稳定胸痛的计算机断层扫描或侵入性冠状动脉造影后的健康状况:出院随机临床试验的预先指定的二次分析。

IF 14.8 1区 医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS
Nina Rieckmann, Konrad Neumann, Pál Maurovich-Horvat, Klaus F Kofoed, Theodora Benedek, Maria Bosserdt, Patrick Donnelly, José Rodriguez-Palomares, Andrejs Erglis, Cyril Štechovský, Gintare Šakalyte, Nada Cemerlic Adic, Matthias Gutberlet, Ignacio Diez, Gershan Davis, Elke Zimmermann, Cezary Kepka, Radosav Vidakovic, Marco Francone, Malgorzata Ilnicka-Suckiel, Fabian Plank, Juhani Knuuti, Rita Faria, Stephen Schröder, Colin Berry, Luca Saba, Balazs Ruzsics, Christine Kubiak, Kristian Schultz Hansen, Jacqueline Müller-Nordhorn, Bela Merkely, Andreas D Knudsen, Imre Benedek, Clare Orr, Filipa Xavier Valente, Ligita Zvaigzne, Vojtech Suchánek, Laura Zajanckauskiene, Filip Adic, Michael Woinke, Darragh Waters, Iñigo Lecumberri, Erica Thwaite, Michael Laule, Mariusz Kruk, Aleksandar N Neskovic, Lucia Ilaria Birtolo, Donata Kusmierz, Gudrun Feuchtner, Mikko Pietilä, Vasco Gama Ribeiro, Tanja Drosch, Christian Delles, Gildo Matta, Michael Fisher, Bálint Szilveszter, Linnea Larsen, Mihaela Ratiu, Stephanie Kelly, Bruno Garcia Del Blanco, Zsófia D Drobni, Birgit Jurlander, Susan Regan, Hug Cuéllar Calabria, Melinda Boussoussou, Thomas Engstrøm, Roxana Hodas, Adriane E Napp, Robert Haase, Sarah Feger, Mahmoud M A Mohamed, Henryk Dreger, Matthias Rief, Viktoria Wieske, Melanie Estrella, Florian Michallek, Daniel B Mark, Peter Martus, Jonathan D Dodd, Harold C Sox, Lina M Serna-Higuita, Marc Dewey
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引用次数: 0

摘要

重要性:计算机断层扫描(CT)与侵入性冠状动脉造影(ICA)对健康状况的影响尚不清楚。目的:评价CT和ICA初测策略对生活质量和心绞痛的影响。设计、环境和参与者:2015年10月至2019年4月在26个欧洲中心进行的稳定性胸痛和中等冠状动脉疾病风险患者的诊断成像策略(DISCHARGE)随机临床试验,对稳定性胸痛和中等冠状动脉疾病风险的患者进行了中位3.5年的随访。数据分析时间为2023年12月至2024年7月。干预措施:随机分配到CT或ICA组。主要结果和测量方法: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项简短健康调查(SF-12)身体成分评分(SF-12- pcs)是预先规定的主要生活质量结果。心绞痛是主要的预先规定的胸痛结局。并对EQ-5D-3L-VAS、总结指数(EQ-5D-3L-SI)、心理成分总结(SF-12-MCS)、医院焦虑抑郁量表-焦虑子量表(HADS-A)和医院焦虑抑郁量表-焦虑子量表(HADS-D)进行评估。结果:3561例患者(平均[SD]年龄60.1[10.1]岁;随访3.5年,CT组1735例(96.0%),ICA组1671例(95.3%)完成了至少1次健康状况评估。两组之间的健康状况结果相似,所有生活质量结果均有显著改善(例如,EQ-5D-3L-VAS平均3.5年减去基线评分:CT = 4.0;95% ci, 3.1-4.9;P < .001;Ica = 4.6;95% ci, 3.6-5.6;P =.002),但HADS-D仅在CT组有所改善(EQ-5D-3L-VAS平均3.5年减去基线评分:CT = -0.2;95% CI, -0.4 ~ 0;p = .04;Ica = -0.2;95% CI, -0.4 ~ 0;P = .12)。女性患者的基线和随访生活质量均差于男性患者(例如,男女基线EQ-5D-3L-VAS差异= 5.2;95% ci, 4.0-6.3;结论和相关性:这项对DISCHARGE随机临床试验的二次分析结果显示,在3.5年时,CT组与ICA组在生活质量或胸痛结局方面没有显著差异。女性患者在基线和随访时的健康状况差于男性患者,CT或ICA对这些差异没有影响。试验注册:ClinicalTrials.gov标识符:NCT02400229。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Health Status Outcomes After Computed Tomography or Invasive Coronary Angiography for Stable Chest Pain: A Prespecified Secondary Analysis of the DISCHARGE Randomized Clinical Trial.

Importance: The effect of computed tomography (CT) vs invasive coronary angiography (ICA) on health status outcomes is unknown.

Objective: 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.

Interventions: Random assignment to CT or ICA.

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. 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.

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. 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).

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

Trial registration: ClinicalTrials.gov Identifier: NCT02400229.

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来源期刊
JAMA cardiology
JAMA cardiology Medicine-Cardiology and Cardiovascular Medicine
CiteScore
45.80
自引率
1.70%
发文量
264
期刊介绍: JAMA Cardiology, an international peer-reviewed journal, serves as the premier publication for clinical investigators, clinicians, and trainees in cardiovascular medicine worldwide. As a member of the JAMA Network, it aligns with a consortium of peer-reviewed general medical and specialty publications. Published online weekly, every Wednesday, and in 12 print/online issues annually, JAMA Cardiology attracts over 4.3 million annual article views and downloads. Research articles become freely accessible online 12 months post-publication without any author fees. Moreover, the online version is readily accessible to institutions in developing countries through the World Health Organization's HINARI program. Positioned at the intersection of clinical investigation, actionable clinical science, and clinical practice, JAMA Cardiology prioritizes traditional and evolving cardiovascular medicine, alongside evidence-based health policy. It places particular emphasis on health equity, especially when grounded in original science, as a top editorial priority.
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