000			04397nam a22006137a 4500
008			180118s20182018 xxu||||| |||| 00| 0 eng d
022			_a0167-5273
024			_a10.1016/j.ijcard.2017.12.053 [doi]
024			_aS0167-5273(17)36153-3 [pii]
040			_aOvid MEDLINE(R)
099			_a29292064
245			_aIn vivo serial invasive imaging of the second-generation drug-eluting absorbable metal scaffold (Magmaris - DREAMS 2G) in de novo coronary lesions: Insights from the BIOSOLVE-II First-In-Man Trial.
251			_aInternational Journal of Cardiology. 255:22-28, 2018 Mar 15.
252			_aInt J Cardiol. 255:22-28, 2018 Mar 15.
252			_zInt J Cardiol. , 2017 Dec 28
253			_aInternational journal of cardiology
260			_c2018
260			_fFY2018
266			_d2018-01-18
268			_aInternational Journal of Cardiology. , 2017 Dec 28
520			_aCONCLUSION: Following implantation of DREAMS 2G, restoration of the vessel geometry, vasomotion and bioresorption signs were observed at up to 12months; importantly, these changes occurred with preservation of the lumen size between 6 and 12months. NCT01960504. Copyright (c) 2017. Published by Elsevier B.V.
520			_aMETHODS AND RESULTS: The international, first-in-man BIOSOLVE-II trial enrolled 123 patients with up to 2 de novo lesions (in vessels of 2.2 to 3.7mm). Angiographic based vasomotion, curvature and angulation were assessed; intravascular ultrasound (IVUS) derived radiofrequency (RF) data analysis and echogenicity were evaluated; optical coherence tomography (OCT) attenuation and backscattering analysis were also performed. There was hardly any difference in curvature between pre-procedure and 12months (-0.0019; p=0.48). The change in angulation from pre- to 12months was negligible (-3.58degree; 95% CI [-5.97, -1.20]), but statistically significant. At 6months, the change in QCA based minimum lumen diameter in response to high dose of acetylcholine and IVUS-RF necrotic core percentage showed an inverse relationship (estimate of -0.489; p=0.055) and with fibrous volume a positive relationship (estimate of 0.53, p=0.035). Bioresorption analysis by OCT showed that the maximum attenuation values decreased significantly from post-procedure at 6months (DELTA 6months vs. post-proc. is -13.5 [95% CI -14.6, -12.4]) and at 12months (DELTA 12months vs. post-proc. is -14.0 [95% CI -15.4, -12.6]). By radiofrequency data, the percentage of dense calcium decreased significantly from post-procedure at 6months and at 12months. Likewise, by echogenicity, hyperechogenic structures decreased significantly from post-procedure at 6months; thereafter, they remained unchanged.
520			_aOBJECTIVES: We assessed baseline, 6- and 12-month imaging data of the drug-eluting absorbable metal scaffold (DREAMS 2G).
520			_aRATIONALE: Bioresorbable scaffolds may confer clinical benefit in long-term studies; early mechanistic studies using intravascular imaging have provided insightful information about the immediate and mid-term local serial effects of BRS on the coronary vessel wall.
546			_aEnglish
650			_a*Absorbable Implants
650			_a*Coronary Artery Disease/dg [Diagnostic Imaging]
650			_a*Coronary Artery Disease/su [Surgery]
650			_a*Drug-Eluting Stents
650			_a*Tissue Scaffolds
650			_a*Tomography, Optical Coherence/mt [Methods]
650			_aAbsorbable Implants/td [Trends]
650			_aAged
650			_aDrug-Eluting Stents/td [Trends]
650			_aFemale
650			_aFollow-Up Studies
650			_aHumans
650			_aMale
650			_aMetals
650			_aMiddle Aged
650			_aProspective Studies
650			_aTissue Scaffolds/td [Trends]
650			_aTomography, Optical Coherence/td [Trends]
651			_aMedStar Heart & Vascular Instituteon
657			_aJournal Article
700			_aGarcia-Garcia, Hector M
700			_aHaude, Michael
700			_aHideo-Kajita, Alexandre
700			_aKuku, Kayode
700			_aWaksman, Ron
790			_aAbizaid A, Christiansen EH, Dijkstra J, Escaned J, Garcia-Garcia HM, Haude M, Hideo-Kajita A, Ince H, Kuku K, Lemos PA, Tolg R, von Birgelen C, Waksman R, Wijns W
856			_uhttps://dx.doi.org/10.1016/j.ijcard.2017.12.053 _zhttps://dx.doi.org/10.1016/j.ijcard.2017.12.053
942			_cART _dArticle
999			_c2968 _d2968