TY - JOUR
T1 - Early computed tomography coronary angiography in adults presenting with suspected acute coronary syndrome
T2 - the RAPID-CTCA RCT
AU - Gray, Alasdair J
AU - Roobottom, Carl
AU - Smith, Jason E
AU - Goodacre, Steve
AU - Oatey, Katherine
AU - O'Brien, Rachel
AU - Storey, Robert F
AU - Curzen, Nick
AU - Keating, Liza
AU - Kardos, Attila
AU - Felmeden, Dirk
AU - Lee, Robert J
AU - Thokala, Praveen
AU - Lewis, Steff C
AU - Newby, David E
N1 - Funding Information:
The research reported in this issue of the journal was funded by the HTA programme as project number 13/04/108. The contractual start date was in January 2015. The draft report began editorial review in January 2021 and was accepted for publication in February 2022. The authors have been wholly responsible for all data collection, analysis and interpretation, and for writing up their work. The HTA editors and publisher have tried to ensure the accuracy of the authors’ report and would like to thank the reviewers for their constructive comments on the draft document. However, they do not accept liability for damages or losses arising from material published in this report.
Funding Information:
This report presents independent research funded by the National Institute for Health and Care Research (NIHR). The views and opinions expressed by authors in this publication are those of the authors and do not necessarily reflect those of the NHS, the NIHR, the HTA programme or the Department of Health and Social Care. If there are verbatim quotations included in this publication the views and opinions expressed by the interviewees are those of the interviewees and do not necessarily reflect those of the authors, those of the NHS, the NIHR, the HTA programme or the Department of Health and Social Care.
Funding Information:
Declared competing interests of authors: Alasdair J Gray is a member of the National Institute for Health and Care Research (NIHR) Health Technology Assessment (HTA) Prioritisation Committee (2019–present). Steve Goodacre is the chairperson of the NIHR Clinical Trials Unit Standing Advisory Committee (2019–present). He was the deputy director of the NIHR HTA programme (2019–20); chairperson of the NIHR HTA Commissioning Committee (2019–20); and a member of the HTA Post-Funding Committee, HTA Funding Committee Policy Group and HTA Programme Oversight Committee (2019–20). Robert F Storey reports consultancy fees from Bayer (Leverkusen, Germany), Bristol-Myers Squibb/Pfizer (New York, NY, USA), AstraZeneca (Cambridge, UK), Thromboserin (Midhurst, UK), Haemonetics (Boston, MA, USA), Amgen (Thousand Oaks, CA, USA), Glycardial Diagnostics (Barcelona, Spain), Portola (South San Francisco, CA, USA), Cytosorbents (Monmouth Junction, NJ, USA), Hengrui (Princeton, NJ, USA), Sanofi Aventis (Paris, France), Idorsia (Allschwil, Switzerland) and PhaseBio (Malvern, PA, USA); honoraria from Bayer, Bristol-Myers Squibb/Pfizer, AstraZeneca, Medscape (New York, NY, USA) and Intas Pharmaceuticals (Ahmedabad, India); and institutional research grants from AstraZeneca, Thromboserin, Glycardial Diagnostics and Cytosorbents. Nick Curzen reports grants, speaker fees and travel sponsorship from Haemonetics, Boston Scientific (Marlborough, MA, USA) and HeartFlow (Redwood City, CA, USA); grants from Beckmann Coulter (Brea, CA, USA); speaker fees from Abbott (Chicago, IL, USA); travel sponsorship from Biosensors (Singapore), Edwards (Irvine, CA, USA) and Medtronic (Dublin, Ireland); and consultancy from HeartFlow, Boston Scientific, Abbott and Haemonetics. Steff C Lewis was a member of the NIHR HTA General Committee (2016–21) and was a member of the NIHR HTA Efficient Study Designs Board (2015–16). David E Newby reports unrestricted educational grants from Siemens Healthineers (Erlangen, Germany).
