Combined strategy of upfront CTCA and optimal treatment for stable chest pain: rationale and design of the CLEAR-CAD trial.
Computed tomography coronary angiography
Coronary artery disease
Non-invasive functional imaging
Optimal medical therapy
Revascularisation
Journal
Netherlands heart journal : monthly journal of the Netherlands Society of Cardiology and the Netherlands Heart Foundation
ISSN: 1568-5888
Titre abrégé: Neth Heart J
Pays: Netherlands
ID NLM: 101095458
Informations de publication
Date de publication:
18 Oct 2024
18 Oct 2024
Historique:
accepted:
10
09
2024
medline:
18
10
2024
pubmed:
18
10
2024
entrez:
18
10
2024
Statut:
aheadofprint
Résumé
Patients 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. The 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. The 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.
Sections du résumé
BACKGROUND
BACKGROUND
Patients 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 DESIGN
METHODS
The 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.
CONCLUSION
CONCLUSIONS
The 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.
Identifiants
pubmed: 39422833
doi: 10.1007/s12471-024-01906-3
pii: 10.1007/s12471-024-01906-3
doi:
Types de publication
Journal Article
Langues
eng
Subventions
Organisme : ZonMw
ID : 10330032010006
Pays : Netherlands
Informations de copyright
© 2024. The Author(s).
Références
Nederland Z. Verbetersignalement Pijn op de borst (verdenking) stabiele angina pectoris. 2018. https://www.zorginstituutnederland.nl/binaries/zinl/documenten/rapport/2018/01/31/zinnige-zorgverbetersignalement-%E2%80%98pijn-op-de-borst%E2%80%99/Rapport+pijn+op+de+borst.pdf ..
Neglia D, Liga R, Gimelli A, et al. Use of cardiac imaging in chronic coronary syndromes: the EURECA Imaging registry. Eur Heart J. 2023;44:142–58.
doi: 10.1093/eurheartj/ehac640
pubmed: 36452988
Knuuti J, Ballo H, Juarez-Orozco LE, et al. The performance of non-invasive tests to rule-in and rule-out significant coronary artery stenosis in patients with stable angina: a meta-analysis focused on post-test disease probability. Eur Heart J. 2018;39:3322–30.
doi: 10.1093/eurheartj/ehy267
pubmed: 29850808
Patel MR, Peterson ED, Dai D, et al. Low diagnostic yield of elective coronary angiography. N Engl J Med. 2010;362:886–95.
doi: 10.1056/NEJMoa0907272
pubmed: 20220183
pmcid: 3920593
SCOT-HEART Investigators, Newby DE, Adamson PD, Berry C, et al. Coronary CT Angiography and 5‑year risk of myocardial infarction. N Engl J Med. 2018;379:924–33.
doi: 10.1056/NEJMoa1805971
Knuuti J, Wijns W, Saraste A, et al. 2019 ESC guidelines for the diagnosis and management of chronic coronary syndromes. Eur Heart J. 2020;41:407–77.
doi: 10.1093/eurheartj/ehz425
pubmed: 31504439
SCOT-HEART investigators.. CT coronary angiography in patients with suspected angina due to coronary heart disease (SCOT-HEART): an open-label, parallel-group, multicentre trial. Lancet. 2015;385:2383–91.
doi: 10.1016/S0140-6736(15)60291-4
Williams MC, Hunter A, Shah ASV, et al. Use of coronary computed tomographic angiography to guide management of patients with coronary disease. J Am Coll Cardiol. 2016;67:1759–68.
doi: 10.1016/j.jacc.2016.02.026
pubmed: 27081014
pmcid: 4829708
DISCHARGE Trial Group:, Maurovich-Horvat P, Bosserdt M, Kofoed KF, et al. CT or invasive coronary angiography in stable chest pain. N Engl J Med. 2022;386:1591–602.
doi: 10.1056/NEJMoa2200963
Maron DJ, Hochman JS, Reynolds HR, et al. Initial invasive or conservative strategy for stable coronary disease. N Engl J Med. 2020;382:1395–407.
