Researchers from the Icahn School of Medicine at Mount Sinai and Weill Cornell Medicine, both located in New York City, have secured $29.9 million in funding from the Patient-Centered Outcomes Research Institute (PCORI) to evaluate the effectiveness of percutaneous coronary intervention (PCI) and coronary artery bypass surgery (CABG) among women and other underrepresented patient populations.
Cardiologists, cardiothoracic surgeons and scientists from the two academic institutions will collaborate on two parallel studies known as RECHARGE: Women and RECHARGE: Minorities. Each study will include up to 600 participants from the United States and Canada who present with coronary artery disease. Each patient must be seen as a valid candidate for both PCI and CABG. The studies are scheduled to launch in October, and patients will be followed for at least three years.
“Clinical practice guidelines recommend choosing between PCI or CABG based on evidence,” co-principal investigator Mario Gaudino, MD, PhD, a cardiothoracic surgeon at NewYork-Presbyterian/Weill Cornell Medical Center, said in a prepared statement. “However, prior studies have enrolled mostly non-Hispanic white men, leaving other patients with little guidance for making an informed decision.”
Gregg W. Stone, MD, director of academic affairs for the Mount Sinai Health System and professor of medicine and population health science and policy at Icahn Mount Sinai, is the group’s other co-principal investigator.
“These findings could transform cardiac care for women, Black, and Hispanic patients,” Stone said in a separate statement. “If outcomes are better with CABG than PCI in one or both groups than the majority of such patients should undergo surgery. Conversely, if survival and quality of life are similar or better after PCI, this less-invasive approach would be warranted for most patients.”
Stone also emphasized that these trials will both keep a close eye on improvements in each patient’s quality of life.
“Quality of life encompasses all the risks and benefits of the different procedures, and overcomes limitations of restricting the primary outcomes to a few select adverse event types which may be difficult to define and of variable importance,” he said. “We are hopeful this new approach will become recognized as the preferred principal outcome for future revascularization trials.”
PCORI is a nonprofit organization originally established by Congress in 2010 to fund healthcare research throughout the United States.
Michael has more than 16 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.