eugene Braunwald,John J.V. McMurray,Marc A. Pfeffer,Lars Køber
出处
期刊:European Journal of Heart Failure [Elsevier BV]
卷期号:26 (1): 130-139 被引量:2
标识
DOI:10.1002/ejhf.3079
摘要

Abstract 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 HR MRA– 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.
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