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

Alaide Chieffo, Saud A. Khawaja, Boris Vesga, Hector Hernandez, Miguel Moncada, Juan A. Delgado, Giovanni Esposito, Marco Ferrone, Antonio Dager, Camilo Arana, Eugenio Stabile, Emanuele Meliga, Mauro De Benedictis, Matteo Montorfano, Azeem Latib, Jaime Fonseca, German Gomez, Corrado Tamburino, Giuseppe Tarantini, Alessio La MannaAkiko Maehara, Juan F. Granada, Antonio Colombo

Research output: Contribution to journalArticlepeer-review

Abstract

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.

Original languageEnglish (US)
Pages (from-to)48-53
Number of pages6
JournalInternational Journal of Cardiology
Volume321
DOIs
StatePublished - Dec 15 2020
Externally publishedYes

Keywords

  • Bioresorbable scaffolds
  • Optical coherence tomography
  • QCA

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

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