Lancet：冠状动脉CT血管造影引导下稳定胸痛患者的治疗：苏格兰苏格兰心脏随机对照试验的10年结果

Abstract

Background: The Scottish Computed Tomography of the Heart (SCOT-HEART) trial demonstrated that management guided by coronary CT angiography (CCTA) improved the diagnosis, management, and outcome of patients with stable chest pain. We aimed to assess whether CCTA-guided care results in sustained long-term improvements in management and outcomes.

背景：苏格兰心脏计算机断层扫描（SCOT-HEART）试验表明，冠状动脉CT血管造影（CCTA）指导的诊疗可改善稳定型胸痛患者的诊断、治疗及预后。本研究旨在评估CCTA指导的诊疗是否能持续改善长期管理及临床结局。

Methods: SCOT-HEART was an open-label, multicentre, parallel group trial for which patients were recruited from 12 outpatient cardiology chest pain clinics across Scotland. Eligible patients were aged 18-75 years with symptoms of suspected stable angina due to coronary heart disease. Patients were randomly assigned (1:1) to standard of care plus CCTA or standard of care alone. In this prespecified 10-year analysis, prescribing data, coronary procedural interventions, and clinical outcomes were obtained through record linkage from national registries. The primary outcome was coronary heart disease death or non-fatal myocardial infarction on an intention-to-treat basis. This trial is registered at ClinicalTrials.gov (NCT01149590) and is complete.

方法：SCOT-HEART是一项开放标签、多中心、平行分组试验，受试者来自苏格兰12家心脏科门诊的胸痛患者。纳入标准为18-75岁、因冠心病疑似稳定型心绞痛症状的患者。患者按1:1随机分配至标准治疗联合CCTA组或单纯标准治疗组。在此预设的10年分析中，通过国家注册数据库获取处方数据、冠状动脉介入治疗及临床结局。主要终点为意向治疗分析下的冠心病死亡或非致死性心肌梗死。本试验注册于ClinicalTrials.gov（NCT01149590），目前已结束。

Findings: Between Nov 18, 2010, and Sept 24, 2014, 4146 patients were recruited (mean age 57 years [SD 10], 2325 [56·1%] male, 1821 [43·9%] female), with 2073 randomly assigned to standard care and CCTA and 2073 to standard care alone. After a median of 10·0 years (IQR 9·3-11·0), coronary heart disease death or non-fatal myocardial infarction was less frequent in the CCTA group compared with the standard care group (137 [6·6%] vs 171 [8·2%]; hazard ratio [HR] 0·79 [95% CI 0·63-0·99], p=0·044). Rates of all-cause, cardiovascular, and coronary heart disease death, and non-fatal stroke, were similar between the groups (p>0·05 for all), but non-fatal myocardial infarctions (90 [4·3%] vs 124 [6·0%]; HR 0·72 [0·55-0·94], p=0·017) and major adverse cardiovascular events (172 [8·3%] vs 214 [10·3%]; HR 0·80 [0·65-0·97], p=0·026) were less frequent in the CCTA group. Rates of coronary revascularisation procedures were similar (315 [15·2%] vs 318 [15·3%]; HR 1·00 [0·86-1·17], p=0·99) but preventive therapy prescribing remained more frequent in the CCTA group (831 [55·9%] of 1486 vs 728 [49·0%] of 1485 patients with available data; odds ratio 1·17 [95% CI 1·01-1·36], p=0·034).

结果：2010年11月18日至2014年9月24日期间，共纳入4146例患者（平均年龄57岁[SD 10]，男性2325例[56.1%]，女性1821例[43.9%]），其中2073例被随机分配至标准治疗联合CCTA组，2073例分配至单纯标准治疗组。中位随访10.0年（IQR 9.3-11.0）后，与标准治疗组相比，CCTA组的冠心病死亡或非致死性心肌梗死发生率更低（137例[6.6%] vs 171例[8.2%]；风险比[HR] 0.79[95% CI 0.63–0.99]，p=0.044）。两组全因死亡、心血管死亡、冠心病死亡及非致死性卒中发生率相似（均p>0.05），但CCTA组的非致死性心肌梗死（90例[4.3%] vs 124例[6.0%]；HR 0.72[0.55–0.94]，p=0.017）和主要不良心血管事件（172例[8.3%] vs 214例[10.3%]；HR 0.80[0.65–0.97]，p=0.026）发生率更低。两组冠状动脉血运重建术比例相近（315例[15.2%] vs 318例[15.3%]；HR 1.00[0.86–1.17]，p=0.99），但CCTA组的预防性药物处方率仍更高（1486例中有831例[55.9%] vs 1485例中有728例[49.0%]；比值比1.17[95% CI 1.01–1.36]，p=0.034）。

Interpretation: After 10 years, CCTA-guided management of patients with stable chest pain was associated with a sustained reduction in coronary heart disease death or non-fatal myocardial infarction. Identification of coronary atherosclerosis by CCTA improves long-term cardiovascular disease prevention in patients with stable chest pain.

结论：经过10年随访，CCTA指导的稳定型胸痛患者管理与冠心病死亡或非致死性心肌梗死的持续减少相关。通过CCTA识别冠状动脉粥样硬化可改善稳定型胸痛患者的长期心血管疾病预防。