FREEDOM: Insulin Status Affects Revascularization Outcomes in Diabetic Patients

San Francisco, CA—An analysis of the FREEDOM trial indicated higher rates of MACE at 5 years after revascularization among patients with diabetes who were treated with insulin compared with those who did not receive insulin therapy, according to a presentation at TCT 2013.

George D. Dangas, MD, PhD, of Mount Sinai Medical Center, New York, presented results of a subgroup analysis based on insulin treatment of the 1,850 patients with diabetes and multivessel disease in the FREEDOM trial who were randomly assigned to CABG (n=894) or PCI with a first-generation DES (n=956). Of those, 602 had received insulin therapy with or without oral antidiabetes medication at baseline (DES, n=325; CABG, n= 277) and 1,248 received no insulin therapy (DES, n=631 vs. CABG, n=617).
Results at 5 years

At 5 years, the primary endpoint of MACE — a composite of death, stroke and MI —was higher in those who received insulin than in those who did not (see Figure). Regardless of insulin status, the estimated percentage of MACE after 5 years was higher among diabetic patients assigned to DES (insulin, 32.2% vs. no insulin, 23.2%) compared with CABG (insulin, 24.3% vs. no insulin, 15.6%). Stroke rates were higher among patients assigned CABG regardless of insulin use (CABG, 7.5% vs. DES, 3.7%) or no insulin use (CABG, 4.3% vs. DES, 1.7%).

“In patients with diabetes and multivessel CAD, there was more MACE in patients treated with insulin than in those not treated with insulin, but the differences in clinical outcomes between CABG and DES were maintained regardless of the presence or absence of insulin treatment,” Dangas said.

Patients treated with insulin were more likely to be female (38.7% vs. 23.5%), heavier (BMI, 30.5 g/m2 vs. 29.3 g/m2), have a longer duration of diabetes (15.1 years vs. 7.7 years), have an elevated HbA1c (8.5% vs. 7.5%), and have a history of hypertension (87.5% vs. 83.2%), congestive HF (32.1% vs. 24.3%) and ACS (35.1% vs. 28.6%).

Data from the main FREEDOM trial, published in The New England Journal of Medicine last year, demonstrated that CABG was superior to PCI for rates of death and MI and was associated with a higher risk for stroke.



Dangas reports no relevant conflicts of interest.