Mount Sinai Researchers Present Results of FREEDOM Trial at American Heart Association (AHA) Scientific Sessions

Released: 10-Nov-2012 12:30 PM EST
Source Newsroom: Mount Sinai Medical Center
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Newswise — Mount Sinai School of Medicine researchers presented 89 abstracts and plenary sessions at the American Heart Association’s (AHA) Scientific Sessions 2012, including the results of the FREEDOM trial, the first long-term study of its kind of individuals who have diabetes and advanced coronary artery disease (CAD).

Experts also presented research on education and medication adherence, efficacy of statin therapy in diabetes, and the use of 3D ultrasound to detect plaques in areas of the body other than the heart. The meeting took place November 4-7, 2012 in Los Angeles.

• Individuals Who Have Diabetes and Advanced Coronary Artery Disease Have Significantly Better Outcomes with Bypass Surgery than Angioplasty: The FREEDOM Trial

In the highly anticipated FREEDOM Trial, an international team of researchers led by Valentin Fuster, MD, PhD, Director of Mount Sinai Heart, found that people with diabetes and CAD live longer, and are less likely to suffer a non-fatal heart attack, when treated with bypass surgery instead of angioplasty.

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.

“Treating people with diabetes and heart disease presents unique challenges due to increased risk for death, heart attack, and stroke,” said Dr. Fuster, Physician-in-Chief, The Mount Sinai Medical Center, Director of Mount Sinai Heart, 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.”

At this year’s conference, Dr. Fuster was presented with the AHA’s 2012 Research Achievement Award for his significant and enduring contributions to a broad spectrum of cardiovascular medicine, achievements that have accelerated progress toward conquering disease and enriching the human condition worldwide.

Aggressive Statin Regimen Less Effective in Reducing Blockages in Individuals with Diabetes: Results from the YELLOW Trial

In a sub-analysis of the YELLOW (The Reduction in Yellow Plaque by Aggressive Lipid-Lowering Therapy) trial, Mount Sinai researchers evaluated 87 patients treated with a statin or standard lipid therapy. Half of the 87 patients had diabetes. After seven weeks, plaque buildup was reduced more significantly in patients without diabetes compared to patients with diabetes.

“These findings suggest that arterial plaque in people with diabetes is harder to treat and may require more intense and prolonged therapy to reduce the amount of atherosclerosis,” said Annapoorna Kini, MD, Director of the Cardiac Catheterization Laboratory and Professor of Medicine at Mount Sinai and first author on the study. “The YELLOW trial documents the beneficial effects of aggressive lipid lowering therapy in high-risk patients with coronary artery disease, but also indicates that more research is needed to identify the best treatment paradigm for people with diabetes and multivessel coronary artery disease.”

People With a Lower Education Level Do Not Adhere to Medical Therapy After Angioplasty

In a sub-analysis of PARIS (Patterns of Non-Adherence to Anti-Platelet Regimens in Stented Patients), a multicenter, prospective registry of patients that have undergone percutaneous coronary intervention (PCI) in the United States and Europe, 4,922 patients were stratified into three educational levels: people who did not graduate high school, those who did, and those who were college-educated. The primary outcome was non-adherence to antiplatelet therapy within six months.

Percutaneous coronary intervention (PCI), also known as angioplasty, is a minimally invasive procedure in which a catheter is threaded through the body, typically from an artery in the groin to a blocked vessel in the heart. The occlusion is removed and a drug-eluting stent is often inserted to maintain flow within the blood vessel. After this procedure, medical therapy consisting of a statin plus aspirin is required to maintain healthy blood flow through the stented vessel.

In the PARIS registry, nearly 13 percent of patients who did not graduate high school, 7.9 percent who did, and 7.5 percent with a college degree in the United States, did not adhere to medical therapy. In Europe, those numbers were only 3.1 percent, 2.6 percent, and 3.0 percent, respectively.

“These findings indicate an unmet need for ongoing heart health awareness and consultations among less-educated patients in the United States,” said lead researcher, Roxana Mehran, MD, Professor of Medicine (Cardiology) and Health Evidence and Policy, and Director of Interventional Cardiovascular Research and Clinical Trials at Mount Sinai School of Medicine.“ Clinicians and patient advocacy organizations should work together to identify tools to help promote medication adherence.”

Novel 3D Ultrasound Technique Improves Detection of Systemic Vascular Disease: The High-Risk Plaque Initiative

The burden of atherosclerosis is usually assessed by examining one specific anatomical area, such as the heart, but a team of researchers led by Usman Baber, MD, Assistant Professor of Medicine at Mount Sinai School of Medicine, sought to demonstrate that atherosclerosis is a problem that affects many areas of the body. They investigated the prevalence of atherosclerosis in the carotid and coronary arteries using 3D ultrasound and computed tomography (CT) in 5,823 patients.

Overall, atherosclerosis was detected in 87. 8 percent of participants, but 3,341 participants had atherosclerosis in both their coronary and carotid arteries. Systemic atherosclerosis was more prevalent in men, individuals with diabetes, hypertension or who were of advanced age or Caucasian, and smokers.

“The High-Risk Plaque Initiative provided two critical findings. Firstly, that atherosclerosis is in most cases not limited to one area, but is a systemic problem,” said Dr. Baber. “Secondly, the HRP Initiative provides new evidence that 3D ultrasound coupled with CT is an important tool in detecting systemic vascular disease.”

The Mount Sinai Medical Center is among the world's leading centers for cardiovascular medicine, ranking in the “Top 10” in Cardiology & 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.

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 US News and 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 2011, US News and 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 US News and World Report and whose hospital is on the US News and 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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