Abstract 11903: The FREEDOM Trial: A Snapshot at Randomization
Background: The question regarding optimal revascularization strategy for diabetic (DM) subjects with multivessel coronary artery disease (MVD) has remained unresolved for lack of an adequately powered, prospective randomized trial. To address this need, the FREEDOM trial was designed to compare a strategy of contemporary coronary artery bypass (CABG) to percutaneous intervention (PCI) with drug-eluting stents (DES) in DM patients with MVD against a background of optimal medical therapy.
Methods: The FREEDOM trial is a superiority trial with a primary endpoint composite of all-cause mortality, non-fatal MI or stroke with an expected median follow-up of 4 years. A total of 1901 subjects were randomized at 140 sites worldwide between April 2005 and March 2010. Minimum follow-up per subject is 2 years.
Results: Mean age was 63.1±9.1 years, with 29 % female, a mean duration of DM of 10.2 years and 32% receiving insulin. Almost 26% subjects had a prior MI, 3% had a prior stroke and 11% had known peripheral arterial disease. Table 1 outlines baseline risk factor results for the cohort. At randomization, 38% had uncontrolled LDL (>100 mg/dl), 64% had uncontrolled glucose levels (HbA1c>7%), 80% had uncontrolled SBP (>120 mmHg) and 47% had elevated DBP (>80 mm Hg). Almost one-third had a recent acute coronary syndrome, 26% had documented ischemia on stress testing and the remainder qualified on the basis of ischemic symptoms. Eighty-three % of subjects had 3 vessel disease and >95% had involvement of the left anterior descending artery.
Conclusions: The FREEDOM trial has successfully recruited a high-risk DM-MVD cohort and our data reflect the current state of real-world control of medical risk factors in this population. The trial protocol demands efforts towards aggressive monitoring to optimize risk factor control. In this talk we will compare the FREEDOM patient profile, including angiographic risk scores, to that of past and contemporary trial cohorts of CHD subjects.
- © 2011 by American Heart Association, Inc.