First-in-human evaluation of the novel sirolimus-eluting ultrahigh molecular weight APTITUDE bioresorbable scaffold: 9- And 24-month imaging and clinical results of the RENASCENT II trial

Alaide Chieffo, Saud A. Khawaja, Azeem Latib, Boris Vesga, Miguel Moncada, Juan A. Delgado, Jaime Fonseca, Luca Testa, Giovanni Esposito, Marco Ferrone, Bernardo Cortese, Akiko Maehara, Juan F. Granada, Antonio Colombo, Matteo Montorfano, Hector Hernandez, Camilo Arana, Antonio Dager, Francesco Bedogni, Eugenio StabileMauro de Benedictis, Emanuele Meliga, Giuseppe Tarantini, David Antoniucci, Alessio la Manna, Corrado Tamburino

Research output: Contribution to journalArticlepeer-review

3 Scopus citations

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.

Original languageEnglish (US)
Pages (from-to)E133-E140
JournalEuroIntervention
Volume16
Issue number2
DOIs
StatePublished - 2021
Externally publishedYes

Keywords

  • Bioresorbable scaffolds
  • Optical coherence tomography
  • QCA

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

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