Individuals Who Have Diabetes and Advanced Coronary Artery Disease Have Significantly Better Outcomes with Bypass Surgery than Angioplasty
Highly-anticipated FREEDOM Trial establishes gold standard for treatment of high-risk patient population.
An international team of researchers led by Valentin Fuster, MD, PhD, Director of Mount Sinai Heart, has found in the first long-term study of its kind that individuals who have diabetes and advanced coronary artery disease (CAD) live longer and are less likely to suffer a non-fatal heart attack when treated with bypass surgery instead of angioplasty. The results from this long-awaited research are published Online First on the New England Journal of Medicine website and were presented today at the American Heart Association Scientific Sessions 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.
The Mount Sinai Medical Center is among the world's leading centers for cardiovascular medicine, ranking in the "Top 10" in Cardiology and Heart Surgery by U.S. News and World Report's "Best Hospitals" list. It offers advanced diagnostic and therapeutic technologies to care for heart patients of all ages — from before birth to the end of life—while serving one of the most diverse patient populations in the world. Mount Sinai's comprehensive approach integrates the latest techniques, including nanomedicine and sub-cellular medicine, genetics, and advanced imaging. World-class clinical research conducted onsite aims to speed discoveries from the laboratory to benefit all patients with cardiovascular disease.
The FREEDOM trial is supported by U01 grant HL071988 and HL092989 from the National Heart, Lung, and Blood Institute (NHLBI), a part of the National Institutes of Health (NIH).
About The Mount Sinai Medical Center
The Mount Sinai Medical Center encompasses both The Mount Sinai Hospital and Mount Sinai School of Medicine. Established in 1968, Mount Sinai School of Medicine is one of the leading medical schools in the United States. The Medical School is noted for innovation in education, biomedical research, clinical care delivery, and local and global community service. It has more than 3,400 faculty in 32 departments and 14 research institutes, and ranks among the top 20 medical schools both in National Institutes of Health (NIH) funding and by U.S. News & World Report.
The Mount Sinai Hospital, founded in 1852, is a 1,171-bed tertiary- and quaternary-care teaching facility and one of the nation's oldest, largest and most-respected voluntary hospitals. In 2012, U.S. News & World Report ranked The Mount Sinai Hospital 14th on its elite Honor Roll of the nation's top hospitals based on reputation, safety, and other patient-care factors. Mount Sinai is one of 12 integrated academic medical centers whose medical school ranks among the top 20 in NIH funding and U.S. News & World Report and whose hospital is on the U.S. News & World Report Honor Roll. Nearly 60,000 people were treated at Mount Sinai as inpatients last year, and approximately 560,000 outpatient visits took place.
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