FREEDOM results announced

Published on November 8, 2012 at 9:15 AM · No Comments

By Piriya Mahendra, medwireNews Reporter

Results from the FREEDOM trial show that coronary artery bypass graft surgery (CABG) significantly reduces the risk for adverse outcomes compared with percutaneous coronary intervention (PCI) in patients with diabetes and coronary artery disease (CAD).

However, Valentin Fuster (Mount Sinai School of Medicine, New York, USA) and team also reported at the annual meeting of the American Heart Association in Los Angeles, California, USA that the 5-year incidence of stroke was higher in patients who underwent CABG than in those who underwent PCI, at 5.2% versus 2.4%.

The authors say that the benefit of CABG was driven by significant differences between the groups in the rate of MI and death from any cause. They also point out that this result was similar at all levels of angiographic complexity (according to the SYNTAX score), ejection fraction, and renal function.

This randomized trial of 1900 patients with diabetes and multivessel CAD showed that the primary composite outcome of death from any cause, nonfatal myocardial infarction (MI), and nonfatal stroke at 5 years occurred significantly less frequently in CABG than PCI patients, at 18.7% versus 26.6%.

Fuster and team remark that although the National Heart, Lung, and Blood Institute recommended that CABG was the treatment method of choice in diabetic and CAD patients in the wake of results from the Bypass Angioplasty Revascularization Investigation (BARI) in the 1990s, clinical practice has not changed appreciably.

"When considered together, the data provide a convincing signal that PCI results in increased long-term mortality, as compared with CABG, in patients with diabetes and multivessel CAD," they write in the New England Journal of Medicine.

In a related editorial, Mark Hlatky (Stanford University School of Medicine, California, USA) says: "As a cardiologist who does not perform either procedure, I find that the FREEDOM (Future Revascularization Evaluation in Patients with Diabetes Mellitus: Optimal Management of Multivessel Disease) trial provides compelling evidence of the comparative effectiveness of CABG versus PCI in patients with diabetes and multivessel coronary artery disease."

He continues: "The results of the FREEDOM trial suggest that patients with diabetes ought to be informed about the potential survival benefit from CABG for the treatment of multivessel disease. These discussions should begin before coronary angiography in order to provide enough time for the patient to digest the information, discuss it with family members and members of the heart team, and come to an informed decision."

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