Five-year angiographic, OCT and clinical outcomes of a randomized comparison of everolimus and biolimus-eluting coronary stents with everolimus-eluting bioresorbable vascular scaffolds.
Catheter Cardiovasc Interv
; 99(3): 523-532, 2022 02.
Article
em En
| MEDLINE
| ID: mdl-34173699
ABSTRACT
AIMS:
To compare 5-year angiographic, optical coherence tomography (OCT), and clinical outcomes between patients treated with bioresorbable vascular scaffolds (BVS) and drug-eluting stents (DES).METHODS:
The EverBio-2 trial (Comparison of Everolimus- and Biolimus-Eluting Coronary Stents with Everolimus-Eluting Bioresorbable Vascular Scaffold) was a single-center, assessor-blinded, randomized controlled trial in which 240 patients were randomly allocated (111) to BVS, everolimus-eluting (EES) or biolimus-eluting (BES) DES. Clinical follow-up was scheduled up to 5 years. All patients, alive and who did not have repeat revascularization of the target lesion during follow-up were asked to return for angiographic follow-up at 5 years.RESULTS:
Five-year angiographic follow-up was completed in 122 patients (51%) and OCT analysis was performed in 86 (36%) patients. In-stent late lumen loss was similar in both groups with 0.50 ± 0.38 mm in BVS versus 0.58 ± 0.36 mm in EES/BES, p = 0.20. Clinical follow-up was complete in 232 patients (97%) at 5 years. The rate of the device-oriented endpoint was 22% in the BVS and 18% in the EES/BES group (p = 0.49). The patient-oriented composite endpoint occurred in 40% of BVS- and 43% of EES/BES-treated patients (p = 0.72) at 5 years. No acute coronary syndrome due to stent thrombosis was detected after 2 years. Complete BVS strut resorption was observed at 5 years in the OCT subgroup.CONCLUSION:
Five-year clinical outcomes were similar between BVS and DES patients as well as angiographic outcomes in a selected subgroup. However, a definitive conclusion cannot be drawn because the EverBio-2 trial was not powered for clinical and angiographic endpoints at 5 years of follow-up.Palavras-chave
Texto completo:
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Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Stents Farmacológicos
/
Intervenção Coronária Percutânea
Tipo de estudo:
Clinical_trials
Limite:
Humans
Idioma:
En
Revista:
Catheter Cardiovasc Interv
Assunto da revista:
CARDIOLOGIA
Ano de publicação:
2022
Tipo de documento:
Article
País de afiliação:
Suíça