First-in-human evaluation of a novel sirolimus-eluting ultra-high molecular weight APTITUDE bioresorbable scaffold: 9- and 24-month imaging and clinical results of the RENASCENT II trial.
Autores da FMUP
Participantes de fora da FMUP
- Chieffo A
- Khawaja SA
- Latib A
- Vesga B
- Moncada M
- Delgado JA
- Testa L
- Esposito G
- Ferrone M
- Cortese B
- Maehara A
- Granada JF
- Colombo A
- Collaborators
Unidades de investigação
Abstract
AIMS: The novel sirolimus-eluting ultra-high molecular weight APTITUDE bioreabsorbable vascular scaffold (BRS) displays higher mechanical strength, expansion capabilities and resistance to fracture compared to other BRS technologies. RENASCENT II is a prospective, multicentre first-in-human clinical study evaluating the clinical performance of the APTITUDE BRS in the treatment of single de novo coronary lesions among patients undergoing percutaneous coronary intervention. METHODS AND RESULTS: The APTITUDE BRS was tested in a prospective study in two countries (Italy and Colombia). Study objectives were angiographic in-scaffold late lumen loss (IS-LLL) measured by quantitative coronary angiography (QCA) and target vessel failure (TVF) defined as the composite rate of cardiac death, target vessel myocardial infarction (TV-MI) or ischaemia-driven target lesion revascularisation (TLR) at 9 and 24 months. A total of 60 patients were enrolled. All patients underwent lesion predilatation and 46 patients (76.7%) underwent post-dilatation. Clinical device and procedural success were 98.3% (59/60 patients) and 100%, respectively. Angiographic late lumen loss was 0.19±0.26 mm at 9 months and 0.3±0.41 mm at 24 months. At 9 months, TVF occurred in 2/59 patients (3.4%) due to TV-MI but there was no TLR. No further cases of TVF, MACE or stent thrombosis were reported up to 24-month follow-up. CONCLUSIONS: In this multicentre prospective study, the APTITUDE BRS was shown to be safe and effective in the treatment of single coronary lesions at 24-month clinical follow-up.
Dados da publicação
- ISSN/ISSNe:
- 1774-024X, 1969-6213
- Tipo:
- Article
- Páginas:
- -
EuroIntervention EuroPCR
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Utilização em estudos observacionais do Registo de Asma Grave Portugal.
Investigador Principal: João de Almeida Lopes da Fonseca
Estudo Observacional Académico (RAG) . 2020
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Chieffo A,Khawaja SA,Latib A,Vesga B,Moncada M,Delgado JA,Fonseca J,Testa L,Esposito G,Ferrone M,Cortese B,Maehara A,Granada JF,Colombo A,C. First-in-human evaluation of a novel sirolimus-eluting ultra-high molecular weight APTITUDE bioresorbable scaffold: 9- and 24-month imaging and clinical results of the RENASCENT II trial. EuroIntervention. 2020. 16. (2):e133-e140. IF:6,534. (1).