Rieckmann Nina, Neumann Konrad, Maurovich-Horvat Pál, Kofoed Klaus F, Benedek Theodora, Bosserdt Maria, Donnelly Patrick, Rodriguez-Palomares José, Erglis Andrejs, Štechovský Cyril, Šakalyte Gintare, Adic Nada Cemerlic, Gutberlet Matthias, Diez Ignacio, Davis Gershan, Zimmermann Elke, Kepka Cezary, Vidakovic Radosav, Francone Marco, Ilnicka-Suckiel Malgorzata, Plank Fabian, Knuuti Juhani, Faria Rita, Schröder Stephen, Berry Colin, Saba Luca, Ruzsics Balazs, Kubiak Christine, Hansen Kristian Schultz, Müller-Nordhorn Jacqueline, Merkely Bela, Knudsen Andreas D, Benedek Imre, Orr Clare, Valente Filipa Xavier, Zvaigzne Ligita, Suchánek Vojtech, Zajanckauskiene Laura, Adic Filip, Woinke Michael, Waters Darragh, Lecumberri Iñigo, Thwaite Erica, Laule Michael, Kruk Mariusz, Neskovic Aleksandar N, Birtolo Lucia Ilaria, Kusmierz Donata, Feuchtner Gudrun, Pietilä Mikko, Ribeiro Vasco Gama, Drosch Tanja, Delles Christian, Matta Gildo, Fisher Michael, Szilveszter Bálint, Larsen Linnea, Ratiu Mihaela, Kelly Stephanie, Garcia Del Blanco Bruno, Drobni Zsófia D, Jurlander Birgit, Regan Susan, Calabria Hug Cuéllar, Boussoussou Melinda, Engstrøm Thomas, Hodas Roxana, Napp Adriane E, Haase Robert, Feger Sarah, Mohamed Mahmoud M A, Dreger Henryk, Rief Matthias, Wieske Viktoria, Estrella Melanie, Michallek Florian, Mark Daniel B, Martus Peter, Dodd Jonathan D, Sox Harold C, Serna-Higuita Lina M, Dewey Marc
Institute of Public Health, Charité-Universitätsmedizin Berlin, Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany.
Department of Radiology, Medical Imaging Center, Semmelweis University, Budapest, Hungary.
JAMA Cardiol. 2025 May 14. doi: 10.1001/jamacardio.2025.0992.
The effect of computed tomography (CT) vs invasive coronary angiography (ICA) on health status outcomes is unknown.
To evaluate CT and ICA first-test strategies on quality of life (QOL) and angina.
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. Data analysis was from December 2023 to July 2024.
Random assignment to CT or ICA.
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. Angina was the primary prespecified chest pain outcome. 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.
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. 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). 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). 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).
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. Female patients had worse health status than male patients at baseline and follow-up, and CT or ICA did not affect these differences.
ClinicalTrials.gov Identifier: NCT02400229.
计算机断层扫描（CT）与有创冠状动脉造影（ICA）对健康状况结果的影响尚不清楚。
评估CT和ICA首次检测策略对生活质量（QOL）和心绞痛的影响。
设计、设置和参与者：稳定型胸痛和冠状动脉疾病中度风险患者的诊断成像策略（DISCHARGE）随机临床试验，于2015年10月至2019年4月在26个欧洲中心进行，对稳定型胸痛和冠状动脉疾病中度可能性的患者进行了为期3.5年的中位数随访。数据分析时间为2023年12月至2024年7月。
随机分配至CT或ICA组。
患者报告的欧洲五维健康量表描述系统（EQ-5D-3L）视觉模拟量表（EQ-5D-3L-VAS）和12项简短健康调查问卷（SF-12）身体成分得分（SF-12-PCS）是预先指定的主要QOL结局。心绞痛是预先指定的主要胸痛结局。还评估了EQ-5D-3L-VAS、汇总指数（EQ-5D-3L-SI）、心理成分汇总（SF-12-MCS）以及医院焦虑抑郁量表焦虑分量表（HADS-A）和医院焦虑抑郁量表抑郁分量表（HADS-D）。
在3561例患者（平均[标准差]年龄，60.1[10.1]岁；2002例女性[56.2%]）中，CT组1735例（96.0%）和ICA组1671例（95.3%）在3.5年随访期间至少完成了1次健康状况评估。两组之间的健康状况结果相似，所有QOL结局均有显著改善（例如，平均EQ-5D-3L-VAS 3.5年减去基线得分：CT组=4.0；95%置信区间，3.1 - 4.9；P <.001；ICA组=4.6；95%置信区间，3.6 - 5.6；P =.002），除HADS-D外，HADS-D仅在CT组有所改善（平均EQ-5D-3L-VAS 3.5年减去基线得分：CT组=-0.2；95%置信区间，-0.4至0；P = 0.04；ICA组=-0.2；95%置信区间，-0.4至0；P = 0.12）。女性患者的基线和随访QOL比男性患者差（例如，男性和女性之间的基线EQ-5D-3L-VAS差异=5.2；95%置信区间，4.0 - 6.3；P <.001，3.5年时=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 = 0.009）、SF-12-PCS（-1.4；-2.1至-0.7；P <.001）和HADS-A（0.3；0至0.7；P = 0.04）方面改善更大。3.5年时两组之间的心绞痛结局相当，CT组1年发生率相似，但ICA组女性患者发生率高于男性患者（10.2%对6.2%；P = 0.007）。
DISCHARGE随机临床试验的这项二次分析结果显示，3.5年时CT与ICA在QOL或胸痛结局方面无显著差异。女性患者在基线和随访时的健康状况比男性患者差，且CT或ICA并未影响这些差异。
ClinicalTrials.gov标识符：NCT02400229。
