Coronary interventions

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:e133-e140. DOI: 10.4244/EIJ-D-19-00600

Alaide Chieffo
Alaide Chieffo1, MD; Saud Ahmed Khawaja1, MD; Azeem Latib1, MD; Boris Vesga2, MD; Miguel Moncada3, MD; Juan A. Delgado3, MD; Jaime Fonseca4, MD; Luca Testa5, MD; Giovanni Esposito6, MD; Marco Ferrone6, MD; Bernardo Cortese7, MD; Akiko Maehara8, MD; Juan F. Granada8, MD; Antonio Colombo1, MD
1. IRCCS, San Raffaele Hospital, Milan, Italy; 2. Interventional Cardiology Unit, Instituto del Corazón, Universidad Industrial de Santander, Bucaramanga, Santander, Colombia; 3. EMMSA Clinica Especializada, Bello, Colombia; 4. Angiografia De Occidente S.A., Cali, Colombia; 5. IRCCS Policlinico San Donato, Milan, Italy; 6. Division of Cardiology, Department of Advanced Biomedical Sciences, University of Naples “Federico II”, Naples, Italy; 7. A.O. Fatebenefratelli, Milan, Italy; 8. CRF Skirball Center for Innovation, Orangeburg, NY, USA

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.

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bioresorbable scaffoldsoptical coherence tomographyqca
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