University/British Heart Foundation Centre for Cardiovascular Science, University of Edinburgh, Queen's Medical Research Institute, United Kingdom (E.M.-H., A.A., A.S.V.S., A.R.C., P.G., K.K.L., T.F., J.P.B., D.E.N., N.L.M., N.D.).
Department of Renal Medicine, Royal Infirmary of Edinburgh, United Kingdom (E.M.-H., P.G., T.F., N.D.).
Circulation. 2018 Jan 30;137(5):425-435. doi: 10.1161/CIRCULATIONAHA.117.030320. Epub 2017 Oct 4.
High-sensitivity cardiac troponin testing may improve the risk stratification and diagnosis of myocardial infarction, but concentrations can be challenging to interpret in patients with renal impairment, and the effectiveness of testing in this group is uncertain.
In a prospective multicenter study of consecutive patients with suspected acute coronary syndrome, we evaluated the performance of high-sensitivity cardiac troponin I in those with and without renal impairment (estimated glomerular filtration rate <60mL/min/1.73m). The negative predictive value and sensitivity of troponin concentrations below the risk stratification threshold (5 ng/L) at presentation were reported for a primary outcome of index type 1 myocardial infarction, or type 1 myocardial infarction or cardiac death at 30 days. The positive predictive value and specificity at the 99th centile diagnostic threshold (16 ng/L in women, 34 ng/L in men) was determined for index type 1 myocardial infarction. Subsequent type 1 myocardial infarction and cardiac death were reported at 1 year.
Of 4726 patients identified, 904 (19%) had renal impairment. Troponin concentrations <5 ng/L at presentation identified 17% of patients with renal impairment as low risk for the primary outcome (negative predictive value, 98.4%; 95% confidence interval [CI], 96.0%-99.7%; sensitivity 98.9%; 95%CI, 97.5%-99.9%), in comparison with 56% without renal impairment (<0.001) with similar performance (negative predictive value, 99.7%; 95% CI, 99.4%-99.9%; sensitivity 98.4%; 95% CI, 97.2%-99.4%). The positive predictive value and specificity at the 99th centile were lower in patients with renal impairment at 50.0% (95% CI, 45.2%-54.8%) and 70.9% (95% CI, 67.5%-74.2%), respectively, in comparison with 62.4% (95% CI, 58.8%-65.9%) and 92.1% (95% CI, 91.2%-93.0%) in those without. At 1 year, patients with troponin concentrations >99th centile and renal impairment were at greater risk of subsequent myocardial infarction or cardiac death than those with normal renal function (24% versus 10%; adjusted hazard ratio, 2.19; 95% CI, 1.54-3.11).
In suspected acute coronary syndrome, high-sensitivity cardiac troponin identified fewer patients with renal impairment as low risk and more as high risk, but with lower specificity for type 1 myocardial infarction. Irrespective of diagnosis, patients with renal impairment and elevated cardiac troponin concentrations had a 2-fold greater risk of a major cardiac event than those with normal renal function, and should be considered for further investigation and treatment.
URL: https://www.clinicaltrials.gov. Unique identifier: NCT01852123.
高敏心肌肌钙蛋白检测可改善心肌梗死的风险分层和诊断，但在肾功能受损患者中，其浓度难以解读，且该检测在该人群中的效果尚不确定。
在一项连续疑似急性冠状动脉综合征患者的前瞻性多中心研究中，我们评估了高敏心肌肌钙蛋白 I 在肾功能受损（肾小球滤过率估计值<60mL/min/1.73m）和无肾功能受损患者中的表现。主要结局为首发时肌钙蛋白浓度低于风险分层阈值（5ng/L）预测指数 1 型心肌梗死，或 30 天内发生 1 型心肌梗死或心源性死亡的阴性预测值和敏感性。在女性 16ng/L、男性 34ng/L 的第 99 百分位诊断阈值下，确定了指数 1 型心肌梗死的阳性预测值和特异性。随后的 1 型心肌梗死和心源性死亡在 1 年内报告。
在确定的 4726 例患者中，有 904 例（19%）存在肾功能受损。首发时肌钙蛋白浓度<5ng/L 可将 17%的肾功能受损患者识别为低危（阴性预测值 98.4%；95%置信区间 [CI]，96.0%-99.7%；敏感性 98.9%；95%CI，97.5%-99.9%），与肾功能正常患者（<0.001）相比，差异有统计学意义（阴性预测值 99.7%；95%CI，99.4%-99.9%；敏感性 98.4%；95%CI，97.2%-99.4%）。在肾功能受损患者中，第 99 百分位的阳性预测值和特异性分别为 50.0%（95%CI，45.2%-54.8%）和 70.9%（95%CI，67.5%-74.2%），低于肾功能正常患者的 62.4%（95%CI，58.8%-65.9%）和 92.1%（95%CI，91.2%-93.0%）。在 1 年内，肌钙蛋白浓度高于第 99 百分位且存在肾功能受损的患者发生后续心肌梗死或心源性死亡的风险高于肾功能正常的患者（24%比 10%；调整后的危险比，2.19；95%CI，1.54-3.11）。
在疑似急性冠状动脉综合征患者中，高敏心肌肌钙蛋白检测可将较少的肾功能受损患者识别为低危，但特异性较低，而将较多的患者识别为高危。无论诊断如何，肾功能受损且肌钙蛋白浓度升高的患者发生主要心脏不良事件的风险是肾功能正常患者的 2 倍，应考虑进一步检查和治疗。
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