A randomized controlled trial comparing BioMime Sirolimus-Eluting Stent with Everolimus-Eluting Stent: two-year outcomes of the meriT-V trial
Cardiol Res.
; 14(4): 291-301, ago.2023. ilus
Article
en En
| CONASS, SES-SP, SESSP-IDPCPROD, SES-SP
| ID: biblio-1525284
Biblioteca responsable:
BR79.1
ABSTRACT
BACKGROUND:
Drug-eluting stents (DESs) based on biodegradable polymers (BPs) have been introduced to reduce the risk for late and very late stent thrombosis (ST), which were frequently observed with earlier generations of DES designs based on durable polymers (DPs); however, randomized controlled trials on these DES designs are scarce. The meriT-V trial is a randomized, active-controlled, non-inferiority trial with a prospective, multicenter design that evaluated the 2-year efficacy of a novel third-generation, ultra-thin strut, BP-based BioMime sirolimus-eluting stent (SES) versus the DP-based XIENCE everolimus-eluting stent (EES) for the treatment of de novo lesions.METHODS:
The meriT-V is a randomized trial that enrolled 256 patients at 15 centers across Europe and Brazil. Here, we report the outcomes of the extended follow-up period of 2 years. The randomization of enrolled patients was in a 21 ratio; the enrolled patients received either the BioMime SES (n = 170) or the XIENCE EES (n = 86). The three-point major adverse cardiac event (MACE), defined as a composite of cardiac death, myocardial infarction (MI), or ischemia-driven target vessel revascularization (ID-TVR), was considered as the composite safety and efficacy endpoint. Ischemia-driven target lesion revascularization (ID-TLR) was evaluated as well as the frequency of definite/probable ST, based on the first Academic Research Consortium definitions.RESULTS:
The trial had a 2-year follow-up completion rate of 98.44% (n = 252/256 patients), and the clinical outcomes assessment showed a nonsignificant difference in the cumulative rate of three-point MACE between both arms (BioMime vs. XIENCE 7.74% vs. 9.52%, P = 0.62). Even the MI incidences in the BioMime arm were insignificantly lower than those of the XIENCE arm (1.79% vs.
Texto completo:
1
Colección:
06-national
/
BR
Base de datos:
CONASS
/
SES-SP
/
SESSP-IDPCPROD
Asunto principal:
Enfermedad de la Arteria Coronaria
/
Stents Liberadores de Fármacos
/
Intervención Coronaria Percutánea
Tipo de estudio:
Clinical_trials
Idioma:
En
Revista:
Cardiol Res.
Año:
2023
Tipo del documento:
Article