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Improving External Validity of the RECHARGE Trial through a Partially Randomized Patient Preference Framework

Award Number: R01HL184552
ORGANIZATION: NATIONAL HEART, LUNG, & BLOOD INSTITUTE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/01/2026
PERIOD OF PERFORMANCE END DATE: 05/31/2031

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Improving External Validity of the RECHARGE Trial through a Partially Randomized Patient Preference Framework - PROJECT SUMMARY Coronary artery disease (CAD) remains the leading cause of death for Americans of all sexes, races, and ethnicities, yet randomized controlled trials (RCTs) informing practice guidelines have predominantly enrolled white men. Observational data suggest that outcomes after coronary artery bypass grafting (CABG) and percutaneous coronary intervention (PCI) vary by sex and race. To address this, the RECHARGE (REvascularization CHoices Among under-Represented Groups Evaluation) program was developed. It includes two integrated, multicenter, open-label, 1:1 randomized superiority trials—RECHARGE:Women (NCT06399692) and RECHARGE:Minorities (NCT06399705)—funded by the US Patient-Centered Outcomes Research Institute (PCORI). The trials will enroll 1,200 patients in up to 100 sites to compare PCI vs. CABG in women and Black or Hispanic patients with multivessel CAD referred for revascularization. The primary endpoint is a hierarchical composite of death and time-averaged change in generic quality of life. RECHARGE has broad inclusion criteria to maximize external validity, but strong patient preferences for CABG or PCI may lead to randomization refusal, limiting generalizability. In RECHARGE's feasibility phase, 80% of eligible patients decline participation due to treatment preferences. By enrolling these patients in a parallel preference cohort within a unified Partially Randomized Patient Preference (PRPP) analytic framework, we can enhance external validity. PRPP trials have never been used in coronary revascularization, where patient preferences strongly influence decision-making. With RECHARGE entering its full phase in November 2025, we have a time-sensitive opportunity to integrate a PRPP framework to (i) improve generalizability and (ii) evaluate the feasibility of incorporating preference cohorts in cardiovascular RCTs. We will enroll 1,000 women and 1,000 Black or Hispanic patients who decline randomization in RECHARGE into a parallel observational cohort. We will collect detailed baseline characteristics, document reasons for declining randomization, and track outcomes in parallel with the randomized cohort. In Aim I, we will determine social, biological, and institutional predictors of unwillingness to be randomized to CABG vs. PCI, to understand which women and Black and Hispanic patients the RCT findings are directly applicable to. In aim II we will first pool patients from the RCTs and observational cohorts to develop prediction models for the strength of preference for CABG versus PCI, and then use these models to extrapolate the treatment effects observed in the randomized cohort to the full cohort of eligible patients. In aim III we will analyze outcomes data for RECHARGE:PRPP cohort to improve precision in the estimated average treatment effect from the RCT and explore treatment effect heterogeneity across patient characteristics. By integrating the patients who declined randomization in the RCTs in a PRPP framework alongside the RCT cohorts, RECHARGE:PRPP will provide a more representative evaluation of CABG vs. PCI, setting a precedent for future cardiovascular RCTs.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2026 ( Subtotal = $863,551 )
2026	2026	WEILL MEDICAL COLLEGE OF CORNELL UNIVERSITY	575 LEXINGTON AVE FL 9	NEW YORK	NY	10022	NEW YORK	USA	Cardiovascular Diseases Research	000	1	9/1/2026	NEW	$863,551
														Subtotal = $863,551

Grand Total All Awards = $863,551

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Improving External Validity of the RECHARGE Trial through a Partially Randomized Patient Preference Framework

Award Number: R01HL184552

ORGANIZATION: NATIONAL HEART, LUNG, & BLOOD INSTITUTE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 09/01/2026

PERIOD OF PERFORMANCE END DATE: 05/31/2031

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