Publisher Copyright:
© 2022, NIHR Journals Library. All rights reserved.
PY - 2022/8/1
Y1 - 2022/8/1
N2 - BACKGROUND: Acute coronary syndrome is a common medical emergency. The optimal strategy to investigate patients who are at intermediate risk of acute coronary syndrome has not been fully determined.OBJECTIVE: To investigate the role of early computed tomography coronary angiography in the investigation and treatment of adults presenting with suspected acute coronary syndrome.DESIGN: A prospective, multicentre, open, parallel-group randomised controlled trial with blinded end-point adjudication.SETTING: Thirty-seven hospitals in the UK.PARTICIPANTS: Adults (aged ≥ 18 years) presenting to the emergency department, acute medicine services or cardiology department with suspected or provisionally diagnosed acute coronary syndrome and at least one of the following: (1) a prior history of coronary artery disease, (2) a cardiac troponin level > 99th centile and (3) an abnormal 12-lead electrocardiogram.INTERVENTIONS: Early computed tomography coronary angiography in addition to standard care was compared with standard care alone. Participants were followed up for 1 year.MAIN OUTCOME MEASURE: One-year all-cause death or subsequent type 1 (spontaneous) or type 4b (stent thrombosis) myocardial infarction, measured as the time to such event adjudicated by two cardiologists blinded to the computerised tomography coronary angiography ( CTCA ) arm. Cost-effectiveness was estimated as the lifetime incremental cost per quality-adjusted life-year gained.RESULTS: Between 23 March 2015 and 27 June 2019, 1748 participants [mean age 62 years (standard deviation 13 years), 64% male, mean Global Registry Of Acute Coronary Events score 115 (standard deviation 35)] were randomised to receive early computed tomography coronary angiography (n = 877) or standard care alone (n = 871). The primary end point occurred in 51 (5.8%) participants randomised to receive computed tomography coronary angiography and 53 (6.1%) participants randomised to receive standard care (adjusted hazard ratio 0.91, 95% confidence interval 0.62 to 1.35; p = 0.65). Computed tomography coronary angiography was associated with a reduced use of invasive coronary angiography (adjusted hazard ratio 0.81, 95% confidence interval 0.72 to 0.92; p = 0.001) but no change in coronary revascularisation (adjusted hazard ratio 1.03, 95% confidence interval 0.87 to 1.21; p = 0.76), acute coronary syndrome therapies (adjusted odds ratio 1.06, 95% confidence interval 0.85 to 1.32; p = 0.63) or preventative therapies on discharge (adjusted odds ratio 1.07, 95% confidence interval 0.87 to 1.32; p = 0.52). Early computed tomography coronary angiography was associated with longer hospitalisations (median increase 0.21 days, 95% confidence interval 0.05 to 0.40 days) and higher mean total health-care costs over 1 year (£561 more per patient) than standard care.LIMITATIONS: The principal limitation of the trial was the slower than anticipated recruitment, leading to a revised sample size, and the requirement to compromise and accept a larger relative effect size estimate for the trial intervention.FUTURE WORK: The potential role of computed tomography coronary angiography in selected patients with a low probability of obstructive coronary artery disease (intermediate or mildly elevated level of troponin) or who have limited access to invasive cardiac catheterisation facilities needs further prospective evaluation.CONCLUSIONS: In patients with suspected or provisionally diagnosed acute coronary syndrome, computed tomography coronary angiography did not alter overall coronary therapeutic interventions or 1-year clinical outcomes, but it did increase the length of hospital stay and health-care costs. These findings do not support the routine use of early computed tomography coronary angiography in intermediate-risk patients with acute chest pain.TRIAL REGISTRATION: This trial is registered as ISRCTN19102565 and Clinical Trials NCT02284191.FUNDING: This project was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 26, No. 37. See the NIHR Journals Library website for further project information.
