05526nam a22007577a 4500008004200000022001400042024003900056024003200095040002000127099001300147245026400160251007100424252005100495252005200546253008200598260000900680260001100689265001300700266001500713268007200728501006000800520024200860520005801102520030701160520031801467520095901785520071102744546001203455650002503467650005703492650004203549650002503591650001503616650003503631650003703666650001003703650000903713650005603722650005203778650004303830650001303873650001103886650001603897650002803913650003003941650002203971650001703993650001704010650002204027650001804049650001604067651003904083657002004122700001704142700001804159700002804177700002804205700001704233700001804250700001704268790024404285856010104529942001704630952010604647999001504753190521s20192019 xxu||||| |||| 00| 0 eng d a1878-0938 a10.1016/j.carrev.2019.02.019 [doi] aS1553-8389(19)30152-6 [pii] aOvid MEDLINE(R) a31079817 aFirst 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. aCardiovascular Revascularization Medicine. 20(5):392-398, 2019 05. aCardiovasc Revasc Med. 20(5):392-398, 2019 05. zCardiovasc Revasc Med. 20(5):392-398, 2019 May. aCardiovascular revascularization medicine : including molecular interventions c2019 fFY2019 sppublish d2019-05-21 aCardiovascular Revascularization Medicine. 20(5):392-398, 2019 May. aAvailable in print through MWHC library: 2002 - present aCONCLUSION: 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. aCopyright (c) 2019 Elsevier Inc. All rights reserved. aINTRODUCTION 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. aMETHODS: 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. aRESULTS: 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. aSUMMARY: 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. aEnglish a*Absorbable Implants a*Angioplasty, Balloon, Coronary/is [Instrumentation] a*Coronary Artery Disease/th [Therapy] a*Drug-Eluting Stents a*Magnesium a*Tomography, Optical Coherence a*Ultrasonography, Interventional aAdult aAged aAngioplasty, Balloon, Coronary/ae [Adverse Effects] aCoronary Artery Disease/dg [Diagnostic Imaging] aCoronary Artery Disease/pa [Pathology] aFibrosis aHumans aMiddle Aged aPlaque, Atherosclerotic aPredictive Value of Tests aProsthesis Design aRisk Factors aTime Factors aTreatment Outcome aWound Healing aYoung Adult aMedStar Heart & Vascular Institute aJournal Article aAzizi, Viana aDan, Kazuhiro aGarcia-Garcia, Hector M aHideo-Kajita, Alexandre aKuku, Kayode aOzaki, Yuichi aWaksman, Ron aAbizaid 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 W uhttps://dx.doi.org/10.1016/j.carrev.2019.02.019zhttps://dx.doi.org/10.1016/j.carrev.2019.02.019 cARTdArticle 001040708Articleaauthcatbauthcatd2019-05-21l0o31079817p31079817r2019-05-21w2019-05-21yART c4238d4238