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.

Absorbable Implants Cardiovascular Agents / therapeutic use Colombia Coronary Angiography Coronary Artery Disease / diagnostic imaging Coronary Restenosis / drug therapy Drug-Eluting Stents Humans Italy Molecular Weight Percutaneous Coronary Intervention Prospective Studies Prosthesis Design Sirolimus Tomography, Optical Coherence Treatment Outcome

Bioresorbable scaffolds Optical coherence tomography QCA

Journal

International journal of cardiology

ISSN: 1874-1754

Titre abrégé: Int J Cardiol

Pays: Netherlands

ID NLM: 8200291

Informations de publication

Date de publication:
15 Dec 2020

Historique:

received: 02 02 2020

revised: 05 07 2020

accepted: 07 08 2020

pubmed: 19 8 2020

medline: 15 5 2021

entrez: 19 8 2020

Statut: ppublish

Résumé

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. 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. 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. 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.

Sections du résumé

BACKGROUND BACKGROUND

METHODS 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 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 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.

Identifiants

DOI: 10.1016/j.ijcard.2020.08.014 PMID: 32810542

pubmed: 32810542

pii: S0167-5273(20)33541-5

doi: 10.1016/j.ijcard.2020.08.014

pii:

doi:

Substances chimiques

Cardiovascular Agents 0

Sirolimus W36ZG6FT64

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

Pagination

48-53

Informations de copyright

Déclaration de conflit d'intérêts

Declaration of Competing Interest Alaide Chieffo, MD: Proctorship fees from Amaranth Medical Inc. Juan F. Granada, MD: Scientific advisor and equity shareholder Amaranth Medical Inc. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.