BHF Centre for Cardiovascular Science (A.A., K.K.L., A.R.C., A.V.F., P.D.A., F.E.S., K.A.A.F., D.E.N., A.S.V.S., N.L.M.), University of Edinburgh, United Kingdom.s.
Christchurch Heart Institute, University of Otago, Christchurch, New Zealand (P.D.A.).
Circulation. 2021 Jun 8;143(23):2214-2224. doi: 10.1161/CIRCULATIONAHA.120.052380. Epub 2021 Mar 23.
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]; <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%]; =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]; =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. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03005158.
高敏心肌肌钙蛋白检测可更早排除心肌梗死，但这种方法的安全性和有效性尚不确定。我们研究了对于疑似急性冠状动脉综合征患者，早期排除途径是否安全有效。
我们在苏格兰 7 家急症护理医院的急诊科进行了一项阶梯式楔形集群随机对照试验。2014 年 12 月至 2016 年 12 月期间连续纳入疑似急性冠状动脉综合征患者。各地点被随机分配实施早期排除途径，如果高敏心肌肌钙蛋白 I 浓度在就诊时<5ng/L，则排除心肌梗死。在之前的验证阶段，当肌钙蛋白浓度在症状发作后 6 至 12 小时<99 百分位时，排除心肌梗死。主要复合结局为出院后 30 天的住院时间（疗效）和心肌梗死或心脏性死亡（安全性）。患者随访 1 年以评估安全性和其他次要结局。
我们纳入了 31492 名患者（年龄 59±17 岁[均数±标准差]；45%为女性），就诊时肌钙蛋白浓度<99 百分位。实施后住院时间从 10.1±4.1 小时缩短至 6.8±3.9 小时（调整后的几何均数比值，0.78[95%CI，0.73-0.83]；<0.001），出院患者比例从 50%增加到 71%（调整后的优势比，1.59[95%CI，1.45-1.75]）。30 天安全性结局未显示非劣效性（调整风险差异单侧 95%CI 上限，0.70%[非劣效性边界 0.50%]；=0.068），但观察到的差异有利于早期排除途径（0.4%[57/14700]与 0.3%[56/16792]）。1 年后，安全性结局在实施前后分别发生在 2.7%（396/14700）和 1.8%（307/16792）的患者中（调整后的优势比，1.02[95%CI，0.74-1.40]；=0.894），且在医院再入院或全因死亡率方面无差异。
实施心肌梗死的早期排除途径可缩短住院时间和入院率。尽管 30 天时未显示安全性结局非劣效性，但 1 年后心脏事件无增加。采用这种途径将给患者和医疗保健提供者带来重大益处。
Zotero 插件
