Two-year clinical outcomes of the "Italian diffuse/multivessel disease absorb prospective registry" (IT-DISAPPEARS).
Int J Cardiol
; 290: 21-26, 2019 09 01.
Article
em En
| MEDLINE
| ID: mdl-31104821
ABSTRACT
BACKGROUND:
Large prospective studies on the use of bioresorbable vascular scaffolds (BVS) for diffuse coronary artery disease are lacking. IT DISAPPEARS is a large multicentre prospective registry investigating the short and long-term outcomes of everolimus-eluting BVS in patients with long coronary lesions and/or multivessel coronary artery disease (ClinicalTrials.gov NCT02004730). We hereby report the 2-year outcomes of the registry.METHODS:
We enrolled 1002 patients with complex lesions undergoing implantation of 2040 BVS with a prespecified technique including predilation, correct sizing, and postdilation with non-compliant balloons. The primary endpoint was the rate of device-oriented composite endpoint (DOCE), consisting of cardiac death, target vessel-related myocardial infarction (MI), and ischaemia-driven target lesion revascularization (TLR). Secondary endpoints included 1) patient-oriented composite endpoint (POCE), consisting of all-cause mortality, all infarctions and all revascularisations; 2) definite/probable scaffold thrombosis.RESULTS:
Clinical presentation was an acute coronary syndrome in 59.8% of patients. Total BVS length implanted was 47⯱â¯22â¯mm. Postdilation of all scaffolds per patient was performed in 96.8%, while optimal implantation as per study guidelines was applied in 71.4%. Through 2-year follow-up, DOCE occurred in 9.5% of patients (cardiac death 0.6%, target vessel-related MI 5.3%, TLR 6.6%). The rate of POCE was 16.6% and of scaffold thrombosis 1.1%. Female gender, total length of coronary lesions, treatment of bifurcation lesions and use of 2.5â¯mm scaffolds were independent predictors of DOCE.CONCLUSIONS:
The 2-year results of IT-DISAPPEARS show that BVS may yield acceptable clinical outcomes in patients with complex coronary lesions when the implantation technique is appropriate.Palavras-chave
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Base de dados:
MEDLINE
Assunto principal:
Sistema de Registros
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Implantes Absorvíveis
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Síndrome Coronariana Aguda
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Stents Farmacológicos
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Everolimo
Idioma:
En
Ano de publicação:
2019
Tipo de documento:
Article