TY - JOUR
T1 - First in human evaluation of a novel Sirolimus-eluting ultra-high molecular weight bioresorbable scaffold
T2 - 9-, 24-and 36-months imaging and clinical results from the multi-center RENASCENT study
AU - Chieffo, Alaide
AU - Khawaja, Saud A.
AU - Vesga, Boris
AU - Hernandez, Hector
AU - Moncada, Miguel
AU - Delgado, Juan A.
AU - Esposito, Giovanni
AU - Ferrone, Marco
AU - Dager, Antonio
AU - Arana, Camilo
AU - Stabile, Eugenio
AU - Meliga, Emanuele
AU - De Benedictis, Mauro
AU - Montorfano, Matteo
AU - Latib, Azeem
AU - Fonseca, Jaime
AU - Gomez, German
AU - Tamburino, Corrado
AU - Tarantini, Giuseppe
AU - La Manna, Alessio
AU - Maehara, Akiko
AU - Granada, Juan F.
AU - Colombo, Antonio
N1 - Funding Information:
This study was funded by Amaranth Medical Inc , USA.
Publisher Copyright:
© 2020
Copyright:
Copyright 2020 Elsevier B.V., All rights reserved.
PY - 2020/12/15
Y1 - 2020/12/15
N2 - Background: RENASCENT is a prospective, multi-center first-in-human clinical study to evaluate the clinical performance of the novel sirolimus-eluting 150-μm strut thickness FORTITUDE® BRS for percutaneous coronary intervention of single de novo coronary lesions. Methods: FORTITUDE® BRS was tested in a prospective study in Italy and Colombia. Study objectives were in-scaffold angiographic late lumen loss (LLL) measured by quantitative coronary angiography and target vessel failure (TVF) defined as the composite rate of cardiac death, target vessel myocardial infarction or ischemia driven target lesion revascularization (TLR) at 9- and 24-months with clinical results up to 36-months. Results: A total of 63 patients were enrolled. All patients underwent lesion pre-dilatation and 22 patients (34.9%) underwent post-dilatation. Clinical device and procedural success was 98.4% (62/63 patients) and 96.8% (61/63 patients) respectively. At 9-months, TVF occurred in 3/61 (4.9%) of the patients including 2 peri-procedural MI and one ischemia-driven TLR. Between 9- to 24-months, ischemia-driven TLR occurred in 3 additional patients (4.9%) including 1 patient who presented with very late ST after stopping all medications. There were no further TVF between 24- and 36-months. Conclusions: In this multi-center prospective study, the FORTITUDE® BRS was shown to be safe and effective in the treatment of single coronary lesions with low levels of TVF and LLL at 9- and 24-months. It was shown to be clinically safe upto 36-months follow-up.
AB - Background: RENASCENT is a prospective, multi-center first-in-human clinical study to evaluate the clinical performance of the novel sirolimus-eluting 150-μm strut thickness FORTITUDE® BRS for percutaneous coronary intervention of single de novo coronary lesions. Methods: FORTITUDE® BRS was tested in a prospective study in Italy and Colombia. Study objectives were in-scaffold angiographic late lumen loss (LLL) measured by quantitative coronary angiography and target vessel failure (TVF) defined as the composite rate of cardiac death, target vessel myocardial infarction or ischemia driven target lesion revascularization (TLR) at 9- and 24-months with clinical results up to 36-months. Results: A total of 63 patients were enrolled. All patients underwent lesion pre-dilatation and 22 patients (34.9%) underwent post-dilatation. Clinical device and procedural success was 98.4% (62/63 patients) and 96.8% (61/63 patients) respectively. At 9-months, TVF occurred in 3/61 (4.9%) of the patients including 2 peri-procedural MI and one ischemia-driven TLR. Between 9- to 24-months, ischemia-driven TLR occurred in 3 additional patients (4.9%) including 1 patient who presented with very late ST after stopping all medications. There were no further TVF between 24- and 36-months. Conclusions: In this multi-center prospective study, the FORTITUDE® BRS was shown to be safe and effective in the treatment of single coronary lesions with low levels of TVF and LLL at 9- and 24-months. It was shown to be clinically safe upto 36-months follow-up.
KW - Bioresorbable scaffolds
KW - Optical coherence tomography
KW - QCA
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U2 - 10.1016/j.ijcard.2020.08.014
DO - 10.1016/j.ijcard.2020.08.014
M3 - Article
C2 - 32810542
AN - SCOPUS:85090062991
VL - 321
SP - 48
EP - 53
JO - International Journal of Cardiology
JF - International Journal of Cardiology
SN - 0167-5273
ER -