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.

Data de publicação: Data Ahead of Print:

Autores da FMUP

  • João De Almeida Lopes Da Fonseca

    Autor

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

EuroIntervention  EuroPCR

Tipo:
Article
Páginas:
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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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