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FACTOR-64: CCTA screening for CAD failed to reduce 4-year events in diabetes patients
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CHICAGO — Screening for CAD by coronary computed tomography angiography did not reduce the composite rate of all-cause mortality, nonfatal MI or hospitalization for unstable angina at 4 years in asymptomatic patients with diabetes, despite use of coronary interventions and favorable trends in lipids and BP.
Prior attempts at screening for asymptomatic CAD had been limited to noninvasive tests with variable sensitivity and specificity that were capable of identifying only obstructive CAD causing myocardial ischemia, according to Joseph B. Muhlestein, MD, from Intermountain Medical Center Heart Institute in Murray, Utah, and University of Utah School of Medicine.
Joseph B. Muhlestein
This led to Muhlestein and fellow researchers for the FACTOR-64 trial to assess whether routine screening for CAD by coronary computed tomography angiography (CCTA) in patients with type 1 and type 2 diabetes who are at high cardiac risk, followed by CCTA-directed therapy, would reduce CV risk.
For the trial, researchers enrolled 900 patients with a diabetes duration of at least 3 to 5 years and no CAD symptoms. Patients were recruited from 45 clinics and practices in a single health care system in Utah and enrolled from July 9, 2007, through May 16, 2013, at a single coordinating center.
The researchers randomly assigned patients in a 1:1 ratio to CCTA screening for CAD (n=452) or diabetes care based on standard national guidelines (control group; n=448).
Follow-up procedures included coronary stress/noninvasive imaging testing, diagnostic coronary angiography, PCI and CABG. Although the rate of patients who underwent follow-up procedures was fairly low in the overall group, “it was increased in the patients who underwent screening,” Muhlestein said during a press conference.
Patients were followed for a mean of 4 years.
The primary endpoint — a composite of all-cause mortality, nonfatal MI and hospitalization for unstable angina — was 7.6% (1.9% per year) in the control group vs. 6.2% (1.6% per year) in the CCTA group (HR=0.8; P=.38), which was lower than the expected annual event rate of 8% per year, according to Muhlestein.
“This may be attributed to the excellent medical management received by all enrollees … with baseline levels near or exceeding system targets,” Muhlestein said.
Additionally, rates of CV MACE (control, 5.1% vs. CCTA, 4.6%; HR= 0.86; P=.76), ischemic MACE (control, 3.8% vs. CCTA, 4.4%; HR=1.15; P=.68) and stroke/carotid revascularization procedures (control, 2% vs. CCTA, 1.8%; HR=0.85; P=0.73) were not significantly different between groups. However, hospitalization for HF was lower in the CCTA group (0.7% vs. 2.2%; HR=0.26; P=.04).
Muhlestein concluded that these findings do not support CCTA screening for asymptomatic patients. – by Brian Ellis
For more information:
Muhlestein JP. LBCT.02: Anti-Lipid Therapy and Prevention of CAD. Presented at: American Heart Association Scientific Sessions; Nov. 15-19, 2014; Chicago.
Muhlestein JB. JAMA. 2014;doi:10.1001/jama.2014.15825.
Disclosure: Muhlestein reports no relevant financial disclosures.