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在一项随机试验中,使用 2016 年英国国家卫生与保健优化研究所指南评估计算机断层冠状动脉成像的诊断和预后效益。

Diagnostic and prognostic benefits of computed tomography coronary angiography using the 2016 National Institute for Health and Care Excellence guidance within a randomised trial.

机构信息

BHF Centre for Cardiovascular Science, University of Edinburgh, Edinburgh, UK.

Edinburgh Imaging, Queens Medical Research Institute, University of Edinburgh, Edinburgh, UK.

出版信息

Heart. 2018 Feb;104(3):207-214. doi: 10.1136/heartjnl-2017-311508. Epub 2017 Aug 27.

Abstract

OBJECTIVES

To evaluate the diagnostic and prognostic benefits of CT coronary angiography (CTCA) using the 2016 National Institute for Health and Care Excellence (NICE) guidelines for the assessment of suspected stable angina.

METHODS

Post hoc analysis of the Scottish COmputed Tomography of the HEART (SCOT-HEART) trial of 4146 participants with suspected angina randomised to CTCA. Patients were dichotomised into NICE guideline-defined possible angina and non-anginal presentations. Primary (diagnostic) endpoint was diagnostic certainty of angina at 6 weeks and prognostic endpoint comprised fatal and non-fatal myocardial infarction (MI).

RESULTS

In 3770 eligible participants, CTCA increased diagnostic certainty more in those with possible angina (relative risk (RR) 2.22 (95% CI 1.91 to 2.60), p<0.001) than those with non-anginal symptoms (RR 1.30 (1.11 to 1.53), p=0.002; p <0.001). In the possible angina cohort, CTCA did not change rates of invasive angiography (p=0.481) but markedly reduced rates of normal coronary angiography (HR 0.32 (0.19 to 0.52), p<0.001). In the non-anginal cohort, rates of invasive angiography increased (HR 1.82 (1.13 to 2.92), p=0.014) without reducing rates of normal coronary angiography (HR 0.78 (0.30 to 2.05), p=0.622). At 3.2 years of follow-up, fatal or non-fatal MI was reduced in patients with possible angina (3.2% to 1.9%%; HR 0.58 (0.34 to 0.99), p=0.045) but not in those with non-anginal symptoms (HR 0.65 (0.25 to 1.69), p=0.379).

CONCLUSIONS

NICE-guided patient selection maximises the benefits of CTCA on diagnostic certainty, use of invasive coronary angiography and reductions in fatal and non-fatal myocardial infarction. Patients with non-anginal chest pain derive minimal benefit from CTCA and increase the rates of invasive investigation.

TRIAL REGISTRATION NUMBER

ClinicalTrials.gov: NCT01149590;post results.

摘要

目的

根据 2016 年英国国家卫生与保健优化研究所(NICE)用于评估疑似稳定性心绞痛的指南,评估 CT 冠状动脉成像(CTCA)的诊断和预后获益。

方法

对苏格兰 CT 心脏研究(SCOT-HEART)试验中 4146 名疑似心绞痛患者的事后分析,这些患者被随机分配至 CTCA。根据 NICE 指南定义,将患者分为可能心绞痛和非心绞痛表现。主要(诊断)终点为 6 周时的心绞痛诊断准确性,预后终点包括致命和非致命性心肌梗死(MI)。

结果

在 3770 名符合条件的患者中,CTCA 在可能心绞痛患者中提高诊断准确性的幅度更大(相对风险(RR)2.22(95%CI 1.91 至 2.60),p<0.001),而非心绞痛症状患者(RR 1.30(1.11 至 1.53),p=0.002;p<0.001)。在可能心绞痛组中,CTCA 并未改变经皮冠状动脉造影术(PCI)的比率(p=0.481),但显著降低了正常冠状动脉造影术的比率(HR 0.32(0.19 至 0.52),p<0.001)。在非心绞痛组中,PCI 比率增加(HR 1.82(1.13 至 2.92),p=0.014),而正常冠状动脉造影术的比率没有降低(HR 0.78(0.30 至 2.05),p=0.622)。在 3.2 年的随访中,可能心绞痛患者的致命或非致命性 MI 减少(3.2%至 1.9%;HR 0.58(0.34 至 0.99),p=0.045),而非心绞痛症状患者则没有(HR 0.65(0.25 至 1.69),p=0.379)。

结论

NICE 指导的患者选择最大限度地提高了 CTCA 在诊断准确性、经皮冠状动脉介入治疗(PCI)的应用以及降低致命性和非致命性心肌梗死方面的获益。非心绞痛胸痛患者从 CTCA 中获益最小,反而增加了有创性检查的比率。

试验注册

ClinicalTrials.gov:NCT01149590;结果公布后注册。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/206e/5861384/8ab153acf808/heartjnl-2017-311508f01.jpg

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