Zentrum für Innere Medizin, Klinik für Kardiologie, Angiologie und Pneumologie, Universitätsklinikum Heidelberg, Heidelberg, Germany.
Clin Res Cardiol. 2022 Mar;111(3):333-342. doi: 10.1007/s00392-021-01952-6. Epub 2021 Oct 25.
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.
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).
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).
In stable outpatients MID calculated from hs-cTnT changes measured 365 ± 120 days apart are helpful to predict an uneventful clinical course.
NCT01954303.
评估稳定或无症状心血管疾病（CV）患者中超过高敏心肌肌钙蛋白 T（hs-cTnT）生物学变异的纵向长期变化的预后意义，并评估使用参考变化值（RCV）和最小有意义差异（MID）作为生物学变异指标时，预后价值的差异。
在稳定初始期后 12 个月内，对接受常规随访的门诊患者进行指数就诊时和 12 个月后的 hs-cTnT 测量。确定在稳定初始期后接下来的 12 个月内，hs-cTnT 值的浓度变化超过健康人群 RCV 和 MID 定义的生物学变异性时，对三个终点的预后相关性：全因死亡率（EP1）、全因死亡率、非致死性心肌梗死和中风的复合终点（EP2）以及全因死亡率、非致死性心肌梗死、中风、急性冠脉综合征（ACS）或失代偿性心力衰竭住院以及计划和非计划经皮冠状动脉介入治疗（PCI，EP3）的复合终点。
超过 MID 定义的生物变异性但未超过 RCV 定义的 hs-cTnT 值变化可区分出心血管风险较高的患者群体。在 MID 范围内的变化与无事件过程相关（NPV 91.6-99.7%），而超过 MID 的变化与接下来 365 天内所有终点的发生相关，表明 EP1 的风险增加 5.5 倍（p=0.041），EP2 的风险增加 2.4 倍（p=0.049），EP3 的风险增加 1.9 倍（p<0.0001）。
在稳定的门诊患者中，365±120 天间隔测量的 hs-cTnT 变化的 MID 有助于预测无事件的临床过程。
NCT01954303。
