Highly-anticipated Freedom Trial establishes gold standard for treatment of high-risk patient population.
New York, NY (PRWEB) November 04, 2012
Heart disease is the leading cause of morbidity and mortality for people with type 2 diabetes, accounting for two thirds of deaths among people with diabetes. The FREEDOM trial (Future REvascularization Evaluation in patients with Diabetes mellitus: Optimal management of Multivessel disease) is the first long-term trial designed to determine whether coronary artery bypass surgery (CABG) or percutaneous coronary intervention (PCI) with drug-eluting stents (DES), would be the superior approach to treating coronary artery disease in these individuals. The data concluded that, after five years, patients who had PCI with DES were more likely to have a cardiovascular event than those who underwent CABG.
During CABG, a healthy artery or vein from the body is connected, or grafted, to the blocked coronary artery. The grafted artery or vein bypasses the blocked portion of the coronary artery. PCI is a minimally invasive technique in which a catheter is threaded through the body, typically from an artery in the groin to a blocked or occluded vessel in the heart. The occlusion is removed and a DES is often inserted to maintain flow within the blood vessel.
Treating people with diabetes and heart disease presents unique challenges due to increased risk for death, heart attack, and stroke, said Dr. Fuster, who is also Physician-in-Chief, The Mount Sinai Medical Center, and the Richard Gorlin, MD/Heart Research Foundation Professor, Mount Sinai School of Medicine. The FREEDOM trial is the first long-term, multi-site trial that seeks to firmly establish a standard of care for this high-risk population, which includes about 25 to 30 percent of patients with CAD undergoing coronary angiography.
A total of 1,900 patients were enrolled from 2005 to 2010 at 140 international sites and randomized to undergo PCI/DES or CABG. All patients were prescribed standard medical therapy for coronary artery disease, which is aspirin and a blood thinner. At five years, 26.6 percent of patients in the PCI arm had a cardiovascular event, compared to 18.7 percent in the CABG arm.
Additionally, the researchers uncovered that the rate of all-cause mortality at five years was 16.3 percent, compared to 10.9 percent, and rate of heart attack was 13.9 percent compared to six percent, in the PCI and CABG groups, respectively. The only event that was slightly more frequent in the CABG group was stroke, at 5.2 percent compared to 2.4 percent in the PCI group.
These landmark findings provide clear evidence that CABG plus standard medical therapy is the optimal treatment path for people with diabetes and advanced coronary artery disease, said Michael Farkouh, MD, MSc, Associate Clinical Professor of Medicine (Cardiology) at Mount Sinai School of Medicine, and co-principal investigator of the FREEDOM trial. Our results indicate that while PCI is less invasive, long-term outcomes are worse. We hope clinicians worldwide will adopt this treatment paradigm to provide the best outcomes possible for their patients.
Alice Jacobs, MD, Professor of Medicine at Boston University School of Medicine, who wrote an accompanying editorial on NEJM.org, said, This well designed and executed international trial, fueled by the question of whether DES would negate the reported advantage of CABG in patients with multivessel disease and diabetes, has the potential to change clinical practice. Physicians treating patients with diabetes and complex multivessel disease may now recommend CABG as the preferred initial strategy with enthusiasm.
Other members of the Mount Sinai team participating in the FREEDOM trial are Michael Domanski, MD, Professor of Medicine (Cardiology); George Dangas, MD, Professor of Medicine (Cardiology); and Jesse Weinberger, MD, Professor of Neurology.
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Mount Sinai Researchers Find Individuals Who Have Diabetes and Advanced Coronary Artery Disease Have Significantly ...