The Future REvascularization Evaluation in patients with Diabetes mellitus: optimal management of Multivessel disease (FREEDOM) trial: clinical and angiographic profile at study entry

Sameer Bansilal, Michael E Farkouh, Whady Hueb, May Ogdie, George Dangas, Alexandra J Lansky, David J Cohen, Elizabeth A Magnuson, Krishnan Ramanathan, Jean-Francois Tanguay, Victoria Muratov, Lynn A Sleeper, Michael Domanski, Michel E Bertrand, Valentin Fuster, Sameer Bansilal, Michael E Farkouh, Whady Hueb, May Ogdie, George Dangas, Alexandra J Lansky, David J Cohen, Elizabeth A Magnuson, Krishnan Ramanathan, Jean-Francois Tanguay, Victoria Muratov, Lynn A Sleeper, Michael Domanski, Michel E Bertrand, Valentin Fuster

Abstract

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.

Trial registration: ClinicalTrials.gov NCT00086450.

Copyright © 2012 Mosby, Inc. All rights reserved.

Figures

Figure 1
Figure 1
FREEDOM Trial Design
Figure 2
Figure 2
EuroSCORE Distribution for FREEDOM Subjects at Randomization (N=1857)
Figure 3
Figure 3
Syntax Score Distribution for FREEDOM Subjects at Randomization (N=1887)
Figure 4
Figure 4
Comparison of Contemporary Trials
Figure 5
Figure 5
Comparison of Evidence-Based Medication Use Across Trials

Source: PubMed

Sponsor e collaboratori

Condizioni mediche

Interventi farmacologici

3
Sottoscrivi