Patient-Centered Outcomes Research Institute Award Will Fund RECHARGE Trials of PCI Versus CABG in Women and Minority Groups

July 25, 2023—The Icahn School of Medicine at Mount Sinai in New York, New York, announced that it will help lead and launch a clinical trial focusing on women and minority populations to determine which coronary revascularization procedure best improves their survival and quality of life.

The trial will be funded with $29.9 million from the Patient-Centered Outcomes Research Institute awarded to the Icahn School of Medicine and Weill Cornell Medicine, also in New York, which will share the funding.

Gregg W. Stone, MD, and Maurio Gaudino, MD, will serve as Principal Investigators. Dr. Stone is Director of Academic Affairs for the Mount Sinai Health System and Professor of Medicine (Cardiology) and Population Health Science and Policy at Icahn Mount Sinai. Dr. Gaudino is the Stephen and Suzanne Weiss Professor in Cardiothoracic Surgery and Assistant Dean for Clinical Trials at Weill Cornell Medicine.

According to the Icahn press release, the award will be distributed in several phases to conduct two integrated RECHARGE trials called RECHARGE:Women and RECHARGE:Minorities. The trials are set to launch in October 2023.

The trials will enroll approximately 1,200 patients who are eligible for treatment with either percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG) at 45 or more sites in the United States and Canada. The overall study will be conducted during a 6.5-year period.

“While there have been many trials comparing CABG surgery and PCI, most have enrolled predominantly White men,” stated Dr. Stone in the Icahn press release. “There is thus a great need to generate high-quality evidence to guide clinical decision-making for such procedures in women and minority groups who have been underrepresented in most prior studies.”

Dr. Stone continued, “We have designed these trials to examine a specific primary endpoint that is central to what patients want: to live longer and feel better. Our primary composite hierarchical endpoint is thus survival and improvement in quality of life, integrated over 3-year follow-up.”

He added, “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. We are hopeful this new approach will become recognized as the preferred principal outcome for future revascularization trials.”

Finally, Dr. Stone noted, “These findings could transform cardiac care for women and Black and Hispanic patients. If outcomes are better with CABG than PCI in one or both groups, then 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.”

The Patient-Centered Outcomes Research Institute is an independent, nonprofit organization authorized by the United States Congress in 2010. The institute’s mission is to fund research that will provide patients, their caregivers, and clinicians with the evidence-based information needed to make better-informed health care decisions.

This funding award has been approved pending completion of a business and programmatic review by the institute’s staff and issuance of a formal award contract, advised Icahn School of Medicine.