Piotr Nikodem Rudziński1, Mariusz Kruk2, Cezary Kępka2, U Joseph Schoepf3, Taylor Duguay4, Zofia Dzielińska2, Jerzy Pręgowski2, Adam Witkowski2, Witold Rużyłło2, Marcin Demkow2. 1. Institute of Cardiology in Warsaw, Poland. Electronic address: piotr.rudzinski@ikard.pl. 2. Institute of Cardiology in Warsaw, Poland. 3. Division of Cardiovascular Imaging, Department of Radiology and Radiological Science, Medical University of South Carolina, Charleston, SC, USA; Division of Cardiology, Department of Medicine, Medical University of South Carolina, Charleston, SC, USA. 4. Division of Cardiovascular Imaging, Department of Radiology and Radiological Science, Medical University of South Carolina, Charleston, SC, USA.
Abstract
BACKGROUND: The aim of this prospective, randomized trial was to evaluate whether the use of coronary computed tomography angiography (CCTA) as the first-line anatomical test in patients with suspected significant coronary artery disease (CAD) may reduce the number of coronary invasive angiographies (ICA), and expand the use of CCTA in patients currently diagnosed invasively. METHODS:120 patients (age:60.6 ± 7.9 years, 35% female) with indications to ICA were randomized 1:1 to undergo CCTA versus direct ICA. Outcomes were evaluated during the diagnostic and therapeutic periods. RESULTS: The number of invasively examined patients was reduced by 64.4% in the CCTA group as compared to the direct ICA group (21vs59,p < 0.0001). The number of patients with ICAs not followed by coronary intervention was reduced by 88.1% with the CCTA strategy (5vs42,p < 0.0001). Over the diagnostic and therapeutic course there were no significant differences regarding the median volume of contrast (CCTA 80.3 ml[65.0-165.0] vs ICA 90.0 ml[55.0-100.0], p = 0.099), while a non-significant trend towards higher radiation dose in the CCTA group was observed (9.9 mSv[7.0-22.1] vs 9.4 mSv[5.2-14.0], p = 0.05). There were no acute cardiovascular events. CONCLUSIONS:CCTA may hypothetically act as an effective 'gatekeeper' to the catheterization laboratory in the diagnosis of stable patients with current indications for ICA. This strategy may result in non-invasive, outpatient-based triage of two thirds of individuals without actionable CAD, obviating unnecessary invasive examinations. However, the longer follow-up is indispensable. CLINICALTRIALS. GOV NUMBER: NCT02591992.
RCT Entities:
BACKGROUND: The aim of this prospective, randomized trial was to evaluate whether the use of coronary computed tomography angiography (CCTA) as the first-line anatomical test in patients with suspected significant coronary artery disease (CAD) may reduce the number of coronary invasive angiographies (ICA), and expand the use of CCTA in patients currently diagnosed invasively. METHODS: 120 patients (age:60.6 ± 7.9 years, 35% female) with indications to ICA were randomized 1:1 to undergo CCTA versus direct ICA. Outcomes were evaluated during the diagnostic and therapeutic periods. RESULTS: The number of invasively examined patients was reduced by 64.4% in the CCTA group as compared to the direct ICA group (21vs59,p < 0.0001). The number of patients with ICAs not followed by coronary intervention was reduced by 88.1% with the CCTA strategy (5vs42,p < 0.0001). Over the diagnostic and therapeutic course there were no significant differences regarding the median volume of contrast (CCTA 80.3 ml[65.0-165.0] vs ICA 90.0 ml[55.0-100.0], p = 0.099), while a non-significant trend towards higher radiation dose in the CCTA group was observed (9.9 mSv[7.0-22.1] vs 9.4 mSv[5.2-14.0], p = 0.05). There were no acute cardiovascular events. CONCLUSIONS:CCTA may hypothetically act as an effective 'gatekeeper' to the catheterization laboratory in the diagnosis of stable patients with current indications for ICA. This strategy may result in non-invasive, outpatient-based triage of two thirds of individuals without actionable CAD, obviating unnecessary invasive examinations. However, the longer follow-up is indispensable. CLINICALTRIALS. GOV NUMBER: NCT02591992.
Authors: Sakura Nagumo; Carlos Collet; Bjarne L Norgaard; Hiromasa Otake; Brian Ko; Bon-Kwon Koo; Jonathon Leipsic; Daniele Andreini; Ward Heggermont; Jesper M Jensen; Yu Takahashi; Abdul Ihdayhid; Zinlong Zhang; Emanuele Barbato; Michael Maeng; Takuya Mizukami; Jozef Bartunek; Adam Updegrove; Martin Penicka; Campbell Rogers; Charles Taylor; Bernard De Bruyne; Jeroen Sonck Journal: Clin Cardiol Date: 2021-03-03 Impact factor: 2.882