Valentin Fuster, MD, PhD
A long-term international study led by researchers at Mount Sinai Heart is helping to establish an optimal standard of care for patients with diabetes and advanced multivessel coronary artery disease—a group at high risk for heart attack and stroke.
The FREEDOM Follow-On Study found that patients in this group who are treated with coronary artery bypass grafting (CABG) survive significantly longer than those treated with percutaneous coronary intervention (PCI) with drug-eluting stents.
Over a period of seven and one-half years, mortality from all causes was 18.7 percent for the CABG group and 23.7 percent for the PCI cohort. The study found that younger patients fared the best, with the difference most significant for those under age 63. “These data support current recommendations that CABG be considered the preferred strategy for patients with diabetes and multivessel disease,” says the study’s principal investigator, Valentin Fuster, MD, PhD, Director of Mount Sinai Heart, and Physician-in-Chief of The Mount Sinai Hospital.
During CABG, a healthy artery or vein from the body is connected, or grafted, to the blocked coronary artery, providing a bypass around the blocked portion of the coronary artery. In PCI—a minimally invasive procedure also known as angioplasty—a catheter is threaded through the body to a blocked or occluded vessel in the heart. The occlusion is removed and a drug-eluting stent is often inserted to maintain flow within the blood vessel.
The FREEDOM Follow-On Study, published in the Journal of the American College of Cardiology in November 2018, is the successor to the FREEDOM (Future Revascularization Evaluation in Patients with Diabetes Mellitus: Optimal Management of Multivessel Disease) trial, which randomized 1,900 patients with diabetes. That original study, which concluded in 2012, found that individuals who have diabetes and advanced coronary artery disease live longer and are less likely to suffer a nonfatal heart attack when treated with CABG instead of PCI with drug-eluting stents. The median follow-up time of that trial—just under four years—was considered relatively short, however, because of the prolonged nature of atherosclerotic cardiovascular disease.
Consequently, Mount Sinai developed a longer-term follow-up study, and 25 of the original international centers agreed to participate, tracking data on the mortality of 943 patients from the original FREEDOM trial. Adults with diabetes are two to four times more likely to die from heart disease than those without it, according to the American Heart Association.
In addition to confirming a standard of care for such patients, the study’s results underscore the importance of aggressive medical treatment and prevention to keep them from reaching advanced stages of diabetes, hypertension, and high cholesterol—forestalling the need for either CABG or PCI, Dr. Fuster says.
“We have to pay attention to how we can prevent this late stage of disease by taking care of obesity,” he says. “About 70 percent of these patients were obese, and we can do a lot to prevent this.”