The National Institutes of Health National Heart Lung and Blood Institute has awarded Weill Cornell Medicine investigators $4.2 million to compare quality of life outcomes in patients undergoing two different types of coronary artery bypass graft (CABG) surgery. CABG is commonly used to treat coronary artery disease, a condition in which plaque builds up in the arteries and blocks blood flow to the heart.
“We need to know whether patients who have undergone different CABG procedures not only live longer, with or without adverse events, but also what their quality of life is like,” said co-principal investigator Dr. Mario Gaudino, professor of cardiothoracic surgery at Weill Cornell Medicine and a cardiothoracic surgeon at NewYork-Presbyterian/Weill Cornell Medical Center. Whether patients feel stronger and experience less depression and fatigue after a procedure are important factors to consider, he said.
“Evaluating quality of life will help people with coronary artery disease, their caregivers and health providers make better and informed decisions about CABG,” said the study’s co-principal investigator, Dr. Ruth Masterson Creber, assistant professor of population health sciences at Weill Cornell Medicine. Coronary artery disease affects more than 18.2 million people in the United States.
The study is an ancillary study to an ongoing international, multicenter trial called Randomized comparison of the clinical Outcome of single versus Multiple Arterial grafts (ROMA). The ROMA trial is evaluating 4,300 CABG patients undergoing either a single arterial graft (SAG) or a multiple arterial graft (MAG) procedure. SAG involves taking an artery from the chest area, along with veins from the leg for grafting, while MAG uses arteries from the chest and/or forearm and mostly avoids veins. Researchers are assessing clinical outcomes such as death from any cause and postoperative complications, including stroke, heart attack and infection.
The ROMA trial is supported by a separate $4.1 million grant from the Canadian Institutes of Health Research and led by co-principal investigators Dr. Gaudino and Dr. Stephen Fremes at the University of Toronto.
Dr. Gaudino and his colleagues will probe the differences in SAG and MAG procedures on end points such as surgical complications, the need for repeat procedures and life expectancy. Prior research suggests that MAG bypass surgery may last longer than SAG because arteries may stay open longer than veins. While persistence of open arteries could be beneficial to the patient, it remains an intuitive association, said Dr. Gaudino.
In addition to assessing clinical outcomes of SAG versus MAG, clinicians also need to know how these surgeries are going to affect quality of life and patient’s symptom experience, said Dr. Masterson Creber, who is working with clinician-investigator Dr. Monika Safford, chief of the Division of Internal Medicine at Weill Cornell Medicine and NewYork-Presbyterian/Weill Cornell Medical Center, and Dr. Karla Ballman, chief of the Division of Biostatistics in the Department of Population Health Sciences at Weill Cornell Medicine, to investigate these patient-reported outcomes.
People may decide to undergo CABG surgery for a variety of reasons, said Dr. Masterson Creber. Many have chest pain, fatigue and problems with physical function. “Some people simply don’t feel quite right and go into surgery wanting to get back to normal daily living,” she said.
The ancillary study will assess more than 2,000 ROMA trial patients. Dr. Masterson Creber is also conducting a subgroup analyses of women undergoing CABG surgery. “Historically, there’s been a huge disparity in terms of women getting access to these procedures,” she said. “We want to evaluate the differences in women's symptom experience both before and after SAG and MAG surgeries, and their quality of life.”
She also wants to understand quality of life in patients with diabetes because the postoperative wound healing process can be complicated.
Until researchers have detailed information about the quality of life associated with the two CABG surgeries in various patient groups, “we won’t have the whole story on which procedure is better,” Dr. Gaudino said.