Document Detail


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.
MedLine Citation:
PMID:  25402757     Owner:  NLM     Status:  Publisher    
Abstract/OtherAbstract:
Importance: 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.
Design, Setting, and Participants: 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.
Main Outcomes and Measures: 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 and Relevance: 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.
Trial Registration: clinicaltrials.gov Identifier:NCT00488033.
Authors:
Joseph B Muhlestein; Donald L Lappé; Joao A C Lima; Boaz D Rosen; Heidi T May; Stacey Knight; David A Bluemke; Steven R Towner; Viet Le; Tami L Bair; Andrea L Vavere; Jeffrey L Anderson
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Publication Detail:
Type:  JOURNAL ARTICLE     Date:  2014-11-17
Journal Detail:
Title:  JAMA     Volume:  -     ISSN:  1538-3598     ISO Abbreviation:  JAMA     Publication Date:  2014 Nov 
Date Detail:
Created Date:  2014-11-17     Completed Date:  -     Revised Date:  2014-11-18    
Medline Journal Info:
Nlm Unique ID:  7501160     Medline TA:  JAMA     Country:  -    
Other Details:
Languages:  ENG     Pagination:  -     Citation Subset:  -    
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