High-Sensitivity Cardiac Troponin on Presentation to Rule Out Myocardial Infarction: A Stepped-Wedge Cluster Randomized Controlled Trial.
High-Sensitivity Cardiac Troponin on Presentation to Rule Out Myocardial Infarction: A Stepped-Wedge Cluster Randomized Controlled Trial.
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DOI：
10.1161/circulationaha.120.052380
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发表时间：
2021-06-08
期刊：
影响因子：
37.8
通讯作者：
HiSTORIC Investigators†
中科院分区：
文献类型：
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作者：
Anand A;Lee KK;Chapman AR;Ferry AV;Adamson PD;Strachan FE;Berry C;Findlay I;Cruikshank A;Reid A;Collinson PO;Apple FS;McAllister DA;Maguire D;Fox KAA;Newby DE;Tuck C;Harkess R;Keerie C;Weir CJ;Parker RA;Gray A;Shah ASV;Mills NL;HiSTORIC Investigators†
补充数字内容可在文本中找到。高灵敏度的心肌肌钙蛋白检测可以更早地排除心肌梗死，但这种方法的安全性和有效性尚不确定。我们研究了早期排除途径对疑似急性冠状动脉综合征患者是否安全有效。我们在苏格兰7家急诊医院的急诊科进行了一项阶梯楔形分组随机对照试验。纳入了2014年12月至2016年12月期间疑似急性冠状动脉综合征的连续患者。研究中心被随机分配实施早期排除途径，如果就诊时高敏心肌肌钙蛋白I浓度<5 ng/L，则排除心肌梗死。在先前的验证阶段，当症状发作后6至12小时肌钙蛋白浓度<第99百分位数时，排除心肌梗死。共同主要结局为住院时间（疗效）和出院后30天心肌梗死或心源性死亡（安全性）。患者随访1年，以评估安全性和其他次要结局。我们招募了31492例肌钙蛋白浓度<第99百分位数的患者（59±17岁[平均值±标准差]; 45%为女性）。实施后，住院时间从10.1±4.1小时减少到6.8±3.9小时（校正的几何均值比，0.78 [95%CI，0.73-0.83]; P<0.001），出院患者比例从50%增加到71%（校正的比值比，1.59 [95%CI，1.45-1.75]）。未证明30天安全性结局的非劣效性（校正风险差异的单侧95% CI上限为0.70% [非劣效性界值0.50%]; P=0.068），但观察到的差异有利于早期排除途径（0.4% [57/14 700] vs 0.3% [56/16 792]）。在1年时，实施前和实施后分别有2.7%（396/14700）和1.8%（307/16792）的患者发生安全性结局（调整后的比值比，1.02 [95%CI，0.74-1.40]; P=0.894），住院再访或全因死亡率无差异。实施心肌梗死早期排除途径可缩短住院时间和住院时间。尽管30天时未证明安全性结局的非劣效性，但1年时心脏事件未增加。采用这一途径将对患者和卫生保健提供者产生重大益处。URL：https://www.clinicaltrials.gov;唯一标识符：NCT 03005158。
Supplemental Digital Content is available in the text. High-sensitivity cardiac troponin assays enable myocardial infarction to be ruled out earlier, but the safety and efficacy of this approach is uncertain. We investigated whether an early rule-out pathway is safe and effective for patients with suspected acute coronary syndrome. We performed a stepped-wedge cluster randomized controlled trial in the emergency departments of 7 acute care hospitals in Scotland. Consecutive patients presenting with suspected acute coronary syndrome between December 2014 and December 2016 were included. Sites were randomized to implement an early rule-out pathway where myocardial infarction was excluded if high-sensitivity cardiac troponin I concentrations were <5 ng/L at presentation. During a previous validation phase, myocardial infarction was ruled out when troponin concentrations were <99th percentile at 6 to 12 hours after symptom onset. The coprimary outcome was length of stay (efficacy) and myocardial infarction or cardiac death after discharge at 30 days (safety). Patients were followed for 1 year to evaluate safety and other secondary outcomes. We enrolled 31 492 patients (59±17 years of age [mean±SD]; 45% women) with troponin concentrations <99th percentile at presentation. Length of stay was reduced from 10.1±4.1 to 6.8±3.9 hours (adjusted geometric mean ratio, 0.78 [95% CI, 0.73–0.83]; P<0.001) after implementation and the proportion of patients discharged increased from 50% to 71% (adjusted odds ratio, 1.59 [95% CI, 1.45–1.75]). Noninferiority was not demonstrated for the 30-day safety outcome (upper limit of 1-sided 95% CI for adjusted risk difference, 0.70% [noninferiority margin 0.50%]; P=0.068), but the observed differences favored the early rule-out pathway (0.4% [57/14 700] versus 0.3% [56/16 792]). At 1 year, the safety outcome occurred in 2.7% (396/14 700) and 1.8% (307/16 792) of patients before and after implementation (adjusted odds ratio, 1.02 [95% CI, 0.74–1.40]; P=0.894), and there were no differences in hospital reattendance or all-cause mortality. Implementation of an early rule-out pathway for myocardial infarction reduced length of stay and hospital admission. Although noninferiority for the safety outcome was not demonstrated at 30 days, there was no increase in cardiac events at 1 year. Adoption of this pathway would have major benefits for patients and health care providers. URL: https://www.clinicaltrials.gov; Unique identifier: NCT03005158.