AB - BACKGROUND: Acute coronary syndrome is a common medical emergency. The optimal strategy to investigate patients who are at intermediate risk of acute coronary syndrome has not been fully determined.OBJECTIVE: To investigate the role of early computed tomography coronary angiography in the investigation and treatment of adults presenting with suspected acute coronary syndrome.DESIGN: A prospective, multicentre, open, parallel-group randomised controlled trial with blinded end-point adjudication.SETTING: Thirty-seven hospitals in the UK.PARTICIPANTS: Adults (aged ≥ 18 years) presenting to the emergency department, acute medicine services or cardiology department with suspected or provisionally diagnosed acute coronary syndrome and at least one of the following: (1) a prior history of coronary artery disease, (2) a cardiac troponin level > 99th centile and (3) an abnormal 12-lead electrocardiogram.INTERVENTIONS: Early computed tomography coronary angiography in addition to standard care was compared with standard care alone. Participants were followed up for 1 year.MAIN OUTCOME MEASURE: One-year all-cause death or subsequent type 1 (spontaneous) or type 4b (stent thrombosis) myocardial infarction, measured as the time to such event adjudicated by two cardiologists blinded to the computerised tomography coronary angiography ( CTCA ) arm. Cost-effectiveness was estimated as the lifetime incremental cost per quality-adjusted life-year gained.RESULTS: Between 23 March 2015 and 27 June 2019, 1748 participants [mean age 62 years (standard deviation 13 years), 64% male, mean Global Registry Of Acute Coronary Events score 115 (standard deviation 35)] were randomised to receive early computed tomography coronary angiography (n = 877) or standard care alone (n = 871). The primary end point occurred in 51 (5.8%) participants randomised to receive computed tomography coronary angiography and 53 (6.1%) participants randomised to receive standard care (adjusted hazard ratio 0.91, 95% confidence interval 0.62 to 1.35; p = 0.65). Computed tomography coronary angiography was associated with a reduced use of invasive coronary angiography (adjusted hazard ratio 0.81, 95% confidence interval 0.72 to 0.92; p = 0.001) but no change in coronary revascularisation (adjusted hazard ratio 1.03, 95% confidence interval 0.87 to 1.21; p = 0.76), acute coronary syndrome therapies (adjusted odds ratio 1.06, 95% confidence interval 0.85 to 1.32; p = 0.63) or preventative therapies on discharge (adjusted odds ratio 1.07, 95% confidence interval 0.87 to 1.32; p = 0.52). Early computed tomography coronary angiography was associated with longer hospitalisations (median increase 0.21 days, 95% confidence interval 0.05 to 0.40 days) and higher mean total health-care costs over 1 year (£561 more per patient) than standard care.LIMITATIONS: The principal limitation of the trial was the slower than anticipated recruitment, leading to a revised sample size, and the requirement to compromise and accept a larger relative effect size estimate for the trial intervention.FUTURE WORK: The potential role of computed tomography coronary angiography in selected patients with a low probability of obstructive coronary artery disease (intermediate or mildly elevated level of troponin) or who have limited access to invasive cardiac catheterisation facilities needs further prospective evaluation.CONCLUSIONS: In patients with suspected or provisionally diagnosed acute coronary syndrome, computed tomography coronary angiography did not alter overall coronary therapeutic interventions or 1-year clinical outcomes, but it did increase the length of hospital stay and health-care costs. These findings do not support the routine use of early computed tomography coronary angiography in intermediate-risk patients with acute chest pain.TRIAL REGISTRATION: This trial is registered as ISRCTN19102565 and Clinical Trials NCT02284191.FUNDING: This project was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 26, No. 37. See the NIHR Journals Library website for further project information.
U2 - 10.3310/IRWI5180
DO - 10.3310/IRWI5180
M3 - Article
C2 - 36062819
SN - 1366-5278
VL - 26
SP - 1
EP - 114
JO - Health Technology Assessment
JF - Health Technology Assessment
IS - 37
ER -