Effect of screening for coronary artery disease using CT angiography on mortality and cardiac events in high-risk patients with diabetes: the FACTOR-64 randomized clinical trial.
OBJECTIVE
Coronary artery disease (CAD) is a major cause of cardiovascular morbidity and mortality in patients with diabetes mellitus, yet CAD often is asymptomatic prior to myocardial infarction (MI) and coronary death.


OBJECTIVE
To assess whether routine screening for CAD by coronary computed tomography angiography (CCTA) in patients with type 1 or type 2 diabetes deemed to be at high cardiac risk followed by CCTA-directed therapy would reduce the risk of death and nonfatal coronary outcomes.


METHODS
The FACTOR-64 study was a randomized clinical trial in which 900 patients with type 1 or type 2 diabetes of at least 3 to 5 years' duration and without symptoms of CAD were recruited from 45 clinics and practices of a single health system (Intermountain Healthcare, Utah), enrolled at a single-site coordinating center, and randomly assigned to CAD screening with CCTA (n = 452) or to standard national guidelines-based optimal diabetes care (n = 448) (targets: glycated hemoglobin level <7.0%, low-density lipoprotein cholesterol level <100 mg/dL, systolic blood pressure <130 mm Hg). All CCTA imaging was performed at the coordinating center. Standard therapy or aggressive therapy (targets: glycated hemoglobin level <6.0%, low-density lipoprotein cholesterol level <70 mg/dL, high-density lipoprotein cholesterol level >50 mg/dL [women] or >40 mg/dL [men], triglycerides level <150 mg/dL, systolic blood pressure <120 mm Hg), or aggressive therapy with invasive coronary angiography, was recommended based on CCTA findings. Enrollment occurred between July 2007 and May 2013, and follow-up extended to August 2014.


METHODS
The primary outcome was a composite of all-cause mortality, nonfatal MI, or unstable angina requiring hospitalization; the secondary outcome was ischemic major adverse cardiovascular events (composite of CAD death, nonfatal MI, or unstable angina).


RESULTS
At a mean follow-up time of 4.0 (SD, 1.7) years, the primary outcome event rates were not significantly different between the CCTA and the control groups (6.2% [28 events] vs 7.6% [34 events]; hazard ratio, 0.80 [95% CI, 0.49-1.32]; P = .38). The incidence of the composite secondary end point of ischemic major adverse cardiovascular events also did not differ between groups (4.4% [20 events] vs 3.8% [17 events]; hazard ratio, 1.15 [95% CI, 0.60-2.19]; P = .68).


CONCLUSIONS
Among asymptomatic patients with type 1 or type 2 diabetes, use of CCTA to screen for CAD did not reduce the composite rate of all-cause mortality, nonfatal MI, or unstable angina requiring hospitalization at 4 years. These findings do not support CCTA screening in this population.


BACKGROUND
clinicaltrials.gov Identifier: NCT00488033.
Intermountain Medical Center Heart Institute, Murray, Utah2University of Utah School of Medicine, Salt Lake City.
Joseph B
JB
Muhlestein
Intermountain Medical Center Heart Institute, Murray, Utah2University of Utah School of Medicine, Salt Lake City.
Donald L
DL
Lappé
Cardiology Division, Department of Medicine, Johns Hopkins University, Baltimore, Maryland.
Joao A C
JA
Lima
Cardiology Division, Department of Medicine, Johns Hopkins University, Baltimore, Maryland.
Boaz D
BD
Rosen
Intermountain Medical Center Heart Institute, Murray, Utah.
Heidi T
HT
May
Intermountain Medical Center Heart Institute, Murray, Utah2University of Utah School of Medicine, Salt Lake City.
Stacey
S
Knight
Department of Radiology and Imaging Sciences, National Institutes of Health Clinical Center, Bethesda, Maryland.
David A
DA
Bluemke
Intermountain Medical Center Heart Institute, Murray, Utah.
Steven R
SR
Towner
Intermountain Medical Center Heart Institute, Murray, Utah.
Viet
V
Le
Intermountain Medical Center Heart Institute, Murray, Utah.
Tami L
TL
Bair
Cardiology Division, Department of Medicine, Johns Hopkins University, Baltimore, Maryland.
Andrea L
AL
Vavere
Intermountain Medical Center Heart Institute, Murray, Utah2University of Utah School of Medicine, Salt Lake City.
Jeffrey L
JL
Anderson
D000368:Aged; D000789:Angina, Unstable / Q000517:prevention & control; D017023:Coronary Angiography / Q000379:methods*; D003324:Coronary Artery Disease / Q000150:complications / Q000000981:diagnostic imaging* / Q000401:mortality; D003922:Diabetes Mellitus, Type 1 / Q000150:complications*; D003924:Diabetes Mellitus, Type 2 / Q000150:complications*; D005260:Female; D006760:Hospitalization; D006801:Humans; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000517:prevention & control; D012306:Risk; D014057:Tomography, X-Ray Computed / Q000379:methods*