From the University of Edinburgh, Edinburgh (D.E.N., P.D.A., N.A.B., M.R.D., A.H., S.L., N.L.M., J.N., A.S.V.S., E.J.R.B., M.C.W.), the University of Glasgow, Glasgow (C.B., G.R.), the University of East Anglia, Norwich (M.F.), NHS Fife, Kirkcaldy (S.M.), and Queen Mary University, London (A.D.T.) - all in the United Kingdom; and the University of Limerick, Limerick, Ireland (J.F.).
N Engl J Med. 2018 Sep 6;379(10):924-933. doi: 10.1056/NEJMoa1805971. Epub 2018 Aug 25.
Although coronary computed tomographic angiography (CTA) improves diagnostic certainty in the assessment of patients with stable chest pain, its effect on 5-year clinical outcomes is unknown.
In an open-label, multicenter, parallel-group trial, we randomly assigned 4146 patients with stable chest pain who had been referred to a cardiology clinic for evaluation to standard care plus CTA (2073 patients) or to standard care alone (2073 patients). Investigations, treatments, and clinical outcomes were assessed over 3 to 7 years of follow-up. The primary end point was death from coronary heart disease or nonfatal myocardial infarction at 5 years.
The median duration of follow-up was 4.8 years, which yielded 20,254 patient-years of follow-up. The 5-year rate of the primary end point was lower in the CTA group than in the standard-care group (2.3% [48 patients] vs. 3.9% [81 patients]; hazard ratio, 0.59; 95% confidence interval [CI], 0.41 to 0.84; P=0.004). Although the rates of invasive coronary angiography and coronary revascularization were higher in the CTA group than in the standard-care group in the first few months of follow-up, overall rates were similar at 5 years: invasive coronary angiography was performed in 491 patients in the CTA group and in 502 patients in the standard-care group (hazard ratio, 1.00; 95% CI, 0.88 to 1.13), and coronary revascularization was performed in 279 patients in the CTA group and in 267 in the standard-care group (hazard ratio, 1.07; 95% CI, 0.91 to 1.27). However, more preventive therapies were initiated in patients in the CTA group (odds ratio, 1.40; 95% CI, 1.19 to 1.65), as were more antianginal therapies (odds ratio, 1.27; 95% CI, 1.05 to 1.54). There were no significant between-group differences in the rates of cardiovascular or noncardiovascular deaths or deaths from any cause.
In this trial, the use of CTA in addition to standard care in patients with stable chest pain resulted in a significantly lower rate of death from coronary heart disease or nonfatal myocardial infarction at 5 years than standard care alone, without resulting in a significantly higher rate of coronary angiography or coronary revascularization. (Funded by the Scottish Government Chief Scientist Office and others; SCOT-HEART ClinicalTrials.gov number, NCT01149590 .).
尽管冠状动脉 CT 血管造影(CTA)提高了稳定型胸痛患者评估的诊断确定性,但它对 5 年临床结局的影响尚不清楚。
在一项开放标签、多中心、平行组试验中,我们随机分配了 4146 名因稳定型胸痛而被转诊至心脏病诊所进行评估的患者,将他们分为标准治疗加 CTA 组(2073 例)或单独标准治疗组(2073 例)。在 3 至 7 年的随访期间评估了检查、治疗和临床结局。主要终点是 5 年时的冠心病死亡或非致死性心肌梗死。
中位随访时间为 4.8 年,随访了 20254 患者年。CTA 组的 5 年主要终点发生率低于标准治疗组(2.3%[48 例]比 3.9%[81 例];风险比,0.59;95%置信区间[CI],0.41 至 0.84;P=0.004)。尽管在随访的最初几个月中 CTA 组的侵入性冠状动脉造影和冠状动脉血运重建率高于标准治疗组,但在 5 年时总体发生率相似:CTA 组进行了 491 例侵入性冠状动脉造影,标准治疗组进行了 502 例(风险比,1.00;95%CI,0.88 至 1.13),CTA 组进行了 279 例冠状动脉血运重建,标准治疗组进行了 267 例(风险比,1.07;95%CI,0.91 至 1.27)。然而,CTA 组开始使用更多的预防性治疗(比值比,1.40;95%CI,1.19 至 1.65)和更多的抗心绞痛治疗(比值比,1.27;95%CI,1.05 至 1.54)。两组之间心血管或非心血管死亡或任何原因导致的死亡发生率无显著差异。
在这项试验中,与单独标准治疗相比,在稳定型胸痛患者中使用 CTA 联合标准治疗可显著降低 5 年时冠心病死亡或非致死性心肌梗死的发生率,而不会导致冠状动脉造影或冠状动脉血运重建的发生率显著升高。(由苏格兰政府首席科学家办公室和其他机构资助;SCOT-HEART ClinicalTrials.gov 编号,NCT01149590)。