Prognostic value of changes in high-sensitivity cardiac troponin T beyond biological variation in stable outpatients with cardiovascular disease: a validation study,Clinical Research in Cardiology

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Prognostic value of changes in high-sensitivity cardiac troponin T beyond biological variation in stable outpatients with cardiovascular disease: a validation study
Clinical Research in Cardiology ( IF 3.8 ) Pub Date : 2021-10-25 , DOI: 10.1007/s00392-021-01952-6
Moritz Biener ₁ , Evangelos Giannitsis ₁ , Katharina Hogrefe ₁ , Matthias Mueller-Hennessen ₁ , Hanna Fröhlich ₁ , Hugo A Katus ₁ , Norbert Frey ₁ , Lutz Frankenstein ₁ , Tobias Täger ₁

Affiliation

Objective

To evaluate the prognostic implications of longitudinal long-term changes beyond the biological variation of high-sensitivity cardiac troponin T (hs-cTnT) in outpatients with stable or asymptomatic cardiovascular disease (CV) and to assess possible differences in the prognostic value while using reference change value (RCV) and minimal important differences (MID) as metric for biological variation.

Methods

Hs-cTnT was measured at index visit and after 12 months in outpatients presenting for routine follow-up. The prognostic relevance of a concentration change of hs-cTnT values exceeding the biological variation defined by RCV and MID of a healthy population within the next 12 months following the stable initial period was determined regarding three endpoints: all-cause mortality (EP1), a composite of all-cause mortality, non-fatal myocardial infarction and stroke (EP2), and a composite of all-cause mortality, non-fatal myocardial infarction, stroke, hospitalization for acute coronary syndrome (ACS) or decompensated heart failure, and planned and unplanned percutaneous coronary interventions (PCI, EP3).

Results

Change in hs-cTnT values exceeding the biovariability defined by MID but not by RCV discriminated a group with a higher cardiovascular risk profile. Changes within MID were associated with uneventful course (NPV 91.6–99.7%) while changes exceeding MID were associated with a higher occurrence of all endpoints within the next 365 days indicating a 5.5-fold increased risk for EP 1 (p = 0.041) a 2.4-fold increased risk for EP 2 (p = 0.049) and a 1.9-fold increased risk for EP 3 (p < 0.0001).

Conclusions

In stable outpatients MID calculated from hs-cTnT changes measured 365 ± 120 days apart are helpful to predict an uneventful clinical course.

Clinical trials identifier

NCT01954303.

Graphic abstract

中文翻译：

高敏心肌肌钙蛋白 T 变化在心血管疾病稳定门诊患者中超出生物学变异的预后价值：一项验证研究

客观的

评估稳定性或无症状心血管疾病 (CV) 门诊患者中高敏心肌肌钙蛋白 T (hs-cTnT) 生物学变异以外的纵向长期变化对预后的影响，并在使用参考时评估预后价值的可能差异变化值（RCV）和最小重要差异（MID）作为生物变异的度量。

方法

Hs-cTnT 在初次就诊时和 12 个月后在门诊进行常规随访的患者中进行测量。在稳定初始期后的未来 12 个月内，hs-cTnT 值的浓度变化超过了健康人群的 RCV 和 MID 定义的生物学变异的预后相关性，确定了三个终点：全因死亡率 (EP1)、a全因死亡率、非致死性心肌梗死和卒中 (EP2) 的复合材料，以及全因死亡率、非致死性心肌梗死、卒中、急性冠状动脉综合征 (ACS) 或失代偿性心力衰竭住院和计划的复合材料和计划外的经皮冠状动脉介入治疗（PCI，EP3）。

结果

hs-cTnT 值的变化超过了由 MID 而不是由 RCV 定义的生物变异性，这区分了具有较高心血管风险特征的组。MID 内的变化与平稳的过程相关（NPV 91.6–99.7%），而超过 MID 的变化与未来 365 天内所有终点的发生率较高相关，表明 EP 1 的风险增加了 5.5 倍（p = 0.041）a 2.4 EP 2 风险增加 - 倍（p = 0.049），EP 3 风险增加 1.9 倍（p < 0.0001）。