Reichlin Tobias, Hochholzer Willibald, Bassetti Stefano, Steuer Stephan, Stelzig Claudia, Hartwiger Sabine, Biedert Stefan, Schaub Nora, Buerge Christine, Potocki Mihael, Noveanu Markus, Breidthardt Tobias, Twerenbold Raphael, Winkler Katrin, Bingisser Roland, Mueller Christian
Department of Internal Medicine, University Hospital, Basel, Switzerland.
N Engl J Med. 2009 Aug 27;361(9):858-67. doi: 10.1056/NEJMoa0900428.
The rapid and reliable diagnosis of acute myocardial infarction is a major unmet clinical need.
We conducted a multicenter study to examine the diagnostic accuracy of new, sensitive cardiac troponin assays performed on blood samples obtained in the emergency department from 718 consecutive patients who presented with symptoms suggestive of acute myocardial infarction. Cardiac troponin levels were determined in a blinded fashion with the use of four sensitive assays (Abbott-Architect Troponin I, Roche High-Sensitive Troponin T, Roche Troponin I, and Siemens Troponin I Ultra) and a standard assay (Roche Troponin T). The final diagnosis was adjudicated by two independent cardiologists.
Acute myocardial infarction was the adjudicated final diagnosis in 123 patients (17%). The diagnostic accuracy of measurements obtained at presentation, as quantified by the area under the receiver-operating-characteristic curve (AUC), was significantly higher with the four sensitive cardiac troponin assays than with the standard assay (AUC for Abbott-Architect Troponin I, 0.96; 95% confidence interval [CI], 0.94 to 0.98; for Roche High-Sensitive Troponin T, 0.96; 95% CI, 0.94 to 0.98; for Roche Troponin I, 0.95; 95% CI, 0.92 to 0.97; and for Siemens Troponin I Ultra, 0.96; 95% CI, 0.94 to 0.98; vs. AUC for the standard assay, 0.90; 95% CI, 0.86 to 0.94). Among patients who presented within 3 hours after the onset of chest pain, the AUCs were 0.93 (95% CI, 0.88 to 0.99), 0.92 (95% CI, 0.87 to 0.97), 0.92 (95% CI, 0.86 to 0.99), and 0.94 (95% CI, 0.90 to 0.98) for the sensitive assays, respectively, and 0.76 (95% CI, 0.64 to 0.88) for the standard assay. We did not assess the effect of the sensitive troponin assays on clinical management.
The diagnostic performance of sensitive cardiac troponin assays is excellent, and these assays can substantially improve the early diagnosis of acute myocardial infarction, particularly in patients with a recent onset of chest pain. (ClinicalTrials.gov number, NCT00470587.)
急性心肌梗死的快速、可靠诊断是一项尚未满足的重大临床需求。
我们开展了一项多中心研究，以检测对急诊科连续718例出现急性心肌梗死症状的患者采集的血样进行新型、敏感心肌肌钙蛋白检测的诊断准确性。采用四种敏感检测方法（雅培Architect肌钙蛋白I、罗氏高敏肌钙蛋白T、罗氏肌钙蛋白I和西门子肌钙蛋白I超敏检测）和一种标准检测方法（罗氏肌钙蛋白T）以盲法测定心肌肌钙蛋白水平。最终诊断由两名独立的心脏病专家判定。
123例患者（17%）的最终诊断判定为急性心肌梗死。用接受者操作特征曲线下面积（AUC）量化的就诊时检测结果的诊断准确性，四种敏感心肌肌钙蛋白检测方法显著高于标准检测方法（雅培Architect肌钙蛋白I的AUC为0.96；95%置信区间[CI]，0.94至0.98；罗氏高敏肌钙蛋白T的AUC为0.96；95%CI，0.94至0.98；罗氏肌钙蛋白I的AUC为0.95；95%CI，0.92至0.97；西门子肌钙蛋白I超敏检测的AUC为0.96；95%CI，0.94至0.98；相比之下，标准检测方法的AUC为0.90；95%CI，0.86至0.94）。在胸痛发作后3小时内就诊的患者中，敏感检测方法的AUC分别为0.93（95%CI，0.88至0.99）､0.92（95%CI，0.87至0.97）､0.92（95%CI，0.86至0.99）和0.94（95%CI，0.90至0.98），标准检测方法的AUC为0.76（95%CI，0.64至0.88）。我们未评估敏感肌钙蛋白检测方法对临床管理的影响。
敏感心肌肌钙蛋白检测方法的诊断性能优异，这些检测方法可显著改善急性心肌梗死的早期诊断，尤其是近期出现胸痛的患者。（ClinicalTrials.gov编号，NCT00470587。）
