Wildi Karin, Gimenez Maria Rubini, Twerenbold Raphael, Reichlin Tobias, Jaeger Cedric, Heinzelmann Amely, Arnold Christiane, Nelles Berit, Druey Sophie, Haaf Philip, Hillinger Petra, Schaerli Nicolas, Kreutzinger Philipp, Tanglay Yunus, Herrmann Thomas, Moreno Weidmann Zoraida, Krivoshei Lian, Freese Michael, Stelzig Claudia, Puelacher Christian, Rentsch Katharina, Osswald Stefan, Mueller Christian
From Department of Cardiology and Cardiovascular Research Institute Basel (K.W., M.R.G., R.T., T.R., C.J., A.H., S.D., P.H., P.H., N.S., P.K., Y.T., T.H., Z.M.W., L.K., M.F., C.S., C.P., S.O., C.M.) and Laboratory Medicine (K.R.), University Hospital Basel, Switzerland; Servicio de Urgencias y Pneumologia, CIBERES ISC III, Hospital del Mar-Institut Municipal d'Investigació Mèdica, Barcelona, Spain (M.R.G.); and Department of Internal Medicine, Kantonsspital Olten, Switzerland (C.A.).
Circulation. 2015 Jun 9;131(23):2032-40. doi: 10.1161/CIRCULATIONAHA.114.014129. Epub 2015 May 6.
Misdiagnosis of acute myocardial infarction (AMI) may significantly harm patients and may result from inappropriate clinical decision values (CDVs) for cardiac troponin (cTn) owing to limitations in the current regulatory process.
In an international, prospective, multicenter study, we quantified the incidence of inconsistencies in the diagnosis of AMI using fully characterized and clinically available high-sensitivity (hs) cTn assays (hs-cTnI, Abbott; hs-cTnT, Roche) among 2300 consecutive patients with suspected AMI. We hypothesized that the approved CDVs for the 2 assays are not biologically equivalent and might therefore contribute to inconsistencies in the diagnosis of AMI. Findings were validated by use of sex-specific CDVs and parallel measurements of other hs-cTnI assays. AMI was the adjudicated diagnosis in 473 patients (21%). Among these, 86 patients (18.2%) had inconsistent diagnoses when the approved uniform CDV was used. When sex-specific CDVs were used, 14.1% of female and 22.7% of male AMI patients had inconsistent diagnoses. Using biologically equivalent CDV reduced inconsistencies to 10% (P<0.001). These findings were confirmed with parallel measurements of other hs-cTn assays. The incidence of inconsistencies was only 7.0% for assays with CDVs that were nearly biologically equivalent. Patients with inconsistent AMI had long-term mortality comparable to that of patients with consistent diagnoses (P=NS) and a trend toward higher long-term mortality than patients diagnosed with unstable angina (P=0.05).
Currently approved CDVs are not biologically equivalent and contribute to major inconsistencies in the diagnosis of AMI. One of 5 AMI patients will receive a diagnosis other than AMI if managed with the alternative hs-cTn assay.
URL: http://www.clinicaltrials.gov. Unique identifier: NCT00470587.
急性心肌梗死（AMI）的误诊可能会对患者造成严重伤害，这可能是由于当前监管程序的局限性，导致心脏肌钙蛋白（cTn）的临床决策值（CDV）不恰当所致。
在一项国际、前瞻性、多中心研究中，我们使用充分表征且临床可用的高敏（hs）cTn检测方法（hs-cTnI，雅培公司；hs-cTnT，罗氏公司），对2300例连续疑似AMI患者中AMI诊断不一致的发生率进行了量化。我们假设这两种检测方法的获批CDV在生物学上并不等效，因此可能导致AMI诊断的不一致。通过使用性别特异性CDV和其他hs-cTnI检测方法的平行测量对结果进行了验证。473例患者（21%）的最终诊断为AMI。其中，当使用获批的统一CDV时，86例患者（18.2%）的诊断不一致。当使用性别特异性CDV时，14.1%的女性和22.7%的男性AMI患者诊断不一致。使用生物学等效的CDV可将不一致率降至10%（P<0.001）。其他hs-cTn检测方法的平行测量证实了这些结果。对于CDV在生物学上几乎等效的检测方法，不一致率仅为7.0%。AMI诊断不一致的患者长期死亡率与诊断一致的患者相当（P=无显著性差异），且与诊断为不稳定型心绞痛的患者相比，长期死亡率有升高趋势（P=0.05）。
目前获批的CDV在生物学上并不等效，导致AMI诊断存在重大不一致。如果使用替代的hs-cTn检测方法进行管理，五分之一的AMI患者将得到非AMI的诊断。
