First Report of Edge Vascular Response at 12 Months of Magmaris, A Second-Generation Drug-Eluting Resorbable Magnesium Scaffold, Assessed by Grayscale Intravascular Ultrasound, Virtual Histology, and Optical Coherence Tomography. A Biosolve-II Trial Sub-Study.
Absorbable Implants
Adult
Aged
Angioplasty, Balloon, Coronary
/ adverse effects
Coronary Artery Disease
/ diagnostic imaging
Drug-Eluting Stents
Fibrosis
Humans
Magnesium
Middle Aged
Plaque, Atherosclerotic
Predictive Value of Tests
Prosthesis Design
Risk Factors
Time Factors
Tomography, Optical Coherence
Treatment Outcome
Ultrasonography, Interventional
Wound Healing
Young Adult
Edge vascular response
Grayscale intravascular ultrasound
Magmaris
Optical coherence tomography
Virtual histology
Journal
Cardiovascular revascularization medicine : including molecular interventions
ISSN: 1878-0938
Titre abrégé: Cardiovasc Revasc Med
Pays: United States
ID NLM: 101238551
Informations de publication
Date de publication:
05 2019
05 2019
Historique:
received:
29
11
2018
revised:
11
01
2019
accepted:
13
02
2019
entrez:
14
5
2019
pubmed:
14
5
2019
medline:
19
5
2020
Statut:
ppublish
Résumé
The edge vascular response (EVR) remains unknown in second generation drug-eluting Resorbable Magnesium Scaffold (RMS), such as Magmaris. The aim of the study was to evaluate tissue modifications in the RMS edges over time, assessed by different invasive imaging modalities. The patients treated with the device were assessed by optical coherence tomography (OCT), grayscale intravascular ultrasound (IVUS), and virtual histology IVUS at baseline and 12 months. The EVR study performed a segment- and frame-level analysis of the 5 mm segments proximal and distal of the actual RMS. The segment-level grayscale IVUS (n = 10), virtual histology IVUS (n = 10), and OCT (n = 18) analysis did not show any significant changes after 12 months, except for a fibrous plaque area (FPA) reduction of 0.5mm At 12 months, Magmaris EVR assessment does not show overall significant changes, except for a fibrous plaque area reduction in the proximal segment. This could be translated as a benign healing process at the edges of the RMS. The edge vascular response (EVR) remains unknown in second generation drug-eluting absorbable metal scaffolds (RMS), such as Magmaris. Patients treated with the device were assessed by multi invasive imaging modalities [i.e. optical coherence tomography (OCT), grayscale intravascular ultrasound (IVUS), and virtual histology IVUS] evaluating the tissue changes over time in the segment- and frame-level analysis of the 5 mm segments proximal and distal of the actual RMS. As a result, after 12 months, Magmaris EVR assessment does not show overall significant changes, except for a fibrous plaque area reduction in the proximal segment, translating a benign healing process at the edges of the RMS.
Identifiants
pubmed: 31079817
pii: S1553-8389(19)30152-6
doi: 10.1016/j.carrev.2019.02.019
pii:
doi:
Substances chimiques
Magnesium
I38ZP9992A
Types de publication
Clinical Trial
Journal Article
Multicenter Study
Langues
eng
Sous-ensembles de citation
IM
Pagination
392-398Informations de copyright
Copyright © 2019 Elsevier Inc. All rights reserved.