Researchers will carry out the first clinical trial focusing on women and minority populations to determine which coronary revascularisation procedure best improves their survival and quality of life.
This trial will be funded through US$29.9 million from the Patient-Centered Outcomes Research Institute Award to the Icahn School of Medicine at Mount Sinai and Weill Cornell Medicine (both New York, USA).
“While there have been many trials comparing coronary artery bypass graft (CABG) surgery and percutaneous coronary intervention (PCI), most have enrolled predominantly white men. 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,” explained Gregg W Stone (Icahn Mount Sinai, New York, USA) who is one of the two principal investigators of this trial.
“We have designed these trials to examine a specific primary endpoint that is central to what patients want: to live longer and feel better,” Stone adds. “Our primary composite hierarchical endpoint is thus survival and improvement in quality of life, integrated over three-year follow-up. 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 recognised as the preferred principal outcome for future revascularisation trials.”
Icahn Mount Sinai and Weill Cornell Medicine will share the funding, and Maurio Gaudino (Weill Cornell Medicine, New York, USA) will serve as co-principal investigator with Stone. The award will be distributed in several phases to conduct the two integrated “REvascularization CHoices Among UnderRepresented Groups Evaluation (RECHARGE) trials called RECHARGE:Women and RECHARGE:Minorities. These are set to launch in October 2023.
They will enrol a total of approximately 1,200 patients across 45 or more sites in the USA and Canada who are eligible for treatment with either PCI or CABG. The overall study will be conducted over a 6.5-year period.
“These findings could transform cardiac care for women, Black, and Hispanic patients. 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 adds.
The Patient-Centered Outcomes Research Institute is an independent, non-profit organisation authorised by the US Congress in 2010. Its 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 Patient-Centered Outcomes Research Institute staff and issuance of a formal award contract.