MedStar Authors catalog › Details for: 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.
Citation: ; International Journal of Cardiology. 255:22-28, 2018 Mar 15..Journal: International journal of cardiology.Published: 2018ISSN: 0167-5273.Full author list: Garcia-Garcia HM; Haude M; Kuku K; Hideo-Kajita A; Ince H; Abizaid A; Tolg R; Lemos PA; von Birgelen C; Christiansen EH; Wijns W; Escaned J; Dijkstra J; Waksman R.UI/PMID: 29292064.Subject(s): Absorbable Implants/td [Trends] | *Absorbable Implants | Aged | *Coronary Artery Disease/dg [Diagnostic Imaging] | *Coronary Artery Disease/su [Surgery] | Drug-Eluting Stents/td [Trends] | *Drug-Eluting Stents | Female | Follow-Up Studies | Humans | Male | Metals | Middle Aged | Prospective Studies | Tissue Scaffolds/td [Trends] | *Tissue Scaffolds | *Tomography, Optical Coherence/mt [Methods] | Tomography, Optical Coherence/td [Trends]Institution(s): MedStar Heart & Vascular InstituteonActivity type: Journal Article.Medline article type(s): Journal ArticleDigital Object Identifier: https://dx.doi.org/10.1016/j.ijcard.2017.12.053 (Click here)Abbreviated citation: ; Int J Cardiol. 255:22-28, 2018 Mar 15.Abstract: 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.Abstract: OBJECTIVES: We assessed baseline, 6- and 12-month imaging data of the drug-eluting absorbable metal scaffold (DREAMS 2G).Abstract: 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.Abstract: 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.