Early computed tomography coronary angiography in adults presenting with suspected acute coronary syndrome: the RAPID-CTCA RCT

被引:3
|
作者
Gray, Alasdair J. [1 ,2 ]
Roobottom, Carl [3 ]
Smith, Jason E. [4 ]
Goodacre, Steve [5 ]
Oatey, Katherine [6 ]
O'Brien, Rachel [2 ]
Storey, Robert F. [7 ]
Curzen, Nick [8 ]
Keating, Liza [9 ]
Kardos, Attila [10 ]
Felmeden, Dirk [11 ]
Lee, Robert J.
Thokala, Praveen
Lewis, Steff C.
Newby, David E. [12 ,13 ]
机构
[1] Univ Edinburgh, Usher Inst, Edinburgh, Midlothian, Scotland
[2] Royal Infirm Edinburgh NHS Trust, Dept Emergency Med, Edinburgh, Midlothian, Scotland
[3] Univ Hosp Plymouth NHS Trust, Dept Radiol, Plymouth, Devon, England
[4] Univ Hosp Plymouth NHS Trust, Emergency Dept, Plymouth, Devon, England
[5] Univ Sheffield, Sch Hlth & Related Res, Sheffield, S Yorkshire, England
[6] Univ Edinburgh, Usher Inst, Edinburgh Clin Trials Unit, Edinburgh, Midlothian, Scotland
[7] Univ Sheffield, Dept Infect Immun & Cardiovasc Dis, Sheffield, S Yorkshire, England
[8] Univ Southampton, Univ Hosp Southampton NHS Fdn Trust, Fac Med, Coronary Res Grp, Southampton, Hants, England
[9] Royal Berkshire NHS Fdn Trust, Dept Emergency Med, Reading, Berks, England
[10] Milton Keynes Univ Hosp, NHS Fdn Trust, Dept Cardiol, Milton Keynes, Bucks, England
[11] Torbay & South Devon NHS Fdn Trust, Dept Cardiol, Torquay, Devon, England
[12] Univ Edinburgh, Ctr Cardiovasc Sci, Edinburgh, Midlothian, Scotland
[13] Royal Infirm Edinburgh NHS Trust, Dept Cardiol, Edinburgh, Midlothian, Scotland
关键词
ACUTE CHEST-PAIN; ACUTE MYOCARDIAL-INFARCTION; EMERGENCY-DEPARTMENT; RISK STRATIFICATION; DIAGNOSTIC PERFORMANCE; COST-EFFECTIVENESS; CONTROLLED-TRIAL; ARTERY-DISEASE; PARALLEL-GROUP; HEART-DISEASE;
D O I
10.3310/IRWI5180
中图分类号
R19 [保健组织与事业(卫生事业管理)];
学科分类号
摘要
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 pound 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.
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页码:1 / 146
页数:146
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