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

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. Objectives: We assessed baseline, 6- and 12-month imaging data of the drug-eluting absorbable metal scaffold (DREAMS 2G). 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 3.7 mm). 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 12 months (-0.0019; p= 0.48). The change in angulation from pre- to 12 months was negligible (-3.58 degrees; 95% CI [-5.97, -1.20]), but statistically significant. At 6 months, 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 6 months (Delta 6 months vs. post-proc. is -13.5 [ 95% CI -14.6, -12.4]) and at 12 months (Delta 12 months 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 6 months and at 12 months. Likewise, by echogenicity, hyperechogenic structures decreased significantly from post-procedure at 6 months; thereafter, they remained unchanged. Conclusion: Following implantation of DREAMS 2G, restoration of the vessel geometry, vasomotion and bioresorption signs were observed at up to 12 months; importantly, these changes occurred with preservation of the lumen size between 6 and 12 months. (C) 2017 Published by Elsevier Ireland Ltd.