Adults with diabetes and multi-vessel coronary heart disease who underwent cardiac bypass surgery had better overall heart-related outcomes than those who underwent a percutaneous coronary intervention, according to a study.
The study compared the effectiveness of coronary artery bypass graft surgery with PCI that included insertion of drug-eluting stents. After five years, the CABG group had fewer adverse events and better survival rates than the PCI group.
“These study results confirm that bypass surgery is a better overall treatment option for individuals with diabetes and multi-vessel coronary disease and may assist physicians efforts to prevent cardiovascular events in this high-risk group,” Gary H. Gibbons, MD, director of the National Heart, Lung and Blood Institute, which funded the study, said in a news release.
In the United States, more than 1 million procedures are performed each year to restore circulation to patients with blocked arteries. Approximately 25% to 30% of patients needing CABG or PCI have diabetes and multi-vessel coronary heart disease.
The study involved 140 international centers and a total of 1,900 adults enrolled from 2005 to 2010. The participants had diabetes and coronary heart disease that involved narrowing of multiple blood vessels, but not the left main coronary artery, which usually requires immediate treatment with CABG.
At each clinical site, a team of specialists in neurology, heart disease, diabetes and general medicine screened potential participants to ensure that they were eligible for both CABG and PCI. Those who were selected for the trial were randomly assigned to receive one of the interventions. As recommended by international guidelines for patients who receive drug-eluting stents, the PCI group also received anti-clotting therapies. The drug abciximab was administered intravenously during the procedure, and clopidogrel was given orally for at least 12 months after the procedure, accompanied by aspirin for those who could tolerate it. Study participants were followed for at least two years.
During the trial, participants received standard medical care for all major cardiovascular risk factors such as high LDL cholesterol, hypertension and hyperglycemia. Participants also were counseled about lifestyle choices such as smoking cessation, diet and regular exercise.
After five years, the CABG group had a lower combined rate of strokes myocardial infarction and deaths (18.7%) than the PCI group (26.6%). Stroke, a well-known risk of bypass surgery, occurred slightly more often in the CABG group (5.2%) than in the PCI group (2.4%). However, more people died from any cause in the PCI group (16.3%) than in the CABG group (10.9%). The survival advantage of CABG over PCI was consistent regardless of race, gender, number of blocked vessels or disease severity.
“The advantages of CABG over PCI were striking in this trial and could change treatment recommendations for thousands of individuals with diabetes and heart disease,” said Valentin Fuster, MD, PhD, the studys principal investigator out of Mount Sinai School of Medicine in New York City.
The study was presented Nov. 4 in Los Angeles at the American Heart Associations annual meeting and also appears on the website of the New England Journal of Medicine: www.nejm.org/doi/full/10.1056/NEJMoa1211585?query=featured_home.