Patients With Diabetes and Advanced Heart Disease Lived Longer After Bypass Surgery Than Those Treated With Angioplasty
Greatest benefit in patients under 65 in highly anticipated eight-year final survival report for FREEDOM study
Patients who have diabetes and multivessel coronary artery disease that is treated with coronary-artery bypass grafting (CABG) survived about three years longer than similar patients who were treated with percutaneous coronary intervention with drug-eluting stents (PCI), researchers from the Icahn School of Medicine at Mount Sinai have found.
The mortality rate from all causes was significantly higher in the PCI group (24.31 percent) compared with the CABG group (18.3 percent) among 943 patients who were followed for eight years. More patients under 65 from the CABG group remained alive after eight years. This is the first study to demonstrate the long-term mortality benefit of CABG compared with PCI, a minimally invasive procedure commonly known as angioplasty, and to show that the greatest benefit is in patients under 65 years old.
Results of the FREEDOM Follow-on Study were presented as a late breaker at the American Heart Association Annual Scientific Sessions on Sunday, November 11, in Chicago and published simultaneously in the Journal of the American College of Cardiology.
The FREEDOM Follow-on Study is the final long-term follow-up report of the landmark FREEDOM (Future Revascularization Evaluation in Patients with Diabetes Mellitus: Optimal Management of Multivessel Disease) trial. After completion of the original FREEDOM trial in 2012, 25 international centers participated in the follow-on study.
Heart disease is the leading cause of morbidity and mortality in individuals with Type 2 diabetes.
“Treating people with diabetes and heart disease presents unique challenges due to increased risk for death, heart attack, and stroke,” said the study’s principal investigator, Valentin Fuster, MD, PhD, Director, Mount Sinai Heart, and Physician-in-Chief of The Mount Sinai Hospital. “The FREEDOM trial and Follow-on Study firmly establishes a standard of care for this high-risk population.”
Although further advances in PCI have been made since the original FREEDOM trial, the data support CABG over PCI in patients with stable coronary artery disease and diabetes.
“These findings provide clear evidence that CABG plus standard medical therapy is the optimal treatment path for patients with diabetes and extensive coronary disease,” said Michael Farkouh, MD, the Peter Munk Chair in Multinational Clinical Trials at the University of Toronto, adjunct scientist at the Icahn School of Medicine at Mount Sinai, and the co-principal investigator of the FREEDOM trial and FREEDOM Follow-on Study.
Other Mount Sinai researchers who participated in the study included George Dangas, MD, PhD, Professor of Medicine (Cardiology) and Surgery at the Icahn School of Medicine and Director of Cardiovascular Innovation at the Zena and Michael A. Wiener Cardiovascular Institute, and Samin Sharma, MD, Director of Clinical and Interventional Cardiology, The Mount Sinai Hospital.
Other institutions involved in this research include the University of Toronto.
About the Mount Sinai Health System
The Mount Sinai Health System is New York City's largest integrated delivery system, encompassing eight hospitals, a leading medical school, and a vast network of ambulatory practices throughout the greater New York region. Mount Sinai's vision is to produce the safest care, the highest quality, the highest satisfaction, the best access and the best value of any health system in the nation. The Health System includes approximately 7,480 primary and specialty care physicians; 11 joint-venture ambulatory surgery centers; more than 410 ambulatory practices throughout the five boroughs of New York City, Westchester, Long Island, and Florida; and 31 affiliated community health centers. The Icahn School of Medicine is one of three medical schools that have earned distinction by multiple indicators: ranked in the top 20 by U.S. News & World Report's "Best Medical Schools", aligned with a U.S. News & World Report's "Honor Roll" Hospital, No. 12 in the nation for National Institutes of Health funding, and among the top 10 most innovative research institutions as ranked by the journal Nature in its Nature Innovation Index. This reflects a special level of excellence in education, clinical practice, and research. The Mount Sinai Hospital is ranked No. 14 on U.S. News & World Report's "Honor Roll" of top U.S. hospitals; it is one of the nation's top 20 hospitals in Cardiology/Heart Surgery, Diabetes/Endocrinology, Gastroenterology/GI Surgery, Geriatrics, Gynecology, Nephrology, Neurology/Neurosurgery, and Orthopedics in the 2019-2020 "Best Hospitals" issue. Mount Sinai's Kravis Children's Hospital also is ranked nationally in five out of ten pediatric specialties by U.S. News & World Report. The New York Eye and Ear Infirmary of Mount Sinai is ranked 12th nationally for Ophthalmology and Mount Sinai South Nassau is ranked 35th nationally for Urology. Mount Sinai Beth Israel, Mount Sinai St. Luke's, Mount Sinai West, and Mount Sinai South Nassau are ranked regionally.