doi: 10.1056/NEJMoa1915922
pubmed: 32227755
pmcid: 7263833
Perera D, Clayton T, O’Kane PD, et al. Percutaneous revascularization for Ischemic left ventricular dysfunction. N Engl J Med. 2022;387:1351–60.
doi: 10.1056/NEJMoa2206606
pubmed: 36027563
Cury RC, Leipsic J, Abbara S, et al. CAD-RADS™ 2.0—2022 coronary artery disease-reporting and data system: an expert consensus document of the society of cardiovascular computed Tomography (SCCT), the American college of cardiology (ACC), the American college of radiology (ACR), and the north america society of cardiovascular imaging (NASCI). J Cardiovasc Comput Tomogr. 2022;16:536–57.
doi: 10.1016/j.jcct.2022.07.002
pubmed: 35864070
Weir-McCall JR, Williams MC, Shah ASV, et al. National trends in coronary artery disease imaging: associations with health care outcomes and costs. JACC Cardiovasc Imaging. 2023;16:659–71.
doi: 10.1016/j.jcmg.2022.10.022
pubmed: 36752441
Thygesen K, Alpert JS, Jaffe AS, et al. Fourth universal definition of myocardial infarction (2018). Circulation. 2018;138:e618–e51.
doi: 10.1161/CIR.0000000000000617
pubmed: 30571511
Diamond GA, Forrester JS. Analysis of probability as an aid in the clinical diagnosis of coronary-artery disease. N Engl J Med. 1979;300:1350–8.
doi: 10.1056/NEJM197906143002402
pubmed: 440357
Winther S, Schmidt SE, Mayrhofer T, et al. Incorporating coronary calcification into pre-test assessment of the likelihood of coronary artery disease. J Am Coll Cardiol. 2020;76:2421–32.
doi: 10.1016/j.jacc.2020.09.585
pubmed: 33213720
Woodward M, Brindle P, Tunstall-Pedoe H. Adding social deprivation and family history to cardiovascular risk assessment: the ASSIGN score from the scottish heart health extended cohort (SHHEC). Heart. 2007;93:172–6.
doi: 10.1136/hrt.2006.108167
pubmed: 17090561
Pryor DB, Shaw L, McCants CB, et al. Value of the history and physical in identifying patients at increased risk for coronary artery disease. Ann Intern Med. 1993;118:81–90.
doi: 10.7326/0003-4819-118-2-199301150-00001
pubmed: 8416322
Thorn JC, Davies CF, Brookes ST, et al. Content of health economics analysis plans (HEAPs) for trial-based economic evaluations: expert Delphi consensus survey. Value Health. 2021;24:539–47.
doi: 10.1016/j.jval.2020.10.002
pubmed: 33840432
pmcid: 8024512
Haase R, Schlattmann P, Gueret P, et al. Diagnosis of obstructive coronary artery disease using computed tomography angiography in patients with stable chest pain depending on clinical probability and in clinically important subgroups: meta-analysis of individual patient data. BMJ. 2019;365:1945.
doi: 10.1136/bmj.l1945
Douglas PS, Hoffmann U, Patel MR, et al. Outcomes of anatomical versus functional testing for coronary artery disease. N Engl J Med. 2015;372:1291–300.
doi: 10.1056/NEJMoa1415516
pubmed: 25773919
pmcid: 4473773
Min JK, Koduru S, Dunning AM, et al. Coronary CT angiography versus myocardial perfusion imaging for near-term quality of life, cost and radiation exposure: a prospective multicenter randomized pilot trial. J Cardiovasc Comput Tomogr. 2012;6:274–83.
doi: 10.1016/j.jcct.2012.06.002
pubmed: 22732201
McKavanagh P, Lusk L, Ball PA, et al. A comparison of cardiac computerized tomography and exercise stress electrocardiogram test for the investigation of stable chest pain: the clinical results of the CAPP randomized prospective trial. Eur Heart J Cardiovasc Imaging. 2015;16:441–8.
