Sustained safety and clinical performance of a drug-eluting absorbable metal scaffold up to 24 months: pooled outcomes of BIOSOLVE-II and BIOSOLVE-III
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Citações na Scopus
121
Tipo de produção
article
Data de publicação
2017
Editora
EUROPA EDITION
Indexadores
Título da Revista
ISSN da Revista
Título do Volume
Autores
HAUDE, Michael
INCE, Huseyin
KISCHE, Stephan
ABIZAID, Alexandre
TOLG, Ralph
MIEGHEM, Nicolas M. Van
VERHEYE, Stefan
BIRGELEN, Clemens von
CHRISTIANSEN, Evald Hoj
Autor de Grupo de pesquisa
BIOSOLVE-II BIOSOLVE-III Investig
Editores
Coordenadores
Organizadores
Citação
EUROINTERVENTION, v.13, n.4, p.432-439, 2017
Resumo
Aims: We aimed to assess the safety and performance of the DREAMS 20 scaffold up to 24 months post implant. Methods and results: The present study population comprises a total of 184 patients with 189 lesions who were enrolled in the prospective, multicentre BIOSOLVE-II and BIOSOLVE-III trials. Clinical follow-up was scheduled at one, six, 12, 24 and 36 months. The present report includes pooled follow-up data at six months and BIOSOLVE-II data at 24 months. Patients were 65.51 +/- 10.8 years old, and lesions were 12.5 +/- 5.1 mm long with reference diameters of 2.7 +/- 0.4 mm. Procedural success was obtained in 97.8%. At six months, the composite clinical endpoint target lesion failure was 3.3% (95% CI: 1.2-7.1), based on two cardiac deaths (1.1%, one unknown and one not device-related), one target vessel myocardial infarction (0.6%), and three clinically driven target lesion revascularisations (1.7%). For BIOSOLVE-II at 24 months, the target lesion failure rate was 5.9% (95% CI: 2.4-11.8), based on two cardiac deaths (1.7%), one target vessel myocardial infarction (0.9%) and four target lesion revascularisations (3.4%). There was no definite or probable scaffold thrombosis. Conclusions: The present analysis provides additional evidence on the safety of a drug-eluting absorbable metal scaffold with promising clinical outcomes up to 24 months and absence of definite or probable scaffold thrombosis.
Palavras-chave
bioresorbable scaffolds, myocardial infarction, stable angina, stent thrombosis
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