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冠状动脉计算机断层扫描作为疑似冠心病行有创血管造影适应证的稳定型患者一线解剖学检查的价值:CAT-CAD 随机试验。

The value of Coronary Artery computed Tomography as the first-line anatomical test for stable patients with indications for invasive angiography due to suspected Coronary Artery Disease: CAT-CAD randomized trial.

机构信息

Institute of Cardiology in Warsaw, Poland.

Institute of Cardiology in Warsaw, Poland.

出版信息

J Cardiovasc Comput Tomogr. 2018 Nov-Dec;12(6):472-479. doi: 10.1016/j.jcct.2018.08.004. Epub 2018 Sep 4.

Abstract

BACKGROUND

The aim of this prospective, randomized trial was to evaluate whether the use of coronary computed tomography angiography (CCTA) as the first-line anatomical test in patients with suspected significant coronary artery disease (CAD) may reduce the number of coronary invasive angiographies (ICA), and expand the use of CCTA in patients currently diagnosed invasively.

METHODS

120 patients (age:60.6 ± 7.9 years, 35% female) with indications to ICA were randomized 1:1 to undergo CCTA versus direct ICA. Outcomes were evaluated during the diagnostic and therapeutic periods.

RESULTS

The number of invasively examined patients was reduced by 64.4% in the CCTA group as compared to the direct ICA group (21vs59,p < 0.0001). The number of patients with ICAs not followed by coronary intervention was reduced by 88.1% with the CCTA strategy (5vs42,p < 0.0001). Over the diagnostic and therapeutic course there were no significant differences regarding the median volume of contrast (CCTA 80.3 ml[65.0-165.0] vs ICA 90.0 ml[55.0-100.0], p = 0.099), while a non-significant trend towards higher radiation dose in the CCTA group was observed (9.9 mSv[7.0-22.1] vs 9.4 mSv[5.2-14.0], p = 0.05). There were no acute cardiovascular events.

CONCLUSIONS

CCTA may hypothetically act as an effective 'gatekeeper' to the catheterization laboratory in the diagnosis of stable patients with current indications for ICA. This strategy may result in non-invasive, outpatient-based triage of two thirds of individuals without actionable CAD, obviating unnecessary invasive examinations. However, the longer follow-up is indispensable. CLINICALTRIALS.

GOV NUMBER

NCT02591992.

摘要

背景

本前瞻性、随机试验旨在评估疑似严重冠状动脉疾病(CAD)患者中使用冠状动脉计算机断层扫描血管造影(CCTA)作为一线解剖学检查是否可减少冠状动脉介入血管造影(ICA)的数量,并扩大 CCTA 在目前经侵入性诊断的患者中的应用。

方法

120 例有 ICA 适应证的患者(年龄:60.6±7.9 岁,35%为女性)按 1:1 随机分为 CCTA 组或直接 ICA 组。在诊断和治疗期间评估结果。

结果

与直接 ICA 组相比,CCTA 组接受侵入性检查的患者数量减少了 64.4%(21 例比 59 例,p<0.0001)。CCTA 策略使不进行冠状动脉介入的 ICA 患者数量减少了 88.1%(5 例比 42 例,p<0.0001)。在诊断和治疗过程中,两组之间中位数的造影剂体积无显著差异(CCTA 组 80.3ml[65.0-165.0]比 ICA 组 90.0ml[55.0-100.0],p=0.099),但观察到 CCTA 组的辐射剂量呈非显著增高趋势(9.9mSv[7.0-22.1]比 9.4mSv[5.2-14.0],p=0.05)。无急性心血管事件。

结论

CCTA 可能可以作为目前有 ICA 适应证的稳定型患者进入导管室的有效“守门员”。该策略可能会导致三分之二无可操作 CAD 的患者无需进行不必要的侵入性检查,从而进行非侵入性、门诊基础的分诊。然而,更长时间的随访是不可或缺的。临床试验。

注册号

NCT02591992。

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