Design of the Future REvascularization Evaluation in patients with Diabetes mellitus: Optimal management of Multivessel disease (FREEDOM) Trial - 09/08/11
, George Dangas, MD, PhD b, Martin B. Leon, MD b, Craig Smith, MD b, Richard Nesto, MD c, John B. Buse, MD, PhD d, David J. Cohen, MD, MSc e, Elizabeth Mahoney, ScD e, Lynn Sleeper, ScD h, Spencer King, MD f, Michael Domanski, MD g, Sonja McKinlay, PhD h, Valentin Fuster, MD, PhD aRésumé |
Background |
Prior randomized trials suggested that revascularization of diabetic patients by coronary artery bypass grafting (CABG) produced results superior to balloon angioplasty. The introduction of drug-eluting stents (DESs) calls into question the relevance of past studies to the current era. The FREEDOM Trial is designed to determine whether CABG or percutaneous coronary intervention (PCI) is the superior approach for revascularization of diabetic patients.
Study Design |
The FREEDOM Trial is a multicenter, open-label prospective randomized superiority trial of PCI versus CABG in at least 2000 diabetic patients in whom revascularization is indicated. Consenting diabetic patients with multivessel disease will be randomized on a 1:1 basis to either CABG or multivessel stenting using DESs and observed at 30 days, 1 year, and annually for up to 5 years. At the discretion of the primary physician or interventionalists, patients randomized to the PCI/DES arm will receive any approved DESs. The primary outcome measure is the composite of all-cause mortality, nonfatal myocardial infarction, or stroke. Patients will be observed for a mean of 4 years.
Implications |
At present, coronary revascularization with CABG surgery is the treatment of choice in diabetic patients with multivessel coronary artery disease. Drug-eluting stents have shown promising preliminary results in the diabetic population. The FREEDOM Trial is an international study designed to define the optimal revascularization strategy for the diabetic patient with multivessel coronary disease.
Le texte complet de cet article est disponible en PDF.Plan
| This study was sponsored by the National Heart, Lung and Blood Institute, National Institutes of Health (Bethesda, Maryland), grant no. 5U01HL071988. |
Vol 155 - N° 2
P. 215-223 - février 2008 Retour au numéro
Article précédent
- The clinical need for high-sensitivity cardiac troponin assays for acute coronary syndromes and the role for serial testing
- Alan H.B. Wu, Allan S. Jaffe
- Aspirin and Tranexamic Acid for Coronary Artery Surgery (ATACAS) Trial: Rationale and design
- Paul S. Myles, Julian Smith, John Knight, D. James Cooper, Brendan Silbert, John McNeil, Donald S. Esmore, Brian Buxton, Henry Krum, Andrew Forbes, Andrew Tonkin, the ATACAS Trial Group
Bienvenue sur EM-consulte, la référence des professionnels de santé.
L’accès au texte intégral de cet article nécessite un abonnement.
Déjà abonné à cette revue ?