Evaluation of the second generation of a bioresorbable XXXX -eluting vascular scaffold for the treatment of de novo coronary artery stenosis: 12-month clinical and imaging outcomes.

@entity1 @entity2239 @entity5642 @entity7452 @entity583 @entity3987
OBJECTIVES: The aim of this study was to demonstrate that the prevention of early scaffold area shrinkage of the ABSORB BVS (Rev.1.1, Abbott Vascular, Santa Clara, @entity7452 ) was sustained and not simply delayed by a few months. BACKGROUND: With improved scaffold design and modified manufacturing process of its polymer, the second iteration of ABSORB (BVS 1.1) has improved performance to prevent a scaffold area reduction at 6 months. METHODS: Fifty-six @entity1 were enrolled and received 57 ABSORB scaffolds. Quantitative coronary angiography, @entity5642 ( @entity5642 ), analysis of radiofrequency backscattering, echogenicity and optical coherence tomography (OCT) were performed at baseline and at 12-month follow-up. RESULTS: Overall the scaffold area remained unchanged with @entity5642 as well as with OCT, whereas the radiofrequency backscattering and the echogenicity of the struts decreased by 16.8% (p < 0.001) and 20% (p < 0.001), respectively; more specifically, the strut core area on OCT decreased by 11.4% (p = 0.003). Despite the absence of scaffold area loss, pharmacological vasomotion was restored. On an intention-to-treat basis, the angiographic late lumen loss amounted to 0.27    0.32 mm with an @entity5642 relative decrease in minimal lumen area of 1.94% (p = 0.12), without significant changes in mean lumen area. The OCT at follow-up showed that 96.69% of the struts were covered and that malapposition, initially observed in 18 scaffolds was only detected at follow-up in 4 scaffolds. Two @entity1 experienced peri-procedural and iatrogenic @entity583 , respectively, whereas 2 underwent repeat intervention, resulting in the major adverse cardiac event rate of 7.1% (4 of 56). CONCLUSIONS: The 12-month performance of the second-generation ABSORB bioresorbable @entity2239 -eluting scaffold justifies the conduct of a randomized trial against current @entity3987 . (A Clinical Evaluation of the Bioabsorbable @entity2239 Eluting Coronary Stent System [BVS EECSS] in the Treatment of @entity1 With de Novo Native Coronary Artery Lesions; NCT00856856).
