High-sensitivity troponin in the evaluation of patients with suspected acute coronary syndrome: a stepped-wedge, cluster-randomised controlled trial.
High-sensitivity troponin in the evaluation of patients with suspected acute coronary syndrome: a stepped-wedge, cluster-randomised controlled trial.
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DOI：
10.1016/s0140-6736(18)31923-8
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发表时间：
2018-09-15
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通讯作者：
High-STEACS Investigators
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作者：
Shah ASV;Anand A;Strachan FE;Ferry AV;Lee KK;Chapman AR;Sandeman D;Stables CL;Adamson PD;Andrews JPM;Anwar MS;Hung J;Moss AJ;O'Brien R;Berry C;Findlay I;Walker S;Cruickshank A;Reid A;Gray A;Collinson PO;Apple FS;McAllister DA;Maguire D;Fox KAA;Newby DE;Tuck C;Harkess R;Parker RA;Keerie C;Weir CJ;Mills NL;High-STEACS Investigators
高灵敏度心肌肌钙蛋白检测允许使用较低的阈值诊断心肌梗死，但这是否改善临床结局尚不清楚。我们的目的是确定是否引入高灵敏度心肌肌钙蛋白I（hs-cTnI）检测与性别特异性第99百分位数的诊断阈值将减少随后的心肌梗死或心血管死亡的疑似急性冠状动脉综合征患者。在这项跨越苏格兰10家二级或三级护理医院的阶梯楔形、随机分组对照试验中，我们评估了hs-cTnI检测在因疑似急性冠脉综合征而被医院急诊科收治的连续患者中的实施。如果患者出现疑似急性冠状动脉综合征，并且通过标准治疗和试验检测进行了成对的心肌肌钙蛋白测量，则有资格入选。在6-12个月的验证阶段，hs-cTnI检测的结果对主治临床医生隐瞒，并使用当代心肌肌钙蛋白I（cTnI）检测来指导护理。医院被随机分配到早期（n=5家医院）或晚期（n=5家医院）实施，其中高灵敏度检测和性别特异性第99百分位数诊断阈值在6个月验证阶段后立即引入或再推迟6个月。通过高灵敏度检测重新分类的患者定义为hs-cTnI浓度升高且cTnI浓度低于当前检测诊断阈值的患者。主要结局是首次就诊后1年时发生心肌梗死或心血管原因导致的死亡。结果进行了比较的患者重新分类的高灵敏度检测之前和之后，其实施使用调整广义线性混合模型。本试验在ClinicalTrials.gov注册，编号为NCT 01852123。在2013年6月10日至2016年3月3日期间，我们入组了48282例连续患者（61 [SD 17]岁，47%为女性），其中10360例（21%）患者的cTnI浓度大于正常值范围的第99百分位数，这些患者通过当代检测或高灵敏度检测确定。 高灵敏度检测对10360例心肌损伤或梗死患者中的1771例（17%）进行了重新分类，这些患者未被当代检测确定。 在重新分类的患者中，验证阶段720例患者中有105例（15%）在1年内发生了随后的心肌梗死或心血管死亡，实施阶段1051例患者中有131例（12%）发生了随后的心肌梗死或心血管死亡（实施阶段与验证阶段的校正比值比为1·10，95% CI为0·75至1·61; p=0·620）。使用高灵敏度检测促使10360例心肌损伤或梗死患者中的1771例（17%）重新分类，但与1年时心肌梗死或心血管死亡的后续发生率较低无关。 我们的研究结果质疑心肌梗死的诊断阈值是否应该基于正常参考人群的第99百分位数。英国心脏基金会
High-sensitivity cardiac troponin assays permit use of lower thresholds for the diagnosis of myocardial infarction, but whether this improves clinical outcomes is unknown. We aimed to determine whether the introduction of a high-sensitivity cardiac troponin I (hs-cTnI) assay with a sex-specific 99th centile diagnostic threshold would reduce subsequent myocardial infarction or cardiovascular death in patients with suspected acute coronary syndrome. In this stepped-wedge, cluster-randomised controlled trial across ten secondary or tertiary care hospitals in Scotland, we evaluated the implementation of an hs-cTnI assay in consecutive patients who had been admitted to the hospitals' emergency departments with suspected acute coronary syndrome. Patients were eligible for inclusion if they presented with suspected acute coronary syndrome and had paired cardiac troponin measurements from the standard care and trial assays. During a validation phase of 6–12 months, results from the hs-cTnI assay were concealed from the attending clinician, and a contemporary cardiac troponin I (cTnI) assay was used to guide care. Hospitals were randomly allocated to early (n=5 hospitals) or late (n=5 hospitals) implementation, in which the high-sensitivity assay and sex-specific 99th centile diagnostic threshold was introduced immediately after the 6-month validation phase or was deferred for a further 6 months. Patients reclassified by the high-sensitivity assay were defined as those with an increased hs-cTnI concentration in whom cTnI concentrations were below the diagnostic threshold on the contemporary assay. The primary outcome was subsequent myocardial infarction or death from cardiovascular causes at 1 year after initial presentation. Outcomes were compared in patients reclassified by the high-sensitivity assay before and after its implementation by use of an adjusted generalised linear mixed model. This trial is registered with ClinicalTrials.gov, number NCT01852123. Between June 10, 2013, and March 3, 2016, we enrolled 48 282 consecutive patients (61 [SD 17] years, 47% women) of whom 10 360 (21%) patients had cTnI concentrations greater than those of the 99th centile of the normal range of values, who were identified by the contemporary assay or the high-sensitivity assay. The high-sensitivity assay reclassified 1771 (17%) of 10 360 patients with myocardial injury or infarction who were not identified by the contemporary assay. In those reclassified, subsequent myocardial infarction or cardiovascular death within 1 year occurred in 105 (15%) of 720 patients in the validation phase and 131 (12%) of 1051 patients in the implementation phase (adjusted odds ratio for implementation vs validation phase 1·10, 95% CI 0·75 to 1·61; p=0·620). Use of a high-sensitivity assay prompted reclassification of 1771 (17%) of 10 360 patients with myocardial injury or infarction, but was not associated with a lower subsequent incidence of myocardial infarction or cardiovascular death at 1 year. Our findings question whether the diagnostic threshold for myocardial infarction should be based on the 99th centile derived from a normal reference population. The British Heart Foundation.