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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.

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posted on 17.11.2016, 15:00 by J. P. Greenwood, D. P. Ripley, C. Berry, Gerry P. McCann, S. Plein, C. Bucciarelli-Ducci, E. Dall'Armellina, A. Prasad, P. Bijsterveld, J. R. Foley, K. Mangion, M. Sculpher, S. Walker, C. C. Everett, D. A. Cairns, L. D. Sharples, J. M. Brown, CE-MARC 2 Investigators
IMPORTANCE: Among patients with suspected coronary heart disease (CHD), rates of invasive angiography are considered too high. OBJECTIVE: To test the hypothesis that among patients with suspected CHD, cardiovascular magnetic resonance (CMR)-guided care is superior to National Institute for Health and Care Excellence (NICE) guidelines-directed care and myocardial perfusion scintigraphy (MPS)-guided care in reducing unnecessary angiography. DESIGN, SETTING, AND PARTICIPANTS: Multicenter, 3-parallel group, randomized clinical trial using a pragmatic comparative effectiveness design. From 6 UK hospitals, 1202 symptomatic patients with suspected CHD and a CHD pretest likelihood of 10% to 90% were recruited. First randomization was November 23, 2012; last 12-month follow-up was March 12, 2016. INTERVENTIONS: Patients were randomly assigned (240:481:481) to management according to UK NICE guidelines or to guided care based on the results of CMR or MPS testing. MAIN OUTCOMES AND MEASURES: The primary end point was protocol-defined unnecessary coronary angiography (normal fractional flow reserve >0.8 or quantitative coronary angiography [QCA] showing no percentage diameter stenosis ≥70% in 1 view or ≥50% in 2 orthogonal views in all coronary vessels ≥2.5 mm diameter) within 12 months. Secondary end points included positive angiography, major adverse cardiovascular events (MACEs), and procedural complications. RESULTS: Among 1202 symptomatic patients (mean age, 56.3 years [SD, 9.0]; women, 564 [46.9%] ; mean CHD pretest likelihood, 49.5% [SD, 23.8%]), number of patients with invasive coronary angiography after 12 months was 102 in the NICE guidelines group (42.5% [95% CI, 36.2%-49.0%])], 85 in the CMR group (17.7% [95% CI, 14.4%-21.4%]); and 78 in the MPS group (16.2% [95% CI, 13.0%-19.8%]). Study-defined unnecessary angiography occurred in 69 (28.8%) in the NICE guidelines group, 36 (7.5%) in the CMR group, and 34 (7.1%) in the MPS group; adjusted odds ratio of unnecessary angiography: CMR group vs NICE guidelines group, 0.21 (95% CI, 0.12-0.34, P < .001); CMR group vs the MPS group, 1.27 (95% CI, 0.79-2.03, P = .32). Positive angiography proportions were 12.1% (95% CI, 8.2%-16.9%; 29/240 patients) for the NICE guidelines group, 9.8% (95% CI, 7.3%-12.8%; 47/481 patients) for the CMR group, and 8.7% (95% CI, 6.4%-11.6%; 42/481 patients) for the MPS group. A MACE was reported at a minimum of 12 months in 1.7% of patients in the NICE guidelines group, 2.5% in the CMR group, and 2.5% in the MPS group (adjusted hazard ratios: CMR group vs NICE guidelines group, 1.37 [95% CI, 0.52-3.57]; CMR group vs MPS group, 0.95 [95% CI, 0.46-1.95]). CONCLUSIONS AND RELEVANCE: In patients with suspected angina, investigation by CMR resulted in a lower probability of unnecessary angiography within 12 months than NICE guideline-directed care, with no statistically significant difference between CMR and MPS strategies. There were no statistically significant differences in MACE rates. TRIAL REGISTRATION: Clinicaltrials.gov Identifier: NCT01664858.

Funding

This trial was funded by grant SP/12/1/29062 and fellowships FS/15/54/31639 (Dr Mangion) and FS/1062/28409 (Dr Plein) from the British Heart Foundation; the Leeds Teaching Hospital Charitable Foundation and the National Institute for Health Research (NIHR), through the Local Clinical Research Networks and the Leeds Clinical Research Facility; the NIHR Biomedical Research Unit in Cardiovascular Disease at the University Hospitals Bristol National Health Service Foundation Trust and the University of Bristol (Dr Bucciarelli-Ducci); by a senior fellowship from the Scottish Funding Council and grant RE/13/5/30177 from the British Heart Foundation Centre of Research Excellence award (Dr Berry); and by NIHR postdoctoral and career development fellowships (Dr McCann).

History

Citation

Journal of the American Medical Association (JAMA), 2016, 316 (10), pp. 1051-1060

Author affiliation

/Organisation/COLLEGE OF MEDICINE, BIOLOGICAL SCIENCES AND PSYCHOLOGY/School of Medicine/Department of Cardiovascular Sciences

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VoR (Version of Record)

Published in

Journal of the American Medical Association (JAMA)

Publisher

American Medical Association (AMA):

issn

0098-7484

eissn

1538-3598

Available date

01/03/2017

Publisher version

http://jamanetwork.com/journals/jama/fullarticle/2546718

Language

en

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