CHICAGO – Optimal guideline-directed medical therapy appears more important than routine coronary CT screening in preventing death and cardiac events in patients with diabetes at high risk for asymptomatic coronary artery disease, the FACTOR-64 trial suggests.
At an average follow-up of 4 years, routine coronary computed tomography angiography (CCTA) failed to significantly reduce the primary composite endpoint of all-cause mortality, nonfatal myocardial infarction, or hospitalization for unstable angina, compared with medical management in the intent-to-treat analysis (6.2% vs. 7.6%, respectively; hazard ratio, 0.80; P = .38).
Event rates were also similar between groups in the as-treated analysis (5.6% vs. 7.9%; HR, 0.69; P = .16), study author Dr. Joseph Brent Muhlestein reported at the American Heart Association scientific sessions.
These findings do not support CCTA screening in this population,” he said.
CCTA screening, however, did reveal coronary artery disease in 70% of patients, prompting a recommendation for additional diagnostics and/or more aggressive management of risk factors. This resulted in modest but significant improvements in lipid subfractions and blood pressure levels in the CCTA group and coronary revascularization procedures in 5.8%, Dr. Muhlestein, with the Intermountain Heart Institute in Murray, Utah, said.
FACTOR-64 randomized 900 patients with type 1 or 2 diabetes for at least 3-5 years and without CAD symptoms to 64-slice CCTA screening or standard guideline-based optimal diabetes care including a target hemoglobin A1c level of less than 7.0%, LDL cholesterol level below 100 mg/dL, and systolic BP less than 130 mm Hg. Based on CCTA findings, recommendations were made for standard or aggressive therapy (HbA1c below 6.0%, LDL cholesterol under 70 mg/dL, HDL cholesterol greater than 50 mg/dL in women or above 40 mg/dL in men, triglycerides below 150 mg/dL, and systolic BP under 120 mm Hg) or aggressive therapy with invasive angiography. All patients were recruited from the Intermountain Healthcare system in Utah. Their mean age was 61 years.
The secondary composite endpoint of cardiovascular death, nonfatal myocardial infarction, or hospitalization for unstable angina was similar between the CCTA and control groups analyzed by intention to treat (4.6% vs. 5.1%, respectively; HR, 0.89; P = .70) and as-treated (4.1% vs. 5.6%; HR, 0.72; P = .30), according to the results, published online simultaneously (JAMA 2014 Nov. 17 [doi: 10.1001/jama.2014.15825]).
Continued on next page >>