TY - JOUR
T1 - Vascular response of the segments adjacent to the proximal and distal edges of the ABSORB everolimus-eluting bioresorbable vascular scaffold
T2 - 6-Month and 1-year follow-up assessment - A virtual histology intravascular ultrasound study from the first-in-man ABSORB cohort B trial
AU - Gogas, Bill D.
AU - Serruys, Patrick W.
AU - Diletti, Roberto
AU - Farooq, Vasim
AU - Brugaletta, Salvatore
AU - Radu, Maria D.
AU - Heo, Jung Ho
AU - Onuma, Yoshinobