TY - JOUR

T1 - Comparative effectiveness of initial computed tomography and invasive coronary angiography in women and men with stable chest pain and suspected coronary artery disease

T2 - Multicentre randomised trial

AU - Kofoed, Klaus F.

AU - Bosserdt, Maria

AU - Maurovich-Horvat, Pál

AU - Rieckmann, Nina

AU - Benedek, Theodora

AU - Donnelly, Patrick

AU - Rodriguez-Palomares, José

AU - Erglis, Andrejs

AU - Štěchovský, Cyril

AU - Šakalyte, Gintare

AU - Adić, Filip

AU - Gutberlet, Matthias

AU - Dodd, Jonathan D.

AU - Diez, Ignacio

AU - Davis, Gershan

AU - Zimmermann, Elke

AU - Kȩpka, Cezary

AU - Vidakovic, Radosav

AU - Francone, Marco

AU - Ilnicka-Suckiel, Małgorzata

AU - Plank, Fabian

AU - Knuuti, Juhani

AU - Faria, Rita

AU - Schröder, Stephen

AU - Berry, Colin

AU - Saba, Luca

AU - Ruzsics, Balazs

AU - Kubiak, Christine

AU - Hansen, Kristian Schultz

AU - Müller-Nordhorn, Jacqueline

AU - Merkely, Bela

AU - Jørgensen, Tem S.

AU - Benedek, Imre

AU - Orr, Clare

AU - Valente, Filipa Xavier

AU - Zvaigzne, Ligita

AU - Suchánek, Vojtěch

AU - Zajančkauskiene, Laura

AU - Čanković, Milenko

AU - Woinke, Michael

AU - Keane, Stephen

AU - Lecumberri, Iñigo

AU - Thwaite, Erica

AU - Laule, Michael

AU - Kruk, Mariusz

AU - Neskovic, Aleksandar N.

AU - Mancone, Massimo

AU - Kuśmierz, Donata

AU - Feuchtner, Gudrun

AU - Engstrøm, Thomas

AU - The DISCHARGE Trial Group

N1 - Publisher Copyright: © Author(s) (or their employer(s)) 2019.

PY - 2022

Y1 - 2022

N2 - Objective: To assess the comparative effectiveness of computed tomography and invasive coronary angiography in women and men with stable chest pain suspected to be caused by coronary artery disease. Design: Prospective, multicentre, randomised pragmatic trial. Setting: Hospitals at 26 sites in 16 European countries. Participants: 2002 (56.2%) women and 1559 (43.8%) men (total of 3561 patients) with suspected coronary artery disease referred for invasive coronary angiography on the basis of stable chest pain and a pre-test probability of obstructive coronary artery disease of 10-60%. Intervention: Both women and men were randomised 1:1 (with stratification by gender and centre) to a strategy of either computed tomography or invasive coronary angiography as the initial diagnostic test (1019 and 983 women, and 789 and 770 men, respectively), and an intention-to-treat analysis was performed. Randomised allocation could not be blinded, but outcomes were assessed by investigators blinded to randomisation group. Main outcome measures: The primary endpoint was major adverse cardiovascular events (MACE; cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke). Key secondary endpoints were an expanded MACE composite (cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, transient ischaemic attack, or major procedure related complication) and major procedure related complications. Results: Follow-up at a median of 3.5 years was available in 98.9% (1979/2002) of women and in 99.0% (1544/1559) of men. No statistically significant gender interaction was found for MACE (P=0.29), the expanded MACE composite (P=0.45), or major procedure related complications (P=0.11). In both genders, the rate of MACE did not differ between the computed tomography and invasive coronary angiography groups. In men, the expanded MACE composite endpoint occurred less frequently in the computed tomography group than in the invasive coronary angiography group (22 (2.8%) v 41 (5.3%); hazard ratio 0.52, 95% confidence interval 0.31 to 0.87). In women, the risk of having a major procedure related complication was lower in the computed tomography group than in the invasive coronary angiography group (3 (0.3%) v 21 (2.1%); hazard ratio 0.14, 0.04 to 0.46). Conclusion: This study found no evidence for a difference between women and men in the benefit of using computed tomography rather than invasive coronary angiography as the initial diagnostic test for the management of stable chest pain in patients with an intermediate pre-test probability of coronary artery disease. An initial computed tomography scan was associated with fewer major procedure related complications in women and a lower frequency of the expanded MACE composite in men. Trial registration: NCT02400229ClinicalTrials.gov NCT02400229.

AB - Objective: To assess the comparative effectiveness of computed tomography and invasive coronary angiography in women and men with stable chest pain suspected to be caused by coronary artery disease. Design: Prospective, multicentre, randomised pragmatic trial. Setting: Hospitals at 26 sites in 16 European countries. Participants: 2002 (56.2%) women and 1559 (43.8%) men (total of 3561 patients) with suspected coronary artery disease referred for invasive coronary angiography on the basis of stable chest pain and a pre-test probability of obstructive coronary artery disease of 10-60%. Intervention: Both women and men were randomised 1:1 (with stratification by gender and centre) to a strategy of either computed tomography or invasive coronary angiography as the initial diagnostic test (1019 and 983 women, and 789 and 770 men, respectively), and an intention-to-treat analysis was performed. Randomised allocation could not be blinded, but outcomes were assessed by investigators blinded to randomisation group. Main outcome measures: The primary endpoint was major adverse cardiovascular events (MACE; cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke). Key secondary endpoints were an expanded MACE composite (cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, transient ischaemic attack, or major procedure related complication) and major procedure related complications. Results: Follow-up at a median of 3.5 years was available in 98.9% (1979/2002) of women and in 99.0% (1544/1559) of men. No statistically significant gender interaction was found for MACE (P=0.29), the expanded MACE composite (P=0.45), or major procedure related complications (P=0.11). In both genders, the rate of MACE did not differ between the computed tomography and invasive coronary angiography groups. In men, the expanded MACE composite endpoint occurred less frequently in the computed tomography group than in the invasive coronary angiography group (22 (2.8%) v 41 (5.3%); hazard ratio 0.52, 95% confidence interval 0.31 to 0.87). In women, the risk of having a major procedure related complication was lower in the computed tomography group than in the invasive coronary angiography group (3 (0.3%) v 21 (2.1%); hazard ratio 0.14, 0.04 to 0.46). Conclusion: This study found no evidence for a difference between women and men in the benefit of using computed tomography rather than invasive coronary angiography as the initial diagnostic test for the management of stable chest pain in patients with an intermediate pre-test probability of coronary artery disease. An initial computed tomography scan was associated with fewer major procedure related complications in women and a lower frequency of the expanded MACE composite in men. Trial registration: NCT02400229ClinicalTrials.gov NCT02400229.

U2 - 10.1136/bmj-2022-071133

DO - 10.1136/bmj-2022-071133

M3 - Journal article

C2 - 36261169

AN - SCOPUS:85142711162

JO - The BMJ

JF - The BMJ

SN - 0959-8146

M1 - e071133

ER -