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采用高敏方法连续检测慢性心力衰竭患者心肌肌钙蛋白 T:来自 2 项大型随机临床试验的数据。

Serial measurement of cardiac troponin T using a highly sensitive assay in patients with chronic heart failure: data from 2 large randomized clinical trials.

机构信息

Department of Cardiovascular Research, Istituto Mario Negri, via Giuseppe La Masa 19, 20156 Milan, Italy.

出版信息

Circulation. 2012 Jan 17;125(2):280-8. doi: 10.1161/CIRCULATIONAHA.111.044149. Epub 2011 Dec 2.

DOI:10.1161/CIRCULATIONAHA.111.044149
PMID:22139751
Abstract

BACKGROUND

Cardiac troponins are emerging as important prognostic markers in chronic cardiovascular conditions like stable coronary artery disease or chronic heart failure (HF). Less is known about the relation between serial measurements of high-sensitivity cardiac troponin T (hs-cTnT) and future events in HF. We determined the association between changes over time in hs-cTnT and outcome in patients with chronic HF.

METHODS AND RESULTS

We analyzed 5284 patients with chronic HF from 2 independent randomized clinical trials, the Valsartan Heart Failure Trial (Val-HeFT) (n=4053) and the Gruppo Italiano per lo Studio della Sopravvivenza nell'Insufficienza Cardiaca-Heart Failure (GISSI-HF) trial (n=1231). hs-cTnT was measured at randomization and after 3 months (GISSI-HF) or 4 months of follow-up (Val-HeFT). The association between changes over time of hs-cTnT and various outcomes was tested in multivariable models. In both studies, increases in hs-cTnT levels over time were associated with age, diabetes mellitus, worsening of renal function (reduction in estimated glomerular filtration rate), and baseline and increases in N-terminal pro-brain natriuretic peptide concentrations. Increases in hs-cTnT concentrations were associated with all-cause mortality (incidence rates, 8.19 [7.51-8.88] and 6.79 [5.98-7.61] per 100 person-years in Val-HeFT and GISSI-HF, respectively, with hazard ratios [95% confidence intervals] of 1.59 [1.39-1.82] and 1.88 [1.50-2.35]) after adjustment for conventional risk factors and baseline levels of hs-cTnT and N-terminal pro-brain natriuretic peptide. Changes in hs-cTnT concentration modestly improved prognostic discrimination beyond baseline values for fatal outcomes only.

CONCLUSIONS

Despite very low circulating concentrations, changes in hs-cTnT concentrations over time are robust predictors of future cardiovascular events in patients with chronic HF but add limited prognostic discrimination.

CLINICAL TRIAL REGISTRATION

http://www.clinicaltrials.gov. Unique identifier: NCT00336336.

摘要

背景

心肌肌钙蛋白在稳定型冠状动脉疾病或慢性心力衰竭(HF)等慢性心血管疾病中作为重要的预后标志物不断涌现。关于 hs-cTnT 的连续测量与 HF 患者未来事件之间的关系,人们知之甚少。我们确定了慢性 HF 患者随时间推移 hs-cTnT 变化与结局之间的相关性。

方法和结果

我们分析了来自 2 项独立的随机临床试验,即缬沙坦心力衰竭试验(Val-HeFT)(n=4053)和意大利心力衰竭生存研究(GISSI-HF)试验(n=1231)的 5284 例慢性 HF 患者。hs-cTnT 在随机分组时和 GISSI-HF 试验中 3 个月(n=1231)或 Val-HeFT 试验中 4 个月时(n=4053)进行检测。在多变量模型中检验了 hs-cTnT 随时间变化与各种结局之间的相关性。在这两项研究中,随时间推移 hs-cTnT 水平的升高与年龄、糖尿病、肾功能恶化(估计肾小球滤过率降低)以及基线和 N-末端脑钠肽前体浓度的升高有关。hs-cTnT 浓度的升高与全因死亡率相关(发生率分别为 Val-HeFT 和 GISSI-HF 中每 100 人年 8.19 [7.51-8.88] 和 6.79 [5.98-7.61],调整了传统危险因素以及 hs-cTnT 和 N-末端脑钠肽前体的基线水平后,风险比[95%置信区间]分别为 1.59 [1.39-1.82]和 1.88 [1.50-2.35])。hs-cTnT 浓度的变化仅在致命结局的基线值之外适度提高了预后的区分能力。

结论

尽管循环浓度非常低,但随时间推移 hs-cTnT 浓度的变化是慢性 HF 患者未来心血管事件的可靠预测指标,但预后的区分能力有限。

临床试验注册

http://www.clinicaltrials.gov。独特标识符:NCT00336336。

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