The Future REvascularization Evaluation in patients with Diabetes mellitus: optimal management of Multivessel disease (FREEDOM) trial: clinical and angiographic profile at study entry.
BACKGROUND
The optimal revascularization strategy for diabetic patients with multivessel coronary artery disease (MVD) remains uncertain for lack of an adequately powered, randomized trial. The FREEDOM trial was designed to compare contemporary coronary artery bypass grafting (CABG) to percutaneous coronary intervention (PCI) with drug-eluting stents in diabetic patients with MVD against a background of optimal medical therapy.


METHODS
A total of 1,900 diabetic participants with MVD were randomized to PCI or CABG worldwide from April 2005 to March 2010. FREEDOM is a superiority trial with a mean follow-up of 4.37 years (minimum 2 years) and 80% power to detect a 27.0% relative reduction. We present the baseline characteristics of patients screened and randomized, and provide a comparison with other MVD trials involving diabetic patients.


RESULTS
The randomized cohort was 63.1 ± 9.1 years old and 29% female, with a median diabetes duration of 10.2 ± 8.9 years. Most (83%) had 3-vessel disease and on average took 5.5 ± 1.7 vascular medications, with 32% on insulin therapy. Nearly all had hypertension and/or dyslipidemia, and 26% had a prior myocardial infarction. Mean hemoglobin A1c was 7.8 ± 1.7 mg/dL, 29% had low-density lipoprotein <70 mg/dL, and mean systolic blood pressure was 134 ± 20 mm Hg. The mean SYNTAX score was 26.2 with a symmetric distribution. FREEDOM trial participants have baseline characteristics similar to those of contemporary multivessel and diabetes trial cohorts.


CONCLUSIONS
The FREEDOM trial has successfully recruited a high-risk diabetic MVD cohort. Follow-up efforts include aggressive monitoring to optimize background risk factor control. FREEDOM will contribute significantly to the PCI versus CABG debate in diabetic patients with MVD.
Mount Sinai School of Medicine, New York, NY 10029-6574, USA.
Sameer
S
Bansilal
Michael E
ME
Farkouh
Whady
W
Hueb
May
M
Ogdie
George
G
Dangas
Alexandra J
AJ
Lansky
David J
DJ
Cohen
Elizabeth A
EA
Magnuson
Krishnan
K
Ramanathan
Jean-Francois
JF
Tanguay
Victoria
V
Muratov
Lynn A
LA
Sleeper
Michael
M
Domanski
Michel E
ME
Bertrand
Valentin
V
Fuster
D044362:Australasia; D001026:Coronary Artery Bypass; D003324:Coronary Artery Disease / Q000473:pathology / Q000601:surgery*; D003924:Diabetes Mellitus, Type 2 / Q000150:complications / Q000188:drug therapy / Q000453:epidemiology; D003925:Diabetic Angiopathies / Q000473:pathology / Q000601:surgery*; D054855:Drug-Eluting Stents; D005060:Europe; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000517:prevention & control; D009656:North America; D013020:South America; D020521:Stroke / Q000517:prevention & control