American heart journal · 2025
Coronary computed tomography angiography versus invasive coronary angiography for interventional triage in acute coronary syndrome: Design of the randomized TRACTION trial.
СтатьяПротокол клинического исследованияНазвание и аннотация: Перевод в очереди
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Sørgaard Mathias Holm, Kristensen Andreas Torp, Eskesen Kristian, Kofoed Klaus Fuglsang, Linde Jesper James, Kelbæk Henning, Ottesen Michael, Neland Keld, Kragelund Charlotte, Bertelsen Mette Lykke Norgaard, Hove Jens Dahlgaard, Mørk Gorm, Kristiansen Ole Peter, Engstrøm Thomas, Lønborg Jacob Thomsen, Kühl Jørgen Tobias, Risom Signe Stelling, Blanche Paul, Olsen Niels Thue
Аннотация
PURPOSE: In patients admitted with acute coronary syndrome, invasive coronary angiography (ICA) is performed to determine which patients need revascularization. Coronary computed tomography angiography (CCTA) offers a widely available, non-invasive alternative that could reduce patient discomfort, procedural risks, and healthcare costs. The current trial aims to determine whether CCTA is noninferior to ICA in determining the interventional strategy for patients admitted with non-ST elevation acute coronary syndrome (NSTE-ACS)(Central Illustration).
METHODS: TRACTION (Team-based Interventional Triage in Acute Coronary Syndrome Based on Noninvasive Coronary Computed Tomography Angiography Versus Invasive Coronary Angiography) is a multicenter, randomized, open-label, noninferiority trial enrolling 2,300 patients. Patients hospitalized with non-ST elevation myocardial infarction or unstable angina with ischemic changes on ECG will be randomized 1:1 to CCTA vs ICA (standard of care). In the CCTA group, a Coronary Team reviews the CCTA and clinical information to determine the interventional strategy. The primary composite endpoint is major adverse cardiac events at 1 year, comprised of all-cause mortality, nonfatal myocardial infarction, hospitalization due to refractory angina, or hospitalization due to heart failure. Secondary outcomes include cardiovascular death, revascularization, symptom status, procedure-related adverse events, and resource utilization. The trial is designed to demonstrate noninferiority if the 95% confidence interval excludes an absolute risk difference of the primary endpoint larger than 5%.
PERSPECTIVES: If CCTA is shown to be noninferior to ICA in patients admitted with NSTE-ACS, CCTA could become the preferred management in a large group of patients. This could result in fewer patients exposed to invasive procedures and improved resource utilization.
CLINICALTRIALS: gov identifier: NCT06101862.
METHODS: TRACTION (Team-based Interventional Triage in Acute Coronary Syndrome Based on Noninvasive Coronary Computed Tomography Angiography Versus Invasive Coronary Angiography) is a multicenter, randomized, open-label, noninferiority trial enrolling 2,300 patients. Patients hospitalized with non-ST elevation myocardial infarction or unstable angina with ischemic changes on ECG will be randomized 1:1 to CCTA vs ICA (standard of care). In the CCTA group, a Coronary Team reviews the CCTA and clinical information to determine the interventional strategy. The primary composite endpoint is major adverse cardiac events at 1 year, comprised of all-cause mortality, nonfatal myocardial infarction, hospitalization due to refractory angina, or hospitalization due to heart failure. Secondary outcomes include cardiovascular death, revascularization, symptom status, procedure-related adverse events, and resource utilization. The trial is designed to demonstrate noninferiority if the 95% confidence interval excludes an absolute risk difference of the primary endpoint larger than 5%.
PERSPECTIVES: If CCTA is shown to be noninferior to ICA in patients admitted with NSTE-ACS, CCTA could become the preferred management in a large group of patients. This could result in fewer patients exposed to invasive procedures and improved resource utilization.
CLINICALTRIALS: gov identifier: NCT06101862.