TY - JOUR
T1 - Evaluation of the second generation of a bioresorbable everolimus-eluting vascular scaffold for the treatment of de novo coronary artery stenosis: 12-month clinical and imaging outcomes
AU - Serruys, Patrick
AU - Onuma, Yoshinobu
AU - Dudek, Dariusz
AU - Smits, Pieter
AU - Koolen, Jacques
AU - Chevalier, Bernard
AU - de Bruyne, Bernard
AU - Thuesen, Leif
AU - McClean, Dougal
AU - van Geuns, Robert-Jan
AU - Windecker, Stephan
AU - Whitbourn, Robert
AU - Meredith, Ian
AU - Dorange, Cecile
AU - Veldhof, Susan
AU - Hebert, Karine
AU - Sudhir, Krishnankutty
AU - Garcia-Garcia, Hector
AU - Ormiston, John
PY - 2011
Y1 - 2011
N2 - 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, California) 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 patients were enrolled and received 57 ABSORB scaffolds. Quantitative coronary angiography, intravascular ultrasound (IVUS), 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 IVUS 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 IVUS 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 patients experienced peri-procedural and iatrogenic myocardial infarction, 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 everolimus-eluting scaffold justifies the conduct of a randomized trial against current best standards. (A Clinical Evaluation of the Bioabsorbable Everolimus Eluting Coronary Stent System [BVS EECSS] i
AB - 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, California) 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 patients were enrolled and received 57 ABSORB scaffolds. Quantitative coronary angiography, intravascular ultrasound (IVUS), 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 IVUS 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 IVUS 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 patients experienced peri-procedural and iatrogenic myocardial infarction, 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 everolimus-eluting scaffold justifies the conduct of a randomized trial against current best standards. (A Clinical Evaluation of the Bioabsorbable Everolimus Eluting Coronary Stent System [BVS EECSS] i
UR - http://www.ncbi.nlm.nih.gov/pubmed/21958884
U2 - 10.1016/j.jacc.2011.05.050
DO - 10.1016/j.jacc.2011.05.050
M3 - Article
SN - 0735-1097
VL - 58
SP - 1578
EP - 1588
JO - Journal of the American College of Cardiology
JF - Journal of the American College of Cardiology
IS - 15
ER -