Safety and clinical performance of a drug eluting absorbable metal scaffold in the treatment of subjects with de novo lesions in native coronary arteries: Pooled 12-month outcomes of BIOSOLVE-II and BIOSOLVE-III
Catheter. cardiovasc. interv
; 92(7): 502, : 511, Dec. 2018. graf, tab, ilus
Article
em En
| SES-SP, CONASS, SESSP-IDPCPROD, SES-SP
| ID: biblio-1247595
Biblioteca responsável:
BR79.1
ABSTRACT
OBJECTIVES:
Based on outcomes of the BIOSOLVE-II study, a novel second generation drug eluting absorbable metal scaffold gained CE-mark in 2016. The BIOSOLVE-III study aimed to confirm these outcomes and to obtain additional 12-month angiographic data.BACKGROUND:
Bioresorbable scaffolds are intended to overcome possible long-term effects of permanent stents such as chronic vessel wall inflammation, stent crushing, and fractures.METHODS:
The prospective, multicenter BIOSOLVE-II and BIOSOLVE-III studies enrolled 184 patients with 189 lesions (123 patients in BIOSOLVE-II and 61 patients in BIOSOLVE-III). Primary endpoints were in-segment late lumen loss at 6 months (BIOSOLVE-II) and procedural success (BIOSOLVE-III).RESULTS:
Mean patient age was 65.5 6 10.8 years and mean lesion reference diameter was 2.70 6 0.43 mm. In BIOSOLVE-III, there were significantly more type B2/C lesions than in BIOSOLVE-II (80.3% versus 43.4%, P < 0.0001) and significantly more moderate-to-severe calcifications (24.2% versus 10.7%, P 5 0.014). At 12 months, there was no difference in late lumen loss between the two studies; in the overall population, it was 0.25 6 0.31 mm in-segment and 0.396 0.34 mm in scaffold. Target lesion failure occurred in six patients (3.3%) and included two cardiac deaths, one target-vessel myocardial infarction, and three clinically driven target lesion revascularizations. No definite or probable scaffold thrombosis was observed.CONCLUSION:
The pooled outcomes of BIOSOLVE-II and BIOSOLVE-III provide further evidence on the safety and performance of a novel drug-eluting absorbable metal scaffold with constant clinical and angiographic performance parameters at 12 months and no definite or probable scaffold thrombosis.
Texto completo:
1
Coleções:
06-national
/
BR
Contexto em Saúde:
6_ODS3_enfermedades_notrasmisibles
Base de dados:
CONASS
/
SES-SP
/
SESSP-IDPCPROD
Assunto principal:
Doença da Artéria Coronariana
/
Intervenção Coronária Percutânea
Tipo de estudo:
Clinical_trials
Limite:
Female
/
Humans
/
Male
Idioma:
En
Revista:
Catheter. cardiovasc. interv
Ano de publicação:
2018
Tipo de documento:
Article