The lack of diversity in cardiac surgery trials may be harmful to patients
A prominent leader in cardiac surgery is calling for more clinical trials to focus on best practices when treating women and minorities. Because many surgical trials have centered on white men, he explained, this has not always been the case. He is also challenging the way success in surgical trials is measured.
"The inconvenient truth is that the majority of clinical research that we have done in the last 20 years only apply to middle-aged white men, this patient population that has been largely overrepresented in all previous cardiovascular therapies. The fact that in clinical practice we are using data derived from studies that enrolled 90% white men to make treatment decisions in women or in non-white patients, I think, is a major issue," explained Mario Gaudino, MD, PhD, director of translational and clinical research in the department of cardiothoracic surgery and the Stephen and Suzanne Weiss Professor in Cardiothoracic Surgery with Weill Cornell Medicine at NewYork-Presbyterian Hospital.
He has spoken on this longstanding issue in cardiovascular research at the 2024 American Heart Association (AHA) Scientific Sessions and other cardiology meetings.
"We are trying to finally to provide research data that really informative and important for the totality of the patient that we treat and not only a small subgroup of them," he explained.
The RECHARGE and ROMA trials centering on underrepresented populations
To address this gap, Gaudino is leading several landmark studies aimed at correcting the imbalance. Among them are the ROMA WOMEN and RECHARGE trials—new efforts designed to generate clinical data that are truly representative.
ROMA WOMEN is the first cardiac surgery trial dedicated exclusively to women. It focuses on comparing arterial versus venous grafts in coronary artery bypass grafting (CABG), a procedure performed on more than 400,000 Americans annually. Historically, trials in this space have failed to enroll enough women to draw meaningful conclusions for female patients, he said.
"Women present with coronary artery disease later in life in women as compared to men. And then also there is a delay in diagnosis. So as a result, the women referred for bypass surgery are much older compared to men. And in the United States, 40% of the women undergoing bypass surgery are older than 70," Gaudino explained.
He said some previous trials also set a younger cut off age. So for ROMA WOMEN, it only includes women and it was a minimum cutoff age at 70. He said the large percentage of younger men in previous trials skewed the data and the result was that these trials are not really applicable to older women.
Remarkably, the ROMA WOMEN trial is ahead of schedule in enrollment, a very uncommon feat in clinical research. Results from the large 4,000-patient randomized trial are expected in 2027.
The RECHARGE trial, meanwhile, features two complementary trials—RECHARGE WOMEN and RECHARGE MINORITY—which compare outcomes of percutaneous coronary intervention (PCI) versus CABG surgery. RECHARGE MINORITY specifically focuses on Black and Hispanic patients, who, like women, have often been excluded or underrepresented in prior studies.
"We don't have high-quality information on those patient subgroups," Gaudino explained. "This is an issue. It's actually potentially harming our patients."
Redefining cardiac surgery trial outcomes with patient voices
Beyond representation, Gaudino is also challenging how success is defined in clinical trials. He described how patient engagement has reshaped the endpoints used in the RECHARGE trials.
“When we asked patients what mattered most, they didn’t talk about traditional clinical endpoints like perioperative myocardial infarction. They talked about quality of life, going dancing, fishing with their buddies, and that they just was to feel good,” he said.
This feedback led the RECHARGE team to develop a novel composite outcome based on overall well-being and longevity—shifting from traditional, clinician-defined endpoints to outcomes that resonate with patients themselves.
He said it was an unusual experience working with patients to create a new way to track how they feel following different treatments.
"It's a new composite outcome that has not been used before, and it's also, quite frankly, more complex to use. The statistics behind it are much more complicated. That was largely outside of our comfort zone, but we decided that this was the right thing to do," Gaudino said.
Greater inclusion and patient-centered design in cardiac surgery research are not just ethical imperatives, he said; they are scientific necessities.
"I think as a trialist, it's time that we stop designing trials for the trialist and for physicians and we start designing trial for patients, because ultimately this is what we are supposed to be doing," Gaudino stressed.
Dave Fornell has covered healthcare for more than 17 years, with a focus in cardiology and radiology. Fornell is a 5-time winner of a Jesse H. Neal Award, the most prestigious editorial honors in the field of specialized journalism. The wins included best technical content, best use of social media and best COVID-19 coverage. Fornell was also a three-time Neal finalist for best range of work by a single author. He produces more than 100 editorial videos each year, most of them interviews with key opinion leaders in medicine. He also writes technical articles, covers key trends, conducts video hospital site visits, and is very involved with social media. E-mail: [email protected]