Quantitative evaluation of drug or device effects on ventricular remodeling as predictors of therapeutic effects on mortality in patients with heart failure and reduced ejection fraction: a meta-analytic approach.
Quantitative evaluation of drug or device effects on ventricular remodeling as predictors of therapeutic effects on mortality in patients with heart failure and reduced ejection fraction: a meta-analytic approach.
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DOI：
10.1016/j.jacc.2010.05.011
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发表时间：
2010-07-27
影响因子：
24
通讯作者：
Udelson JE
中科院分区：
文献类型：
--
作者：
Kramer DG;Trikalinos TA;Kent DM;Antonopoulos GV;Konstam MA;Udelson JE
本研究的目的是定量评估治疗引起的左心室（LV）重塑变化与左心室功能障碍（LVD）患者的长期结局之间的关系。治疗引起的左心室射血分数 (LVEF)、舒张末期容积 (EDV) 和收缩末期容积 (ESV) 的变化是否是 LVD 患者死亡率的预测因素尚不清楚。检索随机对照试验 (RCT) 来确定药物或器械疗法对 LVD 患者死亡率的影响，其中至少有 1 项随机对照试验（RCT）涉及 ≥500 名患者（死亡率试验）。然后，在 LVD 患者中确定了涉及这些疗法的所有随机对照试验，描述了 LVEF 和/或容量随时间的变化（重塑试验）。我们检查了重塑效应的大小是否与所有治疗的死亡比值比相关，或者与死亡率比值比是有利、中性还是不利相关（即，死亡率分别在统计上显着降低、不显着或在统计上显着增加）。其中包括 25 种药物/器械疗法的 30 项死亡率试验（n = 69,766 名患者；中位随访 17 个月）和相同疗法的 88 项重塑试验（n = 19,921 名患者；中位随访 6 个月）。死亡率试验中的死亡比值比与药物/器械对 LVEF（r = -0.51，p < 0.001）、EDV（r = 0.44，p = 0.002）和 ESV（r = 0.48，p = 0.002）的影响相关。在（顺序）逻辑回归中，死亡率 RCT 中出现中性或有利效应的几率随着重构试验中 LVEF 平均增加以及 EDV 和 ESV 平均降低而增加。在 LVD 患者中，药物或装置对 LV 重塑的短期试验水平治疗效果与长期试验水平对死亡率的影响相关。
The purpose of this study was to quantitatively assess the relationship between therapy-induced changes in left ventricular (LV) remodeling and longer-term outcomes in patients with left ventricular dysfunction (LVD). Whether therapy-induced changes in left ventricular ejection fraction (LVEF), end-diastolic volume (EDV), and end-systolic volume (ESV) are predictors of mortality in patients with LVD is not established. Searches for randomized controlled trials (RCTs) were conducted to identify drug or device therapies for which an effect on mortality in patients with LVD was studied in at least 1 RCT of ≥500 patients (mortality trials). Then, all RCTs involving those therapies were identified in patients with LVD that described changes in LVEF and/or volumes over time (remodeling trials). We examined whether the magnitude of remodeling effects is associated with the odds ratios for death across all therapies or associated with whether the odds ratio for mortality was favorable, neutral, or adverse (i.e., statistically significantly decreased, nonsignificant, or statistically significantly increased odds for mortality, respectively). Included were 30 mortality trials of 25 drug/device therapies (n = 69,766 patients; median follow-up 17 months) and 88 remodeling trials of the same therapies (n = 19,921 patients; median follow-up 6 months). The odds ratio for death in the mortality trials was correlated with drug/device effects on LVEF (r = −0.51, p < 0.001), EDV (r = 0.44, p = 0.002), and ESV (r = 0.48, p = 0.002). In (ordinal) logistic regressions, the odds for neutral or favorable effects in the mortality RCTs increased with mean increases in LVEF and with mean decreases in EDV and ESV in the remodeling trials. In patients with LVD, short-term trial-level therapeutic effects of a drug or device on LV remodeling are associated with longer-term trial-level effects on mortality.