Usher Institute, University of Edinburgh, Edinburgh, UK.
Department of Emergency Medicine, Royal Infirmary of Edinburgh, Edinburgh, UK.
Health Technol Assess. 2022 Aug;26(37):1-114. doi: 10.3310/IRWI5180.
Acute coronary syndrome is a common medical emergency. The optimal strategy to investigate patients who are at intermediate risk of acute coronary syndrome has not been fully determined.
To investigate the role of early computed tomography coronary angiography in the investigation and treatment of adults presenting with suspected acute coronary syndrome.
A prospective, multicentre, open, parallel-group randomised controlled trial with blinded end-point adjudication.
Thirty-seven hospitals in the UK.
Adults (aged ≥ 18 years) presenting to the emergency department, acute medicine services or cardiology department with suspected or provisionally diagnosed acute coronary syndrome and at least one of the following: (1) a prior history of coronary artery disease, (2) a cardiac troponin level > 99th centile and (3) an abnormal 12-lead electrocardiogram.
Early computed tomography coronary angiography in addition to standard care was compared with standard care alone. Participants were followed up for 1 year.
One-year all-cause death or subsequent type 1 (spontaneous) or type 4b (stent thrombosis) myocardial infarction, measured as the time to such event adjudicated by two cardiologists blinded to the computerised tomography coronary angiography ( CTCA ) arm. Cost-effectiveness was estimated as the lifetime incremental cost per quality-adjusted life-year gained.
Between 23 March 2015 and 27 June 2019, 1748 participants [mean age 62 years (standard deviation 13 years), 64% male, mean Global Registry Of Acute Coronary Events score 115 (standard deviation 35)] were randomised to receive early computed tomography coronary angiography ( = 877) or standard care alone ( = 871). The primary end point occurred in 51 (5.8%) participants randomised to receive computed tomography coronary angiography and 53 (6.1%) participants randomised to receive standard care (adjusted hazard ratio 0.91, 95% confidence interval 0.62 to 1.35; = 0.65). Computed tomography coronary angiography was associated with a reduced use of invasive coronary angiography (adjusted hazard ratio 0.81, 95% confidence interval 0.72 to 0.92; = 0.001) but no change in coronary revascularisation (adjusted hazard ratio 1.03, 95% confidence interval 0.87 to 1.21; = 0.76), acute coronary syndrome therapies (adjusted odds ratio 1.06, 95% confidence interval 0.85 to 1.32; = 0.63) or preventative therapies on discharge (adjusted odds ratio 1.07, 95% confidence interval 0.87 to 1.32; = 0.52). Early computed tomography coronary angiography was associated with longer hospitalisations (median increase 0.21 days, 95% confidence interval 0.05 to 0.40 days) and higher mean total health-care costs over 1 year (£561 more per patient) than standard care.
The principal limitation of the trial was the slower than anticipated recruitment, leading to a revised sample size, and the requirement to compromise and accept a larger relative effect size estimate for the trial intervention.
The potential role of computed tomography coronary angiography in selected patients with a low probability of obstructive coronary artery disease (intermediate or mildly elevated level of troponin) or who have limited access to invasive cardiac catheterisation facilities needs further prospective evaluation.
In patients with suspected or provisionally diagnosed acute coronary syndrome, computed tomography coronary angiography did not alter overall coronary therapeutic interventions or 1-year clinical outcomes, but it did increase the length of hospital stay and health-care costs. These findings do not support the routine use of early computed tomography coronary angiography in intermediate-risk patients with acute chest pain.
This trial is registered as ISRCTN19102565 and Clinical Trials NCT02284191.
This project was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme and will be published in full in ; Vol. 26, No. 37. See the NIHR Journals Library website for further project information.
急性冠状动脉综合征是一种常见的医学急症。对于处于急性冠状动脉综合征中危风险的患者，最佳的检查策略尚未完全确定。
探讨早期计算机断层冠状动脉成像在疑似急性冠状动脉综合征成人患者的检查和治疗中的作用。
一项前瞻性、多中心、开放、平行组随机对照试验，终点裁决设盲。
英国 37 家医院。
疑似或临时诊断为急性冠状动脉综合征且至少存在以下一项的成年人（年龄≥18 岁）：（1）既往有冠状动脉疾病史，（2）心脏肌钙蛋白水平>99 百分位，（3）12 导联心电图异常。
在标准治疗的基础上，早期进行计算机断层冠状动脉成像与单独标准治疗进行比较。参与者随访 1 年。
由两位对计算机断层冠状动脉成像（CTCA）臂不知情的心脏病专家判定的 1 年全因死亡或随后的 1 型（自发性）或 4b 型（支架血栓形成）心肌梗死，为事件发生时间。估计成本效益为获得的每质量调整生命年的终生增量成本。
2015 年 3 月 23 日至 2019 年 6 月 27 日，纳入了 1748 名参与者（平均年龄 62 岁[标准差 13 岁]，64%为男性，平均全球急性冠状动脉事件登记评分 115[标准差 35]），随机分为接受早期计算机断层冠状动脉成像（n=877）或单独标准治疗（n=871）组。主要终点在接受计算机断层冠状动脉成像的 51 名（5.8%）参与者和接受标准治疗的 53 名（6.1%）参与者中发生（校正风险比 0.91，95%置信区间 0.62 至 1.35；P=0.65）。计算机断层冠状动脉成像与侵入性冠状动脉血管造影的使用减少相关（校正风险比 0.81，95%置信区间 0.72 至 0.92；P=0.001），但冠状动脉血运重建无变化（校正风险比 1.03，95%置信区间 0.87 至 1.21；P=0.76）、急性冠状动脉综合征治疗（校正优势比 1.06，95%置信区间 0.85 至 1.32；P=0.63）或出院时预防性治疗（校正优势比 1.07，95%置信区间 0.87 至 1.32；P=0.52）。与标准治疗相比，早期计算机断层冠状动脉成像与更长的住院时间（中位数增加 0.21 天，95%置信区间 0.05 至 0.40 天）和 1 年内更高的平均总医疗保健费用（每位患者增加 561 英镑）相关。
该试验的主要局限性是预期的招募速度较慢，导致修订了样本量，并且需要妥协并接受试验干预的更大相对效果估计值。
在疑似或临时诊断为急性冠状动脉综合征且存在阻塞性冠状动脉疾病低概率（中间或轻度升高的肌钙蛋白水平）或无法获得侵入性心脏导管插入术设施的患者中，计算机断层冠状动脉成像的潜在作用需要进一步前瞻性评估。
在疑似或临时诊断为急性冠状动脉综合征的患者中，计算机断层冠状动脉成像并未改变整体冠状动脉治疗干预措施或 1 年临床结局，但确实增加了住院时间和医疗保健费用。这些发现不支持在急性胸痛的中危风险患者中常规使用早期计算机断层冠状动脉成像。
本试验在 ISRCTN 注册，注册号为 ISRCTN83126334；同时在 ClinicalTrials.gov 注册，注册号为 NCT02284191。
该项目由英国国家卫生与保健研究所（NIHR）卫生技术评估计划资助，将全文在；第 26 卷，第 37 期。有关该项目的更多信息，请访问 NIHR 期刊库网站。
