TY - BOOK AU - Azizi, Viana AU - Dan, Kazuhiro AU - Garcia-Garcia, Hector M AU - Hideo-Kajita, Alexandre AU - Kuku, Kayode AU - Ozaki, Yuichi AU - Waksman, Ron TI - 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 SN - 1878-0938 PY - 2019/// KW - *Absorbable Implants KW - *Angioplasty, Balloon, Coronary/is [Instrumentation] KW - *Coronary Artery Disease/th [Therapy] KW - *Drug-Eluting Stents KW - *Magnesium KW - *Tomography, Optical Coherence KW - *Ultrasonography, Interventional KW - Adult KW - Aged KW - Angioplasty, Balloon, Coronary/ae [Adverse Effects] KW - Coronary Artery Disease/dg [Diagnostic Imaging] KW - Coronary Artery Disease/pa [Pathology] KW - Fibrosis KW - Humans KW - Middle Aged KW - Plaque, Atherosclerotic KW - Predictive Value of Tests KW - Prosthesis Design KW - Risk Factors KW - Time Factors KW - Treatment Outcome KW - Wound Healing KW - Young Adult KW - MedStar Heart & Vascular Institute KW - Journal Article N1 - Available in print through MWHC library: 2002 - present N2 - 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 0.5mm2 (p=0.017) in the proximal segment compared to baseline. In the frame-level analysis, IVUS evaluation revealed a vessel area decreased 2.80+/-1.43mm2 (p=0.012) and 2.49+/-1.53mm2 (p=0.022) in 2 proximal frames. This was accompanied by plaque area reduction of 0.88+/-0.70mm2 (p=0.048) and a FPA decreased by 0.63+/-0.48mm2 (p=0.004) in one proximal frame. In 1 distal frame, there was a dense calcium area reduction of 0.10+/-0.12mm2 (p=0.045), FPA and fibrous fatty plaque increased 0.54+/-0.53mm2 (p=0.023) and 0.17+/-0.16mm2 (p=0.016), respectively. By OCT, there was a lumen area decrease of 0.76+/-1.51mm2 (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 UR - https://dx.doi.org/10.1016/j.carrev.2019.02.019 ER -