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前瞻性随机化临床试验:紧急心脏计算机断层扫描(PROTECCT)。

Prospective RandOmised Trial of Emergency Cardiac Computerised Tomography (PROTECCT).

机构信息

School of Biomedical Engineering and Imaging Sciences, Faculty of Life Sciences & Medicine, King's College London, London, UK.

British Heart Foundation Centre of Excellence and NIHR Biomedical Research Centre at the School of Cardiovascular Medicine and Sciences, King's College London, London, UK.

出版信息

Heart. 2022 Nov 24;108(24):1972-1978. doi: 10.1136/heartjnl-2022-320990.

DOI:10.1136/heartjnl-2022-320990
PMID:36288924
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9726962/
Abstract

OBJECTIVE

Many patients presenting with suspected acute coronary syndrome (ACS) have high-sensitivity cardiac troponin (hs-cTn) concentrations between rule-in and rule-out thresholds and hence need serial testing, which is time consuming. The Prospective RandOmised Trial of Emergency Cardiac Computerised Tomography (PROTECCT) assessed the utility of coronary CT angiography (CCTA) in patients with suspected ACS, non-ischaemic ECG and intermediate initial hs-cTn concentration.

METHODS

Patients were randomised to CCTA-guided management versus standard of care (SOC). The primary outcome was hospital length of stay (LOS). Secondary outcomes included cost of in-hospital stay and major adverse cardiac events (MACE) at 12 months of follow-up. Data are mean (SD); for LOS harmonic means, IQRs are shown.

RESULTS

250 (aged 55 (14) years, 25% women) patients were randomised. Harmonic mean (IQR) LOS was 7.53 (6.0-9.6) hours in the CCTA arm and 8.14 (6.3-9.8) hours in the SOC arm (p=0.13). Inpatient cost was £1285 (£2216) and £1108 (£3573), respectively, p=0.68. LOS was shorter in the CCTA group in patients with <25% stenosis, compared with SOC; 6.6 (5.6-7.8) hours vs 7.5 (6.1-9.4) hours, respectively; p=0.021. More referrals for cardiology outpatient clinic review and cardiac CT-related outpatient referrals occurred in the SOC arm (p=0.01). 12-month MACE rates were similar between the two arms (7 (5.6%) in the CCTA arm and 8 (6.5%) in the SOC arm-log-rank p=0.78).

CONCLUSIONS

CCTA did not lead to reduced hospital LOS or cost, largely because these outcomes were influenced by the detection of ≥25% grade stenosis in a proportion of patients.

TRIAL REGISTRATION NUMBER

NCT03583320.

摘要

目的

许多疑似急性冠状动脉综合征(ACS)的患者 hs-cTn 浓度在纳入和排除标准之间,因此需要进行连续检测,这很耗时。前瞻性随机急性心肌计算机断层扫描(PROTECCT)试验评估了冠状动脉 CT 血管造影(CCTA)在疑似 ACS、非缺血性心电图和初始 hs-cTn 浓度中等的患者中的应用。

方法

患者被随机分配到 CCTA 指导管理与标准护理(SOC)。主要结局是住院时间(LOS)。次要结局包括住院期间的成本和 12 个月随访时的主要不良心脏事件(MACE)。数据为平均值(标准差);LOS 为调和平均值,IQR 显示。

结果

共随机分配了 250 名(年龄 55(14)岁,25%为女性)患者。CCTA 组的调和平均值(IQR)LOS 为 7.53(6.0-9.6)小时,SOC 组为 8.14(6.3-9.8)小时(p=0.13)。住院费用分别为 1285 英镑(2216 美元)和 1108 英镑(3573 美元),p=0.68。在狭窄程度<25%的患者中,CCTA 组的 LOS 短于 SOC 组;分别为 6.6(5.6-7.8)小时和 7.5(6.1-9.4)小时,p=0.021。SOC 组有更多的患者需要心内科门诊复查和心脏 CT 相关的门诊复查(p=0.01)。两组 12 个月的 MACE 发生率相似(CCTA 组 7(5.6%),SOC 组 8(6.5%)-log-rank p=0.78)。

结论

CCTA 并未导致住院 LOS 或成本降低,这主要是因为这些结果受到一部分患者存在≥25%级狭窄的影响。

试验注册

NCT03583320。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ef92/9726962/2e75c80aa468/heartjnl-2022-320990f02.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ef92/9726962/88ea69f62f48/heartjnl-2022-320990f01.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ef92/9726962/2e75c80aa468/heartjnl-2022-320990f02.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ef92/9726962/88ea69f62f48/heartjnl-2022-320990f01.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ef92/9726962/2e75c80aa468/heartjnl-2022-320990f02.jpg

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