Design of the Future REvascularization Evaluation in patients with Diabetes mellitus: Optimal management of Multivessel disease (FREEDOM) Trial

Mount Sinai School of Medicine, New York, NY 10029, USA.
American heart journal (Impact Factor: 4.46). 03/2008; 155(2):215-23. DOI: 10.1016/j.ahj.2007.10.012
Source: PubMed


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.
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.
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.

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    • "However, recent observational studies have reported that the restenosis rate with DESs was still higher in patients with DM than in those without DM.31 The FREDOM trial was designed to define the optimal revascularization strategy for diabetic patients with multi-vessel coronary disease.32 Here, we observed that the rate of TVR was higher in diabetic patients who underwent PCI than in patients undergoing CABG, although we did not evaluate the impact of diabetic coronary risk factors on in-stent restenosis. "
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    ABSTRACT: Several studies have compared the effects of coronary stenting and coronary- artery bypass grafting (CABG) on left main coronary artery (LMCA) disease. However, there are limited data on the long-term outcomes of these two interventions in diabetic patients. We evaluated 56 patients with LMCA stenosis who underwent drug-eluting stent (DES) implantation and 116 patients who underwent CABG in a single hospital in China between January 2004 and December 2006. We compared long-term major adverse cardiac events (death; a "serious outcome" composite of death, myocardial infarction, or stroke; and target-vessel revascularization). In-hospital (30-day) mortality was 0% for the DES group and 3.4% for the CABG group (p=0.31). There was no difference between the two groups in terms of risk of death [hazard ratio for stenting group, 0.49; 95% confidence interval (CI), 0.13-1.63; p=0.55] or risk of serious outcome (hazard ratio for DES group, 1.11; 95% CI, 0.39-1.45; p=0.47). The target-vessel revascularization rate was higher in the DES group than in the CABG group (hazard ratio, 3.67; 95% CI, 1.24-11.06; p=0.018). In this cohort of diabetic patients with LMCA stenosis, there was no difference in composite endpoints between patients receiving DESs and those undergoing CABG. However, stenting was associated with higher rates of target-vessel revascularization than CABG. DES implantation in diabetic patients with LMCA disease was found to be at least as safe as CABG.
    Full-text · Article · Nov 2011 · Yonsei medical journal
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    • "Therefore, it is clear that with all amount of information we have, and before the results of the FREEDOM study [51] are available, clinical judgment may be the best way to decide about the best revascularization strategy in diabetics with stable CAD and preserved LV function. Pereira et al [52] studied the ability of clinical judgment to predict the incidence of cardiovascular end-points in patients with multivessel CAD [53] and showed that when clinical decision pointed against PCI, but due to randomization patients underwent that strategy (discordant status), these patients had more composite endpoints than those in the concordant status. "
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    ABSTRACT: Diabetes mellitus is associated with well-known increases in cardiovascular morbidity and mortality. In diabetics with stable coronary artery disease, the best therapeutic option is widely discussed. Current studies comparing surgical to percutaneous revascularization have been unable to definitely demonstrate any significant advantage of one strategy over the other regarding the prevention of cardiac death or acute myocardial infarction. Therefore, even taking into account clinical and angiographic information as well as the risks determined by each type of treatment, the decision regarding the best therapeutic strategy in diabetics with stable coronary artery disease is still complex.
    Full-text · Article · Nov 2010 · Current Cardiology Reviews

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