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.

Details

Serval ID
serval:BIB_33BDF5807565
Type
Article: article from journal or magazin.
Collection
Publications
Institution
Title
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.
Journal
Cardiovascular revascularization medicine
Author(s)
Hideo-Kajita A., Garcia-Garcia H.M., Haude M., Joner M., Koolen J., Ince H., Abizaid A., Toelg R., Lemos P.A., von Birgelen C., Christiansen E.H., Wijns W., Neumann F.J., Kaiser C., Eeckhout E., Teik L.S., Escaned J., Azizi V., Kuku K.O., Ozaki Y., Dan K., Waksman R.
ISSN
1878-0938 (Electronic)
ISSN-L
1878-0938
Publication state
Published
Issued date
05/2019
Peer-reviewed
Oui
Volume
20
Number
5
Pages
392-398
Language
english
Notes
Publication types: Clinical Trial ; Journal Article ; Multicenter Study
Publication Status: ppublish
Abstract
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 <sup>2</sup> (p = 0.017) in the proximal segment compared to baseline. In the frame-level analysis, IVUS evaluation revealed a vessel area decreased 2.80 ± 1.43 mm <sup>2</sup> (p = 0.012) and 2.49 ± 1.53 mm <sup>2</sup> (p = 0.022) in 2 proximal frames. This was accompanied by plaque area reduction of 0.88 ± 0.70 mm <sup>2</sup> (p = 0.048) and a FPA decreased by 0.63 ± 0.48 mm <sup>2</sup> (p = 0.004) in one proximal frame. In 1 distal frame, there was a dense calcium area reduction of 0.10 ± 0.12 mm <sup>2</sup> (p = 0.045), FPA and fibrous fatty plaque increased 0.54 ± 0.53 mm <sup>2</sup> (p = 0.023) and 0.17 ± 0.16 mm <sup>2</sup> (p = 0.016), respectively. By OCT, there was a lumen area decrease of 0.76 ± 1.51 mm <sup>2</sup> (p = 0.045) in a distal frame.
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.
Keywords
Absorbable Implants, Adult, Aged, Angioplasty, Balloon, Coronary/adverse effects, Angioplasty, Balloon, Coronary/instrumentation, Coronary Artery Disease/diagnostic imaging, Coronary Artery Disease/pathology, Coronary Artery Disease/therapy, 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
Pubmed
Web of science
Create date
03/06/2019 8:24
Last modification date
23/06/2020 5:21
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