作者
Sebastian Flynn,L. Moore,Massimo Mancone,Nina Rieckmann,Konrad Neumann,Pál Maurovich‐Horvat,Klaus F. Kofoed,Theodora Benedek,Maria Bosserdt,Patrick Donnelly,José F. Rodríguez‐Palomares,Andrejs Ērglis,Cyril Štěchovský,Gintarė Šakalytė,Nada Čemerlić Ađić,Matthias Gutberlet,Ignacio Diez,Gershan Davis,Elke Zimmermann,Cezary Kępka
摘要
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