First in human evaluation of a novel Sirolimus-eluting ultra-high molecular weight bioresorbable scaffold: 9-, 24-and 36-months imaging and clinical results from the multi-center RENASCENT study

Background: RENASCENT is a prospective, multi-center first-in-human clinical study to evaluate the clinical performance of the novel sirolimus-eluting 150-mu m strut thickness FORTITUDE (R) BRS for percutaneous coronary intervention of single de novo coronary lesions. Methods: FORTITUDE (R) BRS was tested in a prospective study in Italy and Colombia. Study objectives were inscaffold 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 patientswere 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 patientwho presented with very late ST after stopping allmedications. There were no further TVF between 24- and 36-months. Conclusions: In thismulti-center prospective study, the FORTITUDE (R) BRSwas shown to be safe and effective in the treatment of single coronary lesionswith lowlevels of TVF and LLL at 9- and 24-months. Itwas shown to be clinically safe upto 36-months follow-up. (C) 2020 Published by Elsevier B.V.