Prognostic Value of Plaque Volume in Patients With First Diagnosis of Coronary Artery Disease: A Substudy of the PROMISE Randomized Clinical Trial.

Background

To assess the incremental prognostic value of quantitative CAD measures in symptomatic outpatients without known CAD.

评估定量冠状动脉疾病（CAD）测量在没有已知CAD的有症状门诊患者中增加的预后价值。

DESIGN, SETTING, AND PARTICIPANTS: This post hoc analysis involved a prospective randomized clinical trial conducted across 193 clinical sites in North America.

设计、环境和参与者：这项事后分析涉及一项在北美193个临床站点进行的前瞻性随机临床试验。

Participants were symptomatic outpatients without known CAD who were randomized to receive CCTA.

参与者是有症状的门诊患者，没有已知的冠状动脉疾病（CAD），被随机分配接受冠状动脉计算机断层扫描血管造影（CCTA）。

The trial was conducted from July 27, 2010, to October 31, 2014, and the data analyzed for this report from January 2021 to July 2024.

该试验从2010年7月27日开始，至2014年10月31日结束，本报告所分析的数据是从2021年1月至2024年7月期间进行的。

exposures

Core laboratory-based quantitative plaque measures, including total plaque volume (TPV), calcified (CPV) and noncalcified (NCPV) plaque volume, low-attenuation plaque volume (LAPV), total plaque burden (TPB), and noncalcified plaque burden (NCPB), normalized with vessel volume.

基于核心实验室的定量斑块测量，包括总斑块体积（TPV）、钙化斑块体积（CPV）和非钙化斑块体积（NCPV）、低密度斑块体积（LAPV）、总斑块负担（TPB）和非钙化斑块负担（NCPB），均以血管体积进行标准化处理。

main_outcomes_and_measures

The primary outcome was major adverse cardiovascular events MACE (composite of death, nonfatal myocardial infarction, or hospitalization for unstable angina).

主要结果是主要不良心血管事件MACE（包括死亡、非致命性心肌梗死或不稳定型心绞痛住院的复合终点）

Optimal predictive cut points for plaque measures were identified using Euclidean distance methods and tested in multivariable Cox regression models.

使用欧几里得距离方法确定了斑块测量的最佳预测切点，并在多变量Cox回归模型中进行了测试。

Results

Among 4267 patients, the mean (SD) age was 60.4 (8.2) years; 2199 patients (51.5%) were female and 2068 (48.5%) were male.

在4267名患者中，平均（标准差）年龄为60.4（8.2）岁；2199名患者（51.5%）为女性，2068名患者（48.5%）为男性。

The median (IQR) TPV was 39.8 mm3 (0-167) mm3.

TPV的中位数（四分位数间距）为39.8 mm3（0-167）mm3。

Patients with TPV at the median or higher were older (mean [SD] age, 62.1 [8.4] vs 58.7 [7.5] years for those with lower than median TPV), more likely to be male (1286/2133 [60.3%] vs 782/2134 [36.6%], respectively), and had higher median (IQR) atherosclerotic cardiovascular disease risk scores (14.4 [8.8-24.0] vs 7.9 [4.5-13.4], respectively).

具有中位数或更高TPV的患者年龄较大（平均[标准差]年龄为62.1[8.4]岁，而低于中位数TPV的患者为58.7[7.5]岁），更可能是男性（1286/2133[60.3%]对比782/2134[36.6%]），并且具有更高的中位数（四分位数间距）动脉粥样硬化心血管疾病风险评分（14.4[8.8-24.0]对比7.9[4.5-13.4]）。

TPB showed similar demographic associations.

TPB显示出类似的性别关联。

Both TPB and NCPB independently predicted MACE after adjusting for clinical risk factors, statin use, and qualitative CCTA findings (TPB: adjusted HR [aHR], 1.18; 95% CI, 1.05-1.34; P = .006; NCPB: aHR, 1.20; 95% CI, 1.05-1.37; P = .007).

在调整了临床风险因素、他汀类药物使用和定性CCTA结果后，TPB和NCPB均独立预测了主要不良心血管事件（MACE）（TPB：调整后风险比[aHR]，1.18；95%置信区间[CI]，1.05-1.34；P = .006；NCPB：aHR，1.20；95% CI，1.05-1.37；P = .007）。

Optimal cutoffs of TPV 87 mm3 or greater, TPB 35% or greater, and NCPB 20% or greater were each associated with nearly a 2-fold increase in MACE risk (TPV: aHR, 2.07; 95% CI, 1.24-3.49; TPB: aHR, 1.96; 95% CI, 1.21-3.17; and NCPB: aHR, 1.77; 95% CI, 1.12-2.82).

TPV 87毫米立方或更大、TPB 35%或更大以及NCPB 20%或更大的最佳临界值均与主要不良心血管事件（MACE）风险几乎增加2倍相关（TPV：aHR，2.07；95%置信区间[CI]，1.24-3.49；TPB：aHR，1.96；95% CI，1.21-3.17；和NCPB：aHR，1.77；95% CI，1.12-2.82）。

conclusions_and_relevance

In symptomatic patients without known CAD, coronary plaque volumes and burdens are low but are related to CAD risk factors and independently predictive of MACE.

在有症状但未明确诊断为冠状动脉疾病（CAD）的患者中，冠状动脉斑块体积和负担较低，但与CAD风险因素相关，并且独立预测主要不良心血管事件（MACE）的能力。

The clinical utility of quantitative CCTA-based cardiovascular risk estimation in early CAD requires prospective evaluation.

需要前瞻性评估定量冠状动脉计算机断层扫描（CCTA）在早期CAD中基于心血管风险评估的临床效用。

trial_registration

ClinicalTrials.gov Identifier: NCT01174550.

临床试验注册号：NCT01174550。