James Stefan, Armstrong Paul, Califf Robert, Simoons Maarten L, Venge Per, Wallentin Lars, Lindahl Bertil
Department of Cardiology, Uppsala University Hospital, Uppsala, Sweden.
Am J Med. 2003 Aug 15;115(3):178-84. doi: 10.1016/s0002-9343(03)00348-6.
A third-generation troponin T assay with improved precision and a lower detection limit has been developed. However, the appropriate cutoff for identifying patients with the acute coronary syndrome who are at low risk of subsequent mortality has not been established.
A retrospective evaluation of data from the Fragmin and fast Revascularization during InStability in Coronary artery disease II (FRISC-II) trial suggested that a cutoff below 0.1 microg/L for troponin T levels might be more useful in risk stratification. A prospective validation of two cutoff levels (0.03 microg/L and 0.01 microg/L) was performed in 7115 patients with non-ST-elevation acute coronary syndrome from the Global Utilization of Strategies To open Occluded arteries IV (GUSTO-IV) trial.
Patients with troponin T levels >0.1 microg/L had greater 30-day mortality (5.5% [201/3679]) than did those with levels <or=0.1 microg/L (2.2% [75/3436], P <0.001). A cutoff value of 0.03 microg/L provided better discrimination between high and low risk: 5.1% (234/4552) versus 1.6% (42/2563). However, a cutoff value at the lower limit of detection, 0.01 microg/L, provided the best discrimination: 5.0% (254/5123) versus 1.1% (22/1992) (P<0.001). This cutoff level had the highest negative predictive value; it also discriminated best for the combined endpoint of death and myocardial infarction.
Using a cutoff of <or=0.01 microg/L for the third-generation troponin T assay, the detection level of the assay, is useful for identifying patients with the acute coronary syndrome who are at low risk of subsequent mortality.
已研发出一种精度更高、检测限更低的第三代肌钙蛋白T检测方法。然而,用于识别急性冠状动脉综合征患者中后续死亡风险较低者的合适临界值尚未确定。
对冠心病不稳定期的Fragmin和快速血运重建II(FRISC-II)试验数据进行的回顾性评估表明,肌钙蛋白T水平低于0.1微克/升的临界值可能在风险分层中更有用。在全球应用策略开通闭塞动脉IV(GUSTO-IV)试验的7115例非ST段抬高急性冠状动脉综合征患者中,对两个临界值(0.03微克/升和0.01微克/升)进行了前瞻性验证。
肌钙蛋白T水平>0.1微克/升的患者30天死亡率(5.5%[201/3679])高于肌钙蛋白T水平≤0.1微克/升的患者(2.2%[75/3436],P<0.001)。0.03微克/升的临界值在高风险和低风险之间提供了更好的区分:5.1%(234/4552)对1.6%(42/2563)。然而,检测下限的临界值0.01微克/升提供了最佳区分:5.0%(254/5123)对1.1%(22/1992)(P<0.001)。该临界值具有最高的阴性预测值;它对死亡和心肌梗死的联合终点也有最佳区分。
对于第三代肌钙蛋白T检测,使用≤0.01微克/升的临界值(即该检测方法的检测水平),有助于识别急性冠状动脉综合征患者中后续死亡风险较低者。