doi: 10.1093/ehjci/jeu284
pubmed: 25473041
Lubbers M, Dedic A, Coenen A, et al. Calcium imaging and selective computed tomography angiography in comparison to functional testing for suspected coronary artery disease: the multicentre, randomized CRESCENT trial. Eur Heart J. 2016;37:1232–43.
doi: 10.1093/eurheartj/ehv700
pubmed: 26746631
Dewey M, Rief M, Martus P, et al. Evaluation of computed tomography in patients with atypical angina or chest pain clinically referred for invasive coronary angiography: randomised controlled trial. BMJ. 2016;355:i5441.
doi: 10.1136/bmj.i5441
pubmed: 27777234
pmcid: 5076567
Karthikeyan G, Guzic Salobir B, Jug B, et al. Functional compared to anatomical imaging in the initial evaluation of patients with suspected coronary artery disease: An international, multi-center, randomized controlled trial (IAEA-SPECT/CTA study). J Nucl Cardiol. 2017;24:507–17.
doi: 10.1007/s12350-016-0664-3
pubmed: 27796852
Lubbers M, Coenen A, Kofflard M, et al. Comprehensive cardiac CT with myocardial perfusion imaging versus functional testing in suspected coronary artery disease: the multicenter, randomized CRESCENT-II trial. JACC Cardiovasc Imaging. 2018;11:1625–36.
doi: 10.1016/j.jcmg.2017.10.010
pubmed: 29248657
Rudziński PN, Kruk M, Kępka C, et al. The value of coronary artery computed tomography as the first-line anatomical test for stable patients with indications for invasive angiography due to suspected coronary artery disease: CAT-CAD randomized trial. J Cardiovasc Comput Tomogr. 2018;12:472–9.
doi: 10.1016/j.jcct.2018.08.004
pubmed: 30201310
Chang HJ, Lin FY, Gebow D, et al. Selective referral using CCTA versus direct referral for individuals referred to invasive coronary angiography for suspected CAD: a randomized, controlled, open-label trial. JACC Cardiovasc Imaging. 2019;12(7 Pt 2):1303–12.
doi: 10.1016/j.jcmg.2018.09.018
pubmed: 30553687
Lee SP, Seo JK, Hwang IC, et al. Coronary computed tomography angiography vs. myocardial single photon emission computed tomography in patients with intermediate risk chest pain: a randomized clinical trial for cost-effectiveness comparison based on real-world cost. Eur Heart J Cardiovasc Imaging. 2019;20:417–25.
doi: 10.1093/ehjci/jey099
pubmed: 30052964
Stillman AE, Gatsonis C, Lima JAC, et al. Coronary computed tomography angiography compared with single photon emission computed tomography myocardial perfusion imaging as a guide to optimal medical therapy in patients presenting with stable angina: the RESCUE trial. J Am Heart Assoc. 2020;9:e17993.
doi: 10.1161/JAHA.120.017993
pubmed: 33283579
pmcid: 7955393
Reis JF, Ramos RB, Marques H, et al. Cardiac computed tomographic angiography after abnormal ischemia test as a gatekeeper to invasive coronary angiography. Int J Cardiovasc Imaging. 2022;38:883–93.
doi: 10.1007/s10554-021-02426-6
pubmed: 35226221
Greenwood JP, Ripley DP, Berry C, et al. Effect of care guided by cardiovascular magnetic resonance, myocardial perfusion scintigraphy, or NICE guidelines on subsequent unnecessary Angiography rates: the CE-MARC 2 randomized clinical trial. JAMA. 2016;316:1051–60.
doi: 10.1001/jama.2016.12680
pubmed: 27570866
Morgan-Hughes G, Williams MC, Loudon M, et al. Downstream testing after CT coronary angiography: time for a rethink? Open Heart. 2021;8:e1597.
doi: 10.1136/openhrt-2021-001597
pubmed: 33622963
pmcid: 7907873