September 12, 2023
Valley Health System is pleased to participate in the ROMA: WOMEN clinical trial, the first cardiovascular surgery clinical trial in women. Valley recently enrolled its first two patients in the trial. Sponsored by Weill Medical College of Cornell University and The Starr Foundation, the trial is designed to determine which bypass graft type is more effective for women with coronary artery disease (CAD) who are undergoing coronary artery bypass grafting (CABG) procedure.
Coronary artery disease is a narrowing or blockage of the arteries that deliver blood and oxygen to the heart muscle. CAD is the most common type of heart disease, which is the leading cause of death among women, according to the Centers for Disease Control and Prevention. Coronary Artery Bypass Grafting (CABG) provides a very effective treatment with significant survival advantages over any other form of treatment of multivessel coronary artery disease. During the procedure, a cardiac surgeon will reroute blood flow by bypassing blocked arteries using bypass grafts, or healthy blood vessels harvested from the chest, arms, or legs.
The ROMA: WOMEN study will help researchers determine whether the use of multiple arterial grafts (MAG) – the use of two or more arterial grafts - is safer and more effective than single arterial grafts (SAG) – the use of one arterial graft – for women who are undergoing a CABG procedure. The more than 2,000 patients who are expected to be enrolled will be followed by the sponsor’s research team for up to 12 years from the time of inclusion in the trial.
Women are historically under-represented in clinical trials, and research has shown that they are less likely to receive optimal treatment for their CAD, according to “Sex Differences in Coronary Artery Bypass Grafting Techniques: A Society of Thoracic Surgeons Database Analysis,” by Jawitz and colleagues, and published in PubMed in July 2021.
Also, women are more likely to have poorer outcomes than men with the same condition, per “Operative Outcomes of Women Undergoing Coronary Artery Bypass Surgery in the US, 2011 to 2020,” by Gaudino and colleagues, and published in the Journal of the American Medical Association Surgery in March 2023.
The ROMA: WOMEN study provides an opportunity to focus exclusively on enrolling women patients and supporting an improved understanding about what surgical strategies are best for these patients.
“I am thrilled to report Valley’s involvement in this revolutionary cardiac surgery clinical trial. Traditionally, women have been underrepresented in clinical trials. The ROMA Trial challenges this stereotype, calling for more research relating to women’s cardiovascular health, specifically as it relates to guideline-directed surgical care,” said Juan B. Grau, MD, Director of Cardiothoracic Surgery for The Valley Hospital, and Principal Investigator at Valley Health System.
“Valley’s participation in the ROMA Trial aligns with the organization’s vision to foster diversity, equity, and inclusion (DEI) in research and clinical trials for underrepresented patient populations, including racial and ethnic minority groups,” said Julia Karcher, Senior Vice President of Valley Health System and Valley Medical Group. “I am proud of Valley’s participation and the steps taken to implement a change within the cardiac surgery research space.”
To participate, women must be 18 years old or older and have a diagnosis of significant disease of the left main coronary artery or disease involving two or more coronary artery branches with a recommendation for an isolated coronary artery bypass grafting procedure as a treatment. Additionally, the patient may not have had prior cardiac surgery.
Learn more about this clinical trial and the eligibility criteria by visiting ValleyHealth.com/ROMAWomen. For more information about the trial or to see if you are eligible, please call 201-634-5792.
To learn more about coronary artery bypass surgery at Valley, please visit ValleyHealth.com/CABG.