From Cardiovascular Research Institute Basel and Department of Cardiology, University Hospital Basel, University of Basel, Switzerland (J.B., T.N., R.T., K.W., P.B., J.C., T.B., P.M., S.C., K.G., M.R.G., C.P., S.S., D.F.W., J.F., P.H., Z.S., U.H., N.S., N.K., J.L. W.K., S.O., T.R., C.M.); Department of Internal Medicine, University Hospital Basel, University of Basel, Switzerland (J.B., T.N., K.G., P.H., N.S.); GREAT Network (J.B., T.N., R.T., K.W., P.B., J.C., S.C., K.G., M.R.G., C.P., S.S., D.F.W., P.H., Z.S., U.H., N.S., N.K., O.M., B.L., E.G., J.P., T.R., C.M.); Emergency Department, University Hospital Zurich, Switzerland (T.B., P.M., D.I.K.); Laboratory Medicine, University Hospital Basel, Switzerland (K.R.); Emergency Department, Hospital Clinic, Barcelona, Catalonia, Spain (O.M., B.L.); Servicio de Urgencias, Hospital Clínico San Carlos, Madrid, Spain (F.J.M.-S., E.R.-A.); 2nd Department of Cardiology, Medical University of Silesia, Zabrze, Poland (B.M., D.K.); Department of Cardiology, University Hospital Brno, Czech Republic and Medical Faculty, Masaryk University (E.G., J.P.); Blood Transfusion Centre, Swiss Red Cross, Basel, Switzerland and Department of Hematology, University Hospital Basel (A.B.); and Emergency Department, Kantonsspital Liestal, Switzerland (N.G.).
Circulation. 2017 Apr 25;135(17):1597-1611. doi: 10.1161/CIRCULATIONAHA.116.025661. Epub 2017 Mar 10.
Four strategies for very early rule-out of acute myocardial infarction using high-sensitivity cardiac troponin I (hs-cTnI) have been identified. It remains unclear which strategy is most attractive for clinical application.
We prospectively enrolled unselected patients presenting to the emergency department with symptoms suggestive of acute myocardial infarction. The final diagnosis was adjudicated by 2 independent cardiologists. Hs-cTnI levels were measured at presentation and after 1 hour in a blinded fashion. We directly compared all 4 hs-cTnI-based rule-out strategies: limit of detection (LOD, hs-cTnI<2 ng/L), single cutoff (hs-cTnI<5 ng/L), 1-hour algorithm (hs-cTnI<5 ng/L and 1-hour change<2 ng/L), and the 0/1-hour algorithm recommended in the European Society of Cardiology guideline combining LOD and 1-hour algorithm.
Among 2828 enrolled patients, acute myocardial infarction was the final diagnosis in 451 (16%) patients. The LOD approach ruled out 453 patients (16%) with a sensitivity of 100% (95% confidence interval [CI], 99.2%-100%), the single cutoff 1516 patients (54%) with a sensitivity of 97.1% (95% CI, 95.1%-98.3%), the 1-hour algorithm 1459 patients (52%) with a sensitivity of 98.4% (95% CI, 96.8%-99.2%), and the 0/1-hour algorithm 1463 patients (52%) with a sensitivity of 98.4% (95% CI, 96.8%-99.2%). Predefined subgroup analysis in early presenters (≤2 hours) revealed significantly lower sensitivity (94.2%, interaction =0.03) of the single cutoff, but not the other strategies. Two-year survival was 100% with LOD and 98.1% with the other strategies (<0.01 for LOD versus each of the other strategies).
All 4 rule-out strategies balance effectiveness and safety equally well. The single cutoff should not be applied in early presenters, whereas the 3 other strategies seem to perform well in this challenging subgroup.
URL: http://www.clinicaltrials.gov. Unique identifier: NCT00470587.
已经确定了使用高敏心肌肌钙蛋白 I（hs-cTnI）对急性心肌梗死进行极早期排除的 4 种策略。目前尚不清楚哪种策略最适合临床应用。
我们前瞻性纳入了因疑似急性心肌梗死而就诊于急诊科的未经选择的患者。最终诊断由 2 位独立的心脏病专家进行裁决。hs-cTnI 水平在就诊时和 1 小时后以盲法进行测量。我们直接比较了所有 4 种基于 hs-cTnI 的排除策略：检测限（hs-cTnI<2ng/L）、单截止值（hs-cTnI<5ng/L）、1 小时算法（hs-cTnI<5ng/L 且 1 小时变化值<2ng/L）和欧洲心脏病学会指南中推荐的结合检测限和 1 小时算法的 0/1 小时算法。
在纳入的 2828 例患者中，急性心肌梗死为 451 例（16%）患者的最终诊断。LOD 方法排除了 453 例（16%）患者，其敏感性为 100%（95%可信区间[CI]，99.2%-100%），单截止值排除了 1516 例（54%）患者，敏感性为 97.1%（95%CI，95.1%-98.3%），1 小时算法排除了 1459 例（52%）患者，敏感性为 98.4%（95%CI，96.8%-99.2%），0/1 小时算法排除了 1463 例（52%）患者，敏感性为 98.4%（95%CI，96.8%-99.2%）。在早期就诊者（≤2 小时）的预设亚组分析中，单截止值的敏感性显著降低（94.2%，交互作用=0.03），但其他策略并非如此。LOD 和其他策略的 2 年生存率分别为 100%和 98.1%（LOD 与其他策略相比，P<0.01）。
所有 4 种排除策略在有效性和安全性方面均平衡良好。单截止值不应在早期就诊者中使用，而其他 3 种策略在具有挑战性的亚组中似乎表现良好。
