TY - JOUR
T1 - Combined strategy of upfront CTCA and optimal treatment for stable chest pain
T2 - rationale and design of the CLEAR-CAD trial
AU - Verpalen, Victor A.
AU - Coerkamp, Casper F.
AU - Hinderks, Mark J.
AU - Meeder, Joan G.
AU - Winter, Michiel M.
AU - Arkenbout, E. Karin
AU - Vis, Jeroen C.
AU - Habets, Jesse
AU - Smulders, Martijn W.
AU - Mihl, Casper
AU - van Ofwegen-Hanekamp, Clara E. E.
AU - van der Spoel, Tycho I. G.
AU - Tanis, Wilco
AU - van Gelder, Rogier E.
AU - van der Wielen, Marloes L. J.
AU - Somsen, G. Aernout
AU - Kikkert, Wouter J.
AU - Carati, Luc F.
AU - el Barzouhi, Abdelilah
AU - van Bergen, Paul F. M. M.
AU - Dedic, Admir
AU - Prokop, Mathias
AU - Stallmann, Hein P.
AU - Beele, Xavier D. Y.
AU - van Ufford, Henriette M. E. Quarles
AU - Nijveldt, Robin
AU - Dijkgraaf, Marcel G. W.
AU - Damman, Peter
AU - Planken, R. Nils
AU - Henriques, Jose P. S.
AU - CLEAR CAD Investigators
PY - 2024/11
Y1 - 2024/11
N2 - BackgroundPatients with stable chest pain suspected of coronary artery disease (CAD) usually undergo multiple diagnostic tests to confirm or rule out obstructive CAD. Some tests may not effectively assess the presence of CAD, precluding optimal treatment. A diagnostic strategy of upfront computed tomography coronary angiography (CTCA) combined with optimal medical therapy (OMT) tailored to the extent of CAD may be superior to standard care in preventing major adverse cardiac events.Study designThe CLEAR-CAD trial is a prospective, open-label, multicentre, randomised, superiority trial of an upfront CTCA-guided strategy in 6444 patients presenting in an outpatient setting with suspected CAD compared with standard care, in approximately 30 participating centres in the Netherlands. The upfront CTCA-guided strategy consists of an initial CTCA which is assessed using the Coronary Artery Disease-Reporting and Data System (CAD-RADS 2.0). In patients without CAD (CAD-RADS 0) no specific cardiac medication is mandated. Patients with non-obstructive CAD (CAD-RADS 1-2) are treated with preventive OMT. Patients with obstructive CAD (CAD-RADS >= 3) are treated with preventive and anti-anginal OMT; in the presence of pharmacologically refractory symptoms patients undergo selective revascularisation after non-invasive functional imaging for myocardial ischaemia (>= 10%). Patients with significant left main or proximal left anterior descending coronary artery stenosis on CTCA undergo direct invasive coronary angiography and subsequent revascularisation. The primary endpoint is the composite of all-cause death and myocardial infarction.ConclusionThe CLEAR-CAD trial is the first randomised study to investigate the efficacy of a combined upfront CTCA-guided medical and selective revascularisation strategy in an outpatient setting with suspected CAD compared with standard care.
AB - BackgroundPatients with stable chest pain suspected of coronary artery disease (CAD) usually undergo multiple diagnostic tests to confirm or rule out obstructive CAD. Some tests may not effectively assess the presence of CAD, precluding optimal treatment. A diagnostic strategy of upfront computed tomography coronary angiography (CTCA) combined with optimal medical therapy (OMT) tailored to the extent of CAD may be superior to standard care in preventing major adverse cardiac events.Study designThe CLEAR-CAD trial is a prospective, open-label, multicentre, randomised, superiority trial of an upfront CTCA-guided strategy in 6444 patients presenting in an outpatient setting with suspected CAD compared with standard care, in approximately 30 participating centres in the Netherlands. The upfront CTCA-guided strategy consists of an initial CTCA which is assessed using the Coronary Artery Disease-Reporting and Data System (CAD-RADS 2.0). In patients without CAD (CAD-RADS 0) no specific cardiac medication is mandated. Patients with non-obstructive CAD (CAD-RADS 1-2) are treated with preventive OMT. Patients with obstructive CAD (CAD-RADS >= 3) are treated with preventive and anti-anginal OMT; in the presence of pharmacologically refractory symptoms patients undergo selective revascularisation after non-invasive functional imaging for myocardial ischaemia (>= 10%). Patients with significant left main or proximal left anterior descending coronary artery stenosis on CTCA undergo direct invasive coronary angiography and subsequent revascularisation. The primary endpoint is the composite of all-cause death and myocardial infarction.ConclusionThe CLEAR-CAD trial is the first randomised study to investigate the efficacy of a combined upfront CTCA-guided medical and selective revascularisation strategy in an outpatient setting with suspected CAD compared with standard care.
KW - Coronary artery disease
KW - Computed tomography coronary angiography
KW - Optimal medical therapy
KW - Non-invasive functional imaging
KW - Revascularisation
KW - CORONARY-ARTERY-DISEASE
KW - MULTICENTER
KW - ANGIOGRAPHY
KW - TOMOGRAPHY
KW - HISTORY
KW - ANGINA
KW - HEART
KW - RISK
U2 - 10.1007/s12471-024-01906-3
DO - 10.1007/s12471-024-01906-3
M3 - Article
SN - 1568-5888
VL - 32
SP - 387
EP - 396
JO - Netherlands Heart Journal
JF - Netherlands Heart Journal
IS - 11
ER -