Canepa Marco, Anastasia Gianluca, Ameri Pietro, Vergallo Rocco, O'Connor Christopher M, Sinagra Gianfranco, Porto Italo
Cardiovascular Unit, Department of Internal Medicine, University of Genova, Italy; Cardiovascular Unit, IRCCS Ospedale Policlinico San Martino, Genoa, Italy.
Cardiovascular Unit, Department of Internal Medicine, University of Genova, Italy.
Eur J Intern Med. 2025 Apr;134:51-58. doi: 10.1016/j.ejim.2025.02.004. Epub 2025 Feb 11.
We investigated how ischemic etiology has been assigned in heart failure with a reduced ejection fraction (HFrEF) randomized controlled trials (RCTs).
We performed a systematic review and meta-analysis of definitions, rates of ischemic etiology and of each ischemic definition component: i) coronary artery disease (CAD), ii) myocardial infarction (MI), iii) coronary revascularization, and iv) prior/current angina. A total of 145 HFrEF RCTs were selected, of which 133 (91.7 %) enrolling both ischemic and non-ischemic patients (629 patients/study on average, median age 64.8 years and ejection fraction 28.2 %). The majority of these RCTs (84.2 %) lacked of clear ischemic etiology definition. Rate of ischemic etiology was 57.8 % (122 RCTs, 169,855 patients), of CAD 53.8 % (25 RCTs, 18,756 patients), of prior MI 46.7 % (57 RCTs, 80,582 patients), of prior revascularization 39.9 % (32 RCTs, 30,730 patients), and of prior/current angina 25.5 % (22 RCTs, 25,572 patients). In studies presenting both variables, prior MI showed the strongest correlations with assigned ischemic etiology (β = 0.84, p < 0.0001, 49 RCTs), followed by prior/current angina (β = 0.84, p < 0.0001, 20 RCTs), prior revascularization (β = 0.30, p = 0.006, 28 RCTs), whereas CAD had no significant correlation (β = 0.29, p = 0.162, from 17 RCTs). Rate of prior MI decreased over time (1986-2007: 51.4 ± 11.6 %; 2008-2016: 48.2 ± 8.8 %; 2017-2023: 41.4 ± 16.6 %; p = 0.057), whereas the one of prior revascularization increased (28.3 ± 11.2 %; 40.7 ± 19.6 %; 49.3 ± 19.4 %; p = 0.048).
An accurate definition of ischemic etiology is mostly lacking in HFrEF RCTs, and primarily assigned based on investigators clinical judgment, sometimes in the presence of a prior MI, although the rate of this component showed a decline over time.
我们研究了在射血分数降低的心力衰竭（HFrEF）随机对照试验（RCT）中，缺血性病因是如何确定的。
我们对缺血性病因的定义、发生率以及每个缺血性定义组成部分进行了系统评价和荟萃分析：i）冠状动脉疾病（CAD），ii）心肌梗死（MI），iii）冠状动脉血运重建，iv）既往/当前心绞痛。共筛选出145项HFrEF RCT，其中133项（91.7%）纳入了缺血性和非缺血性患者（平均每项研究629例患者，中位年龄64.8岁，射血分数28.2%）。这些RCT中的大多数（84.2%）缺乏明确的缺血性病因定义。缺血性病因的发生率为57.8%（122项RCT，169,855例患者），CAD为53.8%（25项RCT，18,756例患者），既往MI为46.7%（57项RCT，80,582例患者），既往血运重建为39.9%（32项RCT，30,730例患者），既往/当前心绞痛为25.5%（22项RCT，25,572例患者）。在同时呈现这两个变量的研究中，既往MI与指定的缺血性病因相关性最强（β = 0.84，p < 0.0001，49项RCT），其次是既往/当前心绞痛（β = 0.84，p < 0.0001，20项RCT），既往血运重建（β = 0.30，p = 0.006，28项RCT），而CAD无显著相关性（β = 0.29，p = 0.162，17项RCT）。既往MI的发生率随时间下降（1986 - 2007年：51.4 ± 11.6%；2008 - 2016年：48.2 ± 8.8%；2017 - 2023年：41.4 ± 16.6%；p = 0.057），而既往血运重建的发生率则上升（28.3 ± 11.2%；40.7 ± 19.6%；49.3 ± 19.4%；p = 0.048）。
HFrEF RCT大多缺乏缺血性病因的准确定义，主要基于研究者的临床判断来确定，有时是在存在既往MI的情况下，尽管该组成部分的发生率随时间呈下降趋势。
