RENASCENT II: First in Human Evaluation of a Novel Sirolimus-Eluting Ultra-High Molecular Weight APTITUDE® Bioresorbable Scaffold: 9-and 24-Months Imaging and Clinical Results
Main Authors: Alaide Chieffo1, ; Saud Ahmed Khawaja2, MBBS BSc; Azeem Latib1; Boris Vesga3; Miguel Moncada4; Juan A. Delgado4; Jaime Fonseca5; Luca Testa6; Giovanni Esposito7; Marco Ferrone7; Bernardo Cortese8; Akiko Maehara9; Juan F. Granada9; Antonio Colombo1;
Collaborators: Matteo Montorfano1; Hector Hernandez10; Camilo Arana5; Antonio Dager5; Franscesco Bedogni6; Eugenio Stabile11; Mauro De Benedictis12; Emanuele Meliga12; Giuseppe Tarantini13; David Antoniucci14; Alessio La Manna15; Corrado Tamburino15;
1. Interventional Cardiology Unit, San Raffaele Hospital, Milan, Italy, Italy 2. Ospedale San Raffaele, Interventional Cardiology, Milan, Italy 3. Interventional Cardiology Unit, Instituto del Corazón, Universidad Industrial de Santander, Bucaramanga Colombia 4. EMMSA Clinica Especializada, Bello, Colombia 5. Angiografia De Occidente S.A., Cali, Colombia 6. IRCSS Policlinico San Donato 7. Division of Cardiology, Department of Advanced Biomedical Sciences, University of Naples“Federico II”, Naples, Italy 8. A.O. Fatebenefratelli, Milano, Italy 9. CRF Skirball Center for Innovation, Orangeburg, New York, United States 10. Interventional Cardiology Unit, Universidad Industrial de Santander, Bucaramanga Colombia 11. Division of Cardiology, Department of Advanced Biomedical Sciences, University of Naples “Federico II”, Naples, Italy 12. Interventional Cardiology Unit, A.O. Ordine Mauriziano Umberto I, Turin, Italy 13. Department of Cardiac, Thoracic and Vascular Sciences, University of Padua Medical School 14. A.O. Carreggi, Firenze, Italy; Division of Cardiology, Ferrarotto Hospital, University of Catania, Catania, Italy. 15. Division of Cardiology, Ferrarotto Hospital, University of Catania, Catania, Italy.
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Aims: The novel sirolimus-eluting ultra-high molecular weight 115-microns strut thickness APTITUDE® Bioreabsorbable vascular scaffold (BRS) (Amaranth Medical Inc., Mountain View, CA) displays higher mechanical strength, expansion capabilities and resistance to fracture compared to clinically available BRS technologies. RENASCENT II is a prospective, multi-center first-in-human clinical study to evaluate 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: 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 ischemia driven target lesion revascularization (TLR) at 9-and 24-months.A total of 60 patients were enrolled. All patients underwent lesion pre-dilatation 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 ± 0.26mm at 9-months and 0.3 ± 0.41mm at 24-months. At 9-months, TVF occurred in 2/59 (3.4%) due to TV-MI but no TLR. No further cases of TVF, MACE or stent thrombosis were reported upto 24-months follow-up.
Conclusions: In this multi-center prospective study, the APTITUDE® BRS was shown to be safe and effective in the treatment of single coronary lesions at 24-months clinical follow up.