The ABSORB EXTEND study: preliminary report of the twelve-month clinical outcomes in the first 512 patients enrolled
EuroIntervention
; 10(12): 1396-1401, 2015. tab
Artigo
em Inglês
| Sec. Est. Saúde SP, SESSP-IDPCPROD, Sec. Est. Saúde SP
| ID: biblio-1062689
Biblioteca responsável:
BR79.1
Localização: BR79.1
ABSTRACT
Aims:
The safety and performance of the Absorb Bioresorbable Vascular Scaffold (Absorb BVS) system(Abbott Vascular, Santa Clara, CA, USA) has been previously established in 131 patients from cohort A andcohort B of the first-in-man ABSORB trial. Following this trial, ABSORB EXTEND was initiated as a globalcontinued access study (outside of the USA) to expand experience with the Absorb BVS system to differentgeographies with broader inclusion criteria to include the treatment of longer lesions and multiple vessels.We report in this manuscript the twelve-month clinical outcomes of the first 512 patients in this population.Methods andresults:
ABSORB EXTEND is a prospective, single-arm, open-label clinical study whichwill enrol up to 800 patients at up to 100 sites. Included are patients with lesions ≤28 mm in length and referencevessel diameter of 2.0-3.8 mm (as assessed by on-line QCA or IVUS). Treatment of a maximum oftwo de novo native coronary artery lesions is permitted when each lesion is located in a different epicardialvessel. An independent clinical events committee adjudicates all endpoint-related events. At one year, for thefirst 512 patients enrolled in the study, the composite endpoints of ischaemia-driven MACE and ischaemiadriventarget vessel failure were 4.3% and 4.9%, respectively. The cumulative rate of ARC defined definiteand probable scaffold thrombosis for this population was 0.8% at one year.Conclusions:
This interim analysis of the ABSORB EXTEND study shows low rates of MACE and scaffoldthrombosis. The study is registered on clinicaltrials.gov (unique identifier NCT01023789).
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Coleções:
Bases de dados nacionais
/
Brasil
Base de dados:
Sec. Est. Saúde SP
/
SESSP-IDPCPROD
Assunto principal:
Doença da Artéria Coronariana
/
Stents Farmacológicos
/
Intervenção Coronária Percutânea
Tipo de estudo:
Estudo prognóstico
Idioma:
Inglês
Revista:
EuroIntervention
Ano de publicação:
2015
Tipo de documento:
Artigo
Instituição/País de afiliação:
Abbott Vascular/BE
/
Abbott Vascular/US
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Erasmus University Medical Center/NL
/
Fortis Escorts Heart Institute/IN
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Institut Cardiovasculaire Paris Sud/FR
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Instituto Dante Pazzanese de Cardiologia/BR
/
Instituto Dante Pazzanese de Cardiologia/BR
/
Krishna Heart Institute/IN
/
St Vincents Hospital/AU
/
University of Milan/IT