Expanding revascularization trials to women and underserved minorities and shifting to patient-centered outcomes: RECHARGE trials program.
Curr Opin Cardiol
; 39(6): 478-484, 2024 Nov 01.
Article
en En
| MEDLINE
| ID: mdl-39254647
ABSTRACT
PURPOSE OF REVIEW We review the limited available evidence informing coronary revascularization decisions in women and minorities, and introduce the RECHARGE trial program, which consists of two separate but integrated parallel multicenter, randomized trials comparing coronary artery bypass grafting (CABG) to percutaneous coronary intervention (PCI), one exclusively enrolling women (RECHARGEWomen) and one exclusively enrolling Black or Hispanic patients (RECHARGEMinorities). RECENT FINDINGS:
The extensive evidence base supporting coronary revascularization suffers from under-representation of women, minorities and minoritized populations, and the use of heterogeneous primary composite outcomes whose components have varying strengths of association with prognosis and quality-of-life (QOL). In RECHARGE, participants will be followed for up to 10âyears, with QOL assessments at baseline, 30âdays, 3âmonths, every 6 months for 3âyears, and annually thereafter. The primary endpoint is the hierarchical composite of time to all-cause mortality, time-averaged change from baseline in the physical component of the SF-12v2 physical summary score, and time-averaged change from baseline in the mental component of the SF12v2 summary score, evaluated using a win ratio. Independently adjudicated major adverse cardiovascular and noncardiovascular events and disease-specific QoL will be secondary endpoints.SUMMARY:
The RECHARGE trials are the first revascularization trials to enroll exclusively women and minority patients and to use patient-centered outcomes as their primary outcome.
Texto completo:
1
Colección:
01-internacional
Base de datos:
MEDLINE
Asunto principal:
Intervención Coronaria Percutánea
Límite:
Female
/
Humans
Idioma:
En
Revista:
Curr Opin Cardiol
Asunto de la revista:
CARDIOLOGIA
Año:
2024
Tipo del documento:
Article
Pais de publicación:
Estados Unidos