Women's College Hospital, University of Toronto, Toronto, Ontario, Canada; Peter Munk Cardiac Centre, Toronto General Hospital, University of Toronto, Toronto, Ontario, Canada.
School of Cardiovascular and Medical Sciences, British Heart Foundation Glasgow Cardiovascular Research Centre, University of Glasgow, Glasgow, United Kingdom.
J Am Coll Cardiol. 2024 Jun 11;83(23):2233-2246. doi: 10.1016/j.jacc.2024.03.405. Epub 2024 Apr 6.
Empagliflozin reduces the risk of heart failure (HF) hospitalizations but not all-cause mortality when started within 14 days of acute myocardial infarction (AMI).
This study sought to evaluate the association of left ventricular ejection fraction (LVEF), congestion, or both, with outcomes and the impact of empagliflozin in reducing HF risk post-AMI.
In the EMPACT-MI (Trial to Evaluate the Effect of Empagliflozin on Hospitalization for Heart Failure and Mortality in Patients with Acute Myocardial Infarction) trial, patients were randomized within 14 days of an AMI complicated by either newly reduced LVEF<45%, congestion, or both, to empagliflozin (10 mg daily) or placebo and were followed up for a median of 17.9 months.
Among 6,522 patients, the mean baseline LVEF was 41 ± 9%; 2,648 patients (40.6%) presented with LVEF <45% alone, 1,483 (22.7%) presented with congestion alone, and 2,181 (33.4%) presented with both. Among patients in the placebo arm of the trial, multivariable adjusted risk for each 10-point reduction in LVEF included all-cause death or HF hospitalization (HR: 1.49; 95% CI: 1.31-1.69; P < 0.0001), first HF hospitalization (HR: 1.64; 95% CI: 1.37-1.96; P < 0.0001), and total HF hospitalizations (rate ratio [RR]: 1.89; 95% CI: 1.51-2.36; P < 0.0001). The presence of congestion was also associated with a significantly higher risk for each of these outcomes (HR: 1.52, 1.94, and RR: 2.03, respectively). Empagliflozin reduced the risk for first (HR: 0.77; 95% CI: 0.60-0.98) and total (RR: 0.67; 95% CI: 0.50-0.89) HF hospitalizations, irrespective of LVEF or congestion, or both. The safety profile of empagliflozin was consistent across baseline LVEF and irrespective of congestion status.
In patients with AMI, the severity of left ventricular dysfunction and the presence of congestion was associated with worse outcomes. Empagliflozin reduced first and total HF hospitalizations across the range of LVEF with and without congestion. (Trial to Evaluate the Effect of Empagliflozin on Hospitalization for Heart Failure and Mortality in Patients with Acute Myocardial Infarction [EMPACT-MI]; NCT04509674).
恩格列净可降低急性心肌梗死（AMI）后 14 天内发生心力衰竭（HF）住院的风险，但不能降低全因死亡率。
本研究旨在评估左心室射血分数（LVEF）、充血或两者与结局的关系，并评估恩格列净对 AMI 后降低 HF 风险的影响。
在 EMPACT-MI（恩格列净对急性心肌梗死患者心力衰竭和死亡率住院治疗影响的评估试验）试验中，AMI 后 14 天内新出现 LVEF<45%、充血或两者并存的患者被随机分为恩格列净（10mg/d）或安慰剂组，并随访中位数为 17.9 个月。
在 6522 例患者中，平均基线 LVEF 为 41±9%；2648 例（40.6%）患者单纯 LVEF<45%，1483 例（22.7%）患者单纯充血，2181 例（33.4%）患者同时存在 LVEF 降低和充血。在安慰剂组中，LVEF 每降低 10 个点，全因死亡或 HF 住院的多变量校正风险比（HR）包括在内：1.49（95%CI：1.31-1.69；P<0.0001），首次 HF 住院（HR：1.64；95%CI：1.37-1.96；P<0.0001），以及总 HF 住院（率比[RR]：1.89；95%CI：1.51-2.36；P<0.0001）。充血的存在也与这些结局的风险显著增加相关（HR：1.52，1.94，RR：2.03）。恩格列净降低了首次（HR：0.77；95%CI：0.60-0.98）和总（RR：0.67；95%CI：0.50-0.89）HF 住院的风险，无论 LVEF 或充血是否存在，或两者都存在。恩格列净的安全性特征在整个基线 LVEF 范围内一致，且与充血状态无关。
在 AMI 患者中，左心室功能障碍的严重程度和充血的存在与不良结局相关。恩格列净降低了伴有或不伴有充血的 LVEF 范围内的首次和总 HF 住院率。（恩格列净对急性心肌梗死患者心力衰竭和死亡率住院治疗影响的评估试验[EMPACT-MI]；NCT04509674）。
