Department of Radiology, Charité-Universitätsmedizin Berlin, Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany.
Department of Clinical Epidemiology and Applied Biostatistics, Universitätsklinikum Tübingen, Tübingen, Germany.
JAMA Cardiol. 2024 Apr 1;9(4):346-356. doi: 10.1001/jamacardio.2024.0001.
The effectiveness and safety of computed tomography (CT) and invasive coronary angiography (ICA) in different age groups is unknown.
To determine the association of age with outcomes of CT and ICA in patients with stable chest pain.
DESIGN, SETTING, AND PARTICIPANTS: The assessor-blinded Diagnostic Imaging Strategies for Patients With Stable Chest Pain and Intermediate Risk of Coronary Artery Disease (DISCHARGE) randomized clinical trial was conducted between October 2015 and April 2019 in 26 European centers. Patients referred for ICA with stable chest pain and an intermediate probability of obstructive coronary artery disease were analyzed in an intention-to-treat analysis. Data were analyzed from July 2022 to January 2023.
Patients were randomly assigned to a CT-first strategy or a direct-to-ICA strategy.
MACE (ie, cardiovascular death, nonfatal myocardial infarction, or stroke) and major procedure-related complications. The primary prespecified outcome of this secondary analysis of age was major adverse cardiovascular events (MACE) at a median follow-up of 3.5 years.
Among 3561 patients (mean [SD] age, 60.1 [10.1] years; 2002 female [56.2%]), 2360 (66.3%) were younger than 65 years, 982 (27.6%) were between ages 65 to 75 years, and 219 (6.1%) were older than 75 years. The primary outcome was MACE at a median (IQR) follow-up of 3.5 (2.9-4.2) years for 3523 patients (99%). Modeling age as a continuous variable, age, and randomization group were not associated with MACE (hazard ratio, 1.02; 95% CI, 0.98-1.07; P for interaction = .31). Age and randomization group were associated with major procedure-related complications (odds ratio, 1.15; 95% CI, 1.05-1.27; P for interaction = .005), which were lower in younger patients.
Age did not modify the effect of randomization group on the primary outcome of MACE but did modify the effect on major procedure-related complications. Results suggest that CT was associated with a lower risk of major procedure-related complications in younger patients.
ClinicalTrials.gov Identifier: NCT02400229.
在不同年龄组中，计算机断层扫描（CT）和有创性冠状动脉造影（ICA）的有效性和安全性尚不清楚。
确定年龄与稳定型胸痛患者 CT 和 ICA 结果的相关性。
设计、地点和参与者：在 2015 年 10 月至 2019 年 4 月期间，在欧洲 26 个中心进行了评估者盲法的稳定型胸痛和中等程度冠状动脉疾病风险患者的诊断成像策略（DISCHARGE）随机临床试验。对因稳定型胸痛和中等程度阻塞性冠状动脉疾病而接受 ICA 检查的患者进行意向治疗分析。数据分析于 2022 年 7 月至 2023 年 1 月进行。
患者被随机分配到 CT 优先策略或直接 ICA 策略。
主要不良心血管事件（MACE，即心血管死亡、非致死性心肌梗死或中风）和主要与程序相关的并发症。本二次分析中年龄的主要预设结局是 3.5 年中位数随访时的主要不良心血管事件（MACE）。
在 3561 例患者（平均[标准差]年龄为 60.1[10.1]岁；2002 例女性[56.2%]）中，2360 例（66.3%）年龄小于 65 岁，982 例（27.6%）年龄在 65 至 75 岁之间，219 例（6.1%）年龄大于 75 岁。3523 例患者（99%）中位（IQR）随访 3.5（2.9-4.2）年时主要结局为 MACE。将年龄视为连续变量时，年龄和随机分组与 MACE 无关（风险比，1.02；95%CI，0.98-1.07；P 交互 = .31）。年龄和随机分组与主要与程序相关的并发症相关（优势比，1.15；95%CI，1.05-1.27；P 交互 = .005），年轻患者的风险较低。
年龄并未改变随机分组对 MACE 主要结局的影响，但确实改变了对主要与程序相关的并发症的影响。结果表明，在年轻患者中，CT 与较低的主要与程序相关并发症风险相关。
ClinicalTrials.gov 标识符：NCT02400229。
