Cardiovascular Sciences, The University of Manchester, Manchester, UK.
Emergency Department, Central Manchester University Hospitals Foundation NHS Trust, Manchester, UK.
Emerg Med J. 2017 Sep;34(9):586-592. doi: 10.1136/emermed-2016-206148. Epub 2017 May 12.
Observational studies suggest that the Manchester Acute Coronary Syndromes (MACS) decision rule can effectively 'rule out' and 'rule in' acute coronary syndromes (ACS) following a single blood test. In a pilot randomised controlled trial, we aimed to determine whether a large trial is feasible.
Patients presenting to two EDs with suspected cardiac chest pain were randomised to receive care guided by the MACS decision rule (intervention group) or standard care (controls). The primary efficacy outcome was a successful discharge from the ED, defined as a decision to discharge within 4 hours of arrival providing that the patient did not have a missed acute myocardial infarction (AMI) or develop a major adverse cardiac event (MACE: death, AMI or coronary revascularisation) within 30 days. Feasibility outcomes included recruitment and attrition rates.
In total, 138 patients were included between October 2013 and October 2014, of whom 131 (95%) were randomised (66 to intervention and 65 controls). Nine (7%) patients had prevalent AMI and six (5%) had incident MACE within 30 days. All 131 patients completed 30-day follow-up and were included in the final analysis with no missing data for the primary analyses. Compared with standard care, a significantly greater proportion of patients whose care was guided by the MACS rule were successfully discharged within 4 hours (26% vs 8%, adjusted OR 5.45, 95% CI 1.73 to 17.11, p=0.004). No patients in either group who were discharged within 4 hours had a diagnosis of AMI or incident MACE within 30 days (0.0%, 95% CI 0% to 20.0% in the intervention group).
In this pilot trial, use of the MACS rule led to a significant increase in safe discharges from the ED but a larger, fully powered trial remains necessary. Our findings seem to support the feasibility of that trial.
ISRCTN 86818215.
13/NW/0081.
观察性研究表明，曼彻斯特急性冠状动脉综合征（MACS）决策规则可通过单次血液检查有效“排除”和“确诊”急性冠状动脉综合征（ACS）。在一项小型随机对照试验中，我们旨在确定是否可行开展大型试验。
将疑似心前区胸痛就诊于两家急诊的患者随机分配至接受 MACS 决策规则指导的治疗（干预组）或标准治疗（对照组）。主要疗效结局为急诊科成功出院，定义为患者在抵达后 4 小时内决定出院，前提是患者没有错过急性心肌梗死（AMI）或在 30 天内没有发生主要不良心脏事件（MACE：死亡、AMI 或冠状动脉血运重建）。可行性结局包括入组和失访率。
2013 年 10 月至 2014 年 10 月期间共纳入 138 例患者，其中 131 例（95%）随机分配（干预组 66 例，对照组 65 例）。9 例（7%）患者存在既往性 AMI，6 例（5%）患者在 30 天内发生新发 MACE。所有 131 例患者均完成 30 天随访，最终分析纳入 131 例患者，无主要分析缺失数据。与标准治疗相比，接受 MACS 规则指导的患者在 4 小时内成功出院的比例显著更高（26% vs 8%，校正 OR 5.45，95%CI 1.73 至 17.11，p=0.004）。两组中在 4 小时内出院的患者在 30 天内均无 AMI 或新发 MACE 诊断（干预组为 0.0%，95%CI 0%至 20.0%）。
在这项小型试验中，MACS 规则的使用显著增加了急诊科安全出院的比例，但仍需要开展更大规模、更全面的试验。我们的研究结果似乎支持该试验的可行性。
ISRCTN86818215。
13/NW/0081。
14334。
