Randomized Comparison of Absorb Bioresorbable Vascular Scaffold and Mirage Microfiber Sirolimus-Eluting Scaffold Using Multimodality Imaging.

摘要: Abstract Objectives The primary objective of this study was to evaluate the safety and effectiveness Mirage (Manli Cardiology, Singapore) bioresorbable microfiber sirolimus-eluting scaffold compared with Absorb (Abbott Vascular, Santa Clara, California) vascular in treatment stenotic target lesions located native coronary arteries, ranging from ≥2.25 to ≤4.0 mm diameter. Secondary objectives were establish medium-term safety, effectiveness, performance device. Background current generation scaffolds has several limitations, such as thick square struts large footprints that preclude their deep embedment into vessel wall, resulting protrusion lumen microdisturbance flow. is designed address these concerns. Methods In prospective, single-blind trial, 60 patients randomly allocated a 1:1 ratio or an scaffold. clinical endpoints assessed at 30 days 6 12 months. In-device angiographic late loss months quantified. optical coherence tomographic post–scaffold implantation Results Median post-procedural in-scaffold minimal luminal diameters devices 2.38 (interquartile range [IQR]: 2.06 2.62 mm) 2.55 (IQR: 2.26 2.71 mm), respectively; effect size (d) was −0.29. At months, median not statistically different (1.90 [IQR: 1.57 2.31 mm] vs. 2.29 1.74 2.51 mm], d = −0.36). 12-month follow-up, 0.37 mm 0.08 0.72 0.23 0.15 0.37 respectively (d = 0.20). On tomography, diameter stenosis 11.2 ± 7.1%, which increased 27.4 12.4% 6 months remained stable (31.8 12.9%) 1 year, whereas 8.4 6.6%, 16.6 8.9% (21.2 9.9%) 1-year follow-up (Mirage Absorb: dpost-procedure = 0.41, d6 months = 1.00, d12 0.92). Angiographic significantly between groups (28.6% 21.0% 40.7%] for Mirage, 18.2% 13.1% 31.6%] Absorb, d = 0.39). Device- patient-oriented composite comparable 2 groups. Conclusions devices, although on angiography tomography higher than Absorb. technique suboptimal both future trials should incorporate guidance allow optimal appropriate assessment new technology, considering novel mechanical properties Mirage.