Health Status Outcomes After Computed Tomography or Invasive Coronary Angiography for Stable Chest Pain: A Prespecified Secondary Analysis of the DISCHARGE Randomized Clinical Trial.

Background

To evaluate CT and ICA first-test strategies on quality of life (QOL) and angina.

评估CT和ICA首次检测策略对生活质量（QOL）和心绞痛的影响。

DESIGN, SETTING, AND PARTICIPANTS: The Diagnostic Imaging Strategies for Patients With Stable Chest Pain and Intermediate Risk of Coronary Artery Disease (DISCHARGE) randomized clinical trial, conducted between October 2015 and April 2019 in 26 European centers, followed up patients with stable chest pain and intermediate probability of coronary artery disease for a median 3.5 years.

设计、环境和参与者：在2015年10月至2019年4月期间，于26个欧洲中心进行的针对稳定胸痛和冠状动脉疾病中等风险患者的诊断影像策略（DISCHARGE）随机临床试验，对稳定胸痛和冠状动脉疾病中等可能性的患者进行了中位3.5年的随访。

Data analysis was from December 2023 to July 2024.

数据分析是从2023年12月至2024年7月进行的。

Methods

Random assignment to CT or ICA.

随机分配至CT或ICA治疗组。

main_outcomes_and_measures

Patient-reported Euro QOL 5-dimensions descriptive system (EQ-5D-3L) visual analog scale (EQ-5D-3L-VAS) and 12-item Short Form Health Survey (SF-12) physical component score (SF-12-PCS) were primary prespecified QOL outcomes.

患者报告的欧洲生活质量5维描述系统（EQ-5D-3L）视觉模拟量表（EQ-5D-3L-VAS）和12项简短形式健康调查（SF-12）身体成分评分（SF-12-PCS）是主要预设的生活质量结果指标。

Angina was the primary prespecified chest pain outcome.

心绞痛是主要预设的胸部疼痛结果。

The EQ-5D-3L-VAS, summary index (EQ-5D-3L-SI), mental component summary (SF-12-MCS), and Hospital Anxiety and Depression Scale-anxiety subscale (HADS-A) and Hospital Anxiety and Depression Scale-anxiety subscale (HADS-D) were also evaluated.

还评估了EQ-5D-3L-VAS、总结指数（EQ-5D-3L-SI）、精神成分总结（SF-12-MCS）以及医院焦虑和抑郁量表-焦虑分量（HADS-A）和医院焦虑和抑郁量表-抑郁分量（HADS-D）。

Results

Among 3561 patients (mean [SD] age, 60.1 [10.1] years; 2002 female [56.2%]), 1735 (96.0%) in the CT group and 1671 (95.3%) in the ICA group completed at least 1 health status assessment during 3.5 years of follow-up.

在3561名患者中（平均年龄[标准差]为60.1[10.1]岁；女性2002名[56.2%]），随访3.5年期间，CT组有1735名（96.0%）和ICA组有1671名（95.3%）患者至少完成了一次健康状况评估。

Health status outcomes were similar between groups, with significant improvements in all QOL outcomes (eg, mean EQ-5D-3L-VAS 3.5 year minus baseline score: CT = 4.0; 95% CI, 3.1-4.9; P < .001; ICA = 4.6; 95% CI, 3.6-5.6; P =.002), except HADS-D, which improved only in the CT group (mean EQ-5D-3L-VAS 3.5 year minus baseline score: CT = -0.2; 95% CI, -0.4 to 0; P = .04; ICA = -0.2; 95% CI, -0.4 to 0; P = .12).

两组的健康状况结果相似，所有生活质量指标均有显著改善（例如，平均EQ-5D-3L-VAS 3.5年与基线差值：CT组为4.0；95%置信区间[CI]，3.1-4.9；P < .001；ICA组为4.6；95% CI，3.6-5.6；P =.002），除了HADS-D仅在CT组有所改善（平均EQ-5D-3L-VAS 3.5年与基线差值：CT组为-0.2；95% CI，-0.4至0；P = .04；ICA组为-0.2；95% CI，-0.4至0；P = .12）。

Female patients had worse baseline and follow-up QOL than male patients (eg, baseline EQ-5D-3L-VAS difference between men and women = 5.2; 95% CI, 4.0-6.3; P <.001 and at 3.5 years = 3.1; 95% CI, 1.9-4.4; P < .001) but showed greater improvements in EQ-5D-3L-VAS (-1.9; 95% CI, -3.4 to -0.5; P = .009), SF-12-PCS (-1.4; -2.1 to -0.7; P < .001), and HADS-A (0.3; 0-0.7; P = .04).

女性患者的基线和随访QOL（生活质量）比男性患者差（例如，男性和女性之间的基线EQ-5D-3L-VAS差异为5.2；95%置信区间，4.0-6.3；P <.001，而在3.5年时为3.1；95%置信区间，1.9-4.4；P < .001），但在EQ-5D-3L-VAS（-1.9；95%置信区间，-3.4至-0.5；P = .009）、SF-12-PCS（-1.4；-2.1至-0.7；P < .001）和HADS-A（0.3；0-0.7；P = .04）方面显示出更大的改善。

Angina outcomes were comparable between groups at 3.5 years, with similar 1-year rates in the CT group but higher rates in female than male patients in the ICA group (10.2% vs 6.2%; P = .007).

在3.5年的随访中，两组的胸痛结果相当，CT组的1年率相似，但在ICA组中，女性患者的比率高于男性患者（10.2% vs 6.2%；P = .007）。

conclusions_and_relevance

Results of this secondary analysis of the DISCHARGE randomized clinical trial reveal that there was no significant difference in QOL or chest pain outcomes with CT vs ICA at 3.5 years.

这项对DISCHARGE随机临床试验的次要分析结果显示，在3.5年的随访中，CT与ICA在生活质量或胸痛结果上没有显著差异。

Female patients had worse health status than male patients at baseline and follow-up, and CT or ICA did not affect these differences.

在基线和随访时，女性患者的健康状况比男性患者差，CT或ICA并未影响这些差异。

trial_registration

ClinicalTrials.gov Identifier: NCT02400229.

临床试验注册号：NCT02400229。