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
Article
en En
| SES-SP, SESSP-IDPCPROD, SES-SP
| ID: biblio-1062689
Biblioteca responsable:
BR79.1
Ubicación: 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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Colección:
06-national
/
BR
Base de datos:
SES-SP
/
SESSP-IDPCPROD
Asunto principal:
Enfermedad de la Arteria Coronaria
/
Stents Liberadores de Fármacos
/
Intervención Coronaria Percutánea
Tipo de estudio:
Prognostic_studies
Idioma:
En
Revista:
EuroIntervention
Año:
2015
Tipo del documento:
Article