First Report of Edge Vascular Response at 12Months 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.

MedStar author(s):
Citation: Cardiovascular Revascularization Medicine. 20(5):392-398, 2019 05.PMID: 31079817Institution: MedStar Heart & Vascular InstituteForm of publication: Journal ArticleMedline article type(s): Journal ArticleSubject headings: *Absorbable Implants | *Angioplasty, Balloon, Coronary/is [Instrumentation] | *Coronary Artery Disease/th [Therapy] | *Drug-Eluting Stents | *Magnesium | *Tomography, Optical Coherence | *Ultrasonography, Interventional | Adult | Aged | Angioplasty, Balloon, Coronary/ae [Adverse Effects] | Coronary Artery Disease/dg [Diagnostic Imaging] | Coronary Artery Disease/pa [Pathology] | Fibrosis | Humans | Middle Aged | Plaque, Atherosclerotic | Predictive Value of Tests | Prosthesis Design | Risk Factors | Time Factors | Treatment Outcome | Wound Healing | Young AdultYear: 2019Local holdings: Available in print through MWHC library: 2002 - presentISSN:
  • 1878-0938
Name of journal: Cardiovascular revascularization medicine : including molecular interventionsAbstract: CONCLUSION: At 12months, 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.Copyright (c) 2019 Elsevier Inc. All rights reserved.INTRODUCTION AND OBJECTIVE: 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.METHODS: The patients treated with the device were assessed by optical coherence tomography (OCT), grayscale intravascular ultrasound (IVUS), and virtual histology IVUS at baseline and 12months. The EVR study performed a segment- and frame-level analysis of the 5mm segments proximal and distal of the actual RMS.RESULTS: The segment-level grayscale IVUS (n=10), virtual histology IVUS (n=10), and OCT (n=18) analysis did not show any significant changes after 12months, 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+/-1.43mm<sup>2</sup> (p=0.012) and 2.49+/-1.53mm<sup>2</sup> (p=0.022) in 2 proximal frames. This was accompanied by plaque area reduction of 0.88+/-0.70mm<sup>2</sup> (p=0.048) and a FPA decreased by 0.63+/-0.48mm<sup>2</sup> (p=0.004) in one proximal frame. In 1 distal frame, there was a dense calcium area reduction of 0.10+/-0.12mm<sup>2</sup> (p=0.045), FPA and fibrous fatty plaque increased 0.54+/-0.53mm<sup>2</sup> (p=0.023) and 0.17+/-0.16mm<sup>2</sup> (p=0.016), respectively. By OCT, there was a lumen area decrease of 0.76+/-1.51mm<sup>2</sup> (p=0.045) in a distal frame.SUMMARY: 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 5mm segments proximal and distal of the actual RMS. As a result, after 12months, 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.All authors: Abizaid A, Azizi V, Christiansen EH, Dan K, Eeckhout E, Escaned J, Garcia-Garcia HM, Haude M, Hideo-Kajita A, Ince H, Joner M, Kaiser C, Koolen J, Kuku KO, Lemos PA, Neumann FJ, Ozaki Y, Teik LS, Toelg R, von Birgelen C, Waksman R, Wijns WOriginally published: Cardiovascular Revascularization Medicine. 20(5):392-398, 2019 May.Fiscal year: FY2019Digital Object Identifier: Date added to catalog: 2019-05-21
Holdings
Item type Current library Collection Call number Status Date due Barcode
Journal Article MedStar Authors Catalog Article 31079817 Available 31079817

Available in print through MWHC library: 2002 - present

CONCLUSION: At 12months, 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.

Copyright (c) 2019 Elsevier Inc. All rights reserved.

INTRODUCTION AND OBJECTIVE: 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.

METHODS: The patients treated with the device were assessed by optical coherence tomography (OCT), grayscale intravascular ultrasound (IVUS), and virtual histology IVUS at baseline and 12months. The EVR study performed a segment- and frame-level analysis of the 5mm segments proximal and distal of the actual RMS.

RESULTS: The segment-level grayscale IVUS (n=10), virtual histology IVUS (n=10), and OCT (n=18) analysis did not show any significant changes after 12months, 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+/-1.43mm<sup>2</sup> (p=0.012) and 2.49+/-1.53mm<sup>2</sup> (p=0.022) in 2 proximal frames. This was accompanied by plaque area reduction of 0.88+/-0.70mm<sup>2</sup> (p=0.048) and a FPA decreased by 0.63+/-0.48mm<sup>2</sup> (p=0.004) in one proximal frame. In 1 distal frame, there was a dense calcium area reduction of 0.10+/-0.12mm<sup>2</sup> (p=0.045), FPA and fibrous fatty plaque increased 0.54+/-0.53mm<sup>2</sup> (p=0.023) and 0.17+/-0.16mm<sup>2</sup> (p=0.016), respectively. By OCT, there was a lumen area decrease of 0.76+/-1.51mm<sup>2</sup> (p=0.045) in a distal frame.

SUMMARY: 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 5mm segments proximal and distal of the actual RMS. As a result, after 12months, 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.

English

Powered by Koha