TY  - BOOK
AU  - Garcia-Garcia, Hector M
AU  - Haude, Michael
AU  - Hideo-Kajita, Alexandre
AU  - Kuku, Kayode
AU  - Waksman, Ron
TI  - In 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
SN  - 0167-5273
PY  - 2018///
KW  - *Absorbable Implants
KW  - *Coronary Artery Disease/dg [Diagnostic Imaging]
KW  - *Coronary Artery Disease/su [Surgery]
KW  - *Drug-Eluting Stents
KW  - *Tissue Scaffolds
KW  - *Tomography, Optical Coherence/mt [Methods]
KW  - Absorbable Implants/td [Trends]
KW  - Aged
KW  - Drug-Eluting Stents/td [Trends]
KW  - Female
KW  - Follow-Up Studies
KW  - Humans
KW  - Male
KW  - Metals
KW  - Middle Aged
KW  - Prospective Studies
KW  - Tissue Scaffolds/td [Trends]
KW  - Tomography, Optical Coherence/td [Trends]
KW  - MedStar Heart & Vascular Instituteon
KW  - Journal Article
N2  - CONCLUSION: 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; METHODS 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; OBJECTIVES: We assessed baseline, 6- and 12-month imaging data of the drug-eluting absorbable metal scaffold (DREAMS 2G); RATIONALE: 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
UR  - https://dx.doi.org/10.1016/j.ijcard.2017.12.053
ER  -