Comparison of clinical outcomes between Magmaris and Orsiro drug eluting stent at 12 months: Pooled patient level analysis from BIOSOLVE II-III and BIOFLOW II trials
Int. j. cardiol
; 300(1): 60-65, Jul, 2019. tabela, gráfico
Artículo
en Inglés
| Sec. Est. Saúde SP, SESSP-IDPCPROD, Sec. Est. Saúde SP
| ID: biblio-1103433
Biblioteca responsable:
BR79.1
Ubicación: BR79.1
ABSTRACT
Background The aim of this study was to compare the 12-month clinical outcomes of patients treated with Magmaris or Orsiro. Second generation drug-eluting absorbable metal scaffold Magmaris (Dreams 2G) has proved to be safe and effective in the BIOSOLVE-II study. Similarly, biodegradable polymer sirolimus-eluting stent, Orsiro has shown notable clinical results even in all-comer populations. Methods Magmaris group patients were taken from the BIOSOLVE-II and BIOSOLVE-III trials, while the patients from Orsiro group were enrolled in BIOFLOW-II trial. The primary outcome was explored using a time-to-event assessment of the unadjusted clinical outcomes for target lesion failure (TLF) at 12â¯months, followed by a multivariate analysis adjusting for all the significantly different covariates between the groups. Results The study population consisted of 482 patients (521 lesions), 184 patients (189 lesions) in Magmaris group and 298 patients (332 lesions) in Orsiro group. The mean age was 65.5⯱â¯10.8 and 62.7⯱â¯10.4â¯years in Magmaris and Orsiro groups, respectively ( pâ¯=â¯0.005). Magmaris and Orsiro unadjusted TLF rates were 6.0 and 6.4% with no significant difference between the groups ( pâ¯=â¯0.869). In the multivariate analysis, there were no meaningful differences between Magmaris and Orsiro groups. Finally, none of the groups presented device thrombosis cases at 12â¯months. Conclusion At 12â¯months there were no significant differences between Magmaris and Orsiro groups neither in the unadjusted assessment nor in the multivariate analysis for target lesion failure. These results should be taken as hypothesis generating and may warrant a head to head comparison on a randomized fashion.
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Colección:
Bases de datos nacionales
/
Brasil
Contexto en salud:
Agenda de Salud Sostenible para las Américas
Problema de salud:
Objetivo 5: Medicamentos, vacunas y tecnologías sanitarias
Base de datos:
Sec. Est. Saúde SP
/
SESSP-IDPCPROD
Asunto principal:
Análisis Multivariante
/
Stents Liberadores de Fármacos
Tipo de estudio:
Ensayo clínico controlado
Idioma:
Inglés
Revista:
Int. j. cardiol
Año:
2019
Tipo del documento:
Artículo
Institución/País de afiliación:
Aarhus University Hospital/DK
/
Bern University Hospital/CH
/
Division of Interventional Cardiology MedStar Cardiovascular Research Network/US
/
Erasmus Medical Center/hungria
/
Herzzentrum Segeberger Kliniken/DE
/
Institut Cardiovasculaire Paris Sud (ICPS)/FR
/
Instituto Dante Pazzanese de Cardiologia/BR
/
Interventional Cardiology Middelheim Hospital/BE
/
Lukas Krankenhaus Neuss/DE
/
Medisch Spectrum Twente, Thoraxcentrum Twente/hungria