Trial Is Comparing Effectiveness of CABG and PCI in Underrepresented Groups and Women

Mount Sinai has launched the country’s first clinical trial to determine which coronary revascularization process—coronary artery bypass graft (CABG) or percutaneous coronary intervention (PCI)—is most effective in improving survival and quality of life of women and Black and Hispanic populations. The five-year, 1,200-patient study is funded by $29.9 million from the Patient-Centered Outcomes Research Institute, an independent organization authorized by Congress to support research that provides patients, caregivers, and clinicians with evidence-based information to make better-informed health care decisions.

“It’s time for our field to address this critical topic by focusing on women and underrepresented minorities after many years of enrolling predominantly white men in coronary revascularization studies,” says Icilma Fergus, MD, Professor of Medicine (Cardiology) at the Icahn School of Medicine at Mount Sinai and site principal investigator of the trial, which is actively enrolling patients. “We believe our findings could transform cardiac care for women and Black and Hispanic patients by enabling us to inform them which treatment will lead to the best outcomes and highest rate of survival for their group.”

The Revascularization Choices Among Underrepresented Groups Evaluation (RECHARGE) study is enrolling women and underrepresented minorities in two separate trials—RECHARGE: Women and RECHARGE: Minorities. The two parallel arms are recruiting 600 women and 600 Black or Hispanic patients at 45 sites with multivessel or left main coronary artery disease (CAD) that cannot be adequately managed with medication. The national principal investigators for the study are Gregg W. Stone, MD, Professor of Medicine (Cardiology), and Population Health Science and Policy at the Icahn School of Medicine at Mount Sinai; and Mario Gaudino, MD, PhD, Professor of Cardiothoracic Surgery, and Assistant Dean for Clinical Trials at Weill Cornell Medicine.

Participants must be female and/or Black or Hispanic and at least 18 years old, with multivessel or left main coronary artery disease for which revascularization is indicated by the local heart team, and for which there is equipoise between CABG and PCI. Following cardiac catheterization, patients are randomized one-to-one to either the CABG or the PCI cohort, but only if both procedures can achieve comparable clinical results, and true equipoise exists. The process recognizes that coronary artery disease may be too advanced for PCI in some patients, while others may be too frail to tolerate CABG. In these cases, equipoise does not exist, and patients would be excluded from the trial. Other exclusion criteria are cardiogenic shock, myocardial infarction, pregnancy, prior PCI within a year or any prior CABG, and life expectancy of less than three years. Survival status and clinical events will be assessed by telephone at 1, 3, 6, 12, 18, 24, 30, and 36 months post-randomization.

The study diverges from the many previous trials because its primary aim is to compare CABG to PCI. “Instead of restricting outcomes to a few adverse event types, which are difficult to define and have variable importance, our primary hierarchical endpoint is survival and improvement in quality of life, which will be assessed at three- and six-month intervals by the study team via telephone,” Dr. Fergus says. “We’re hopeful this more comprehensive approach will become the preferred principal outcome for future revascularization trials.”

For cardiologists, the study has the potential to provide invaluable evidence to inform and support treatment plans. “If we know that the patient would benefit equally from either procedure, then we wouldn’t be afraid to send someone with multiple comorbidities, for example, to PCI knowing they would have a good outcome,” Dr. Fergus says. “Without that insight, open-heart surgery might be the preferred intervention for people with diabetes or multiple issues.”

“The classic academic exercise of comparing revascularization modalities in an elusive search for a clear ‘winner’ has failed,” Dr. Stone and Dr. Gaudino said in a 2023 article in the Journal of the American College of Cardiology. “Both PCI and CABG are here to stay, and future comparative research should empower each patient (assisted by their physician) with the knowledge to choose the right procedure for them.”

Serving as site principal investigator of the RECHARGE trial is a fitting extension of Dr. Fergus’ ongoing and extensive work in community outreach and health equity, and as Director of Cardiovascular Disparities at Mount Sinai. “My job as director is to figure out what circumstances and issues are contributing to people not getting equitable health care, then try to ameliorate them,” she says. “In that role, I do a lot of education outreach and connecting to individuals so if they have any questions, doubts, or fears, we can try to allay them and make them feel comfortable in their health care engagement with Mount Sinai. And that includes their potential participation in clinical trials.”

This commitment makes Dr. Fergus a frequent visitor to underrepresented communities surrounding Mount Sinai’s main campus, such as Harlem, where cardiovascular morbidity and mortality are the highest in the New York City area. She has established programs such as the Healthy Heart Series and Harlem Healthy Heart, where she brings a team of cardiologists, nurse practitioners, nutritionists, and medical students to community centers and churches to conduct monthly workshops and screening opportunities aimed at promoting cardiometabolic health. Another focus of that education outreach is primary care providers, who are informed, among other things, of clinical trials and studies that could be helpful to their patients.

“Our goal is to not only provide access to quality care for these underserved individuals,” Dr. Fergus says, “but to help them develop trust in their providers so that they’re encouraged to seek them out before serious health issues develop.”

To learn more, call 212-746-1815 or go to the RECHARGE clinical trial site.