Lessons learned from the feasibility phase of the REvascularization CHoices Among Under-Represented Groups Evaluation
Mario Gaudino1, Gregg W Stone2, John Puskas3
1Department of Cardiothoracic Surgery, Weill Cornell Medicine, New York, NY.
Background:
The REvascularization CHoices Among Under-Represented Groups Evaluation (RECHARGE) program is enrolling 1200 women, Black and Hispanic patients, in 2 parallel randomized trials of percutaneous coronary intervention vs coronary artery bypass grafting.
Methods:
Funded by a phased Patient-Centered Outcomes Research Institute award, the pilot phase was designed to assess the feasibility of enrolling groups historically under-represented and challenging to enroll in prior revascularization trials, evaluate willingness of patients to accept randomization, refine patient and stakeholder engagement, and scale site infrastructure and data collection across diverse centers. We report key insights from the pilot phase.
Results:
Physician and patient treatment preferences, often shaped by prior experience and evidence not directly applicable to these cohorts, were the main reasons eligible patients were not randomized. Many sites also lacked consistent multidisciplinary Heart Team processes for coronary disease, requiring new workflows to establish equipoise between percutaneous coronary intervention and coronary artery bypass grafting. Successful recruitment required intentional trust-building and tailored patient-facing materials, while engagement of non-academic centers demanded added financial, educational, and start-up support. During the 2-year pilot phase, 91 US and 17 Canadian sites were selected, and 65 were activated. Median activation time was 10.8 months (Interquartile range [IQR] 9.1-13.6). The pilot enrollment goal of 60 participants was exceeded, with 141 patients randomized within 13 months at a mean rate of 0.27 patients/site/month, prompting expansion to up to 150 sites for the full program.
Conclusion:
The lessons learned from the pilot phase of the REvascularization CHoices Among Under-Represented Groups Evaluation program can inform the design and implementation of future randomized trials seeking to enroll traditionally under-represented populations.
Trial Registration:
REvascularization CHoices Among Under-Represented Groups Evaluation: The RECHARGE Trial; NCT06399705 (RECHARGE:M) and NCT06399692 (RECHARGE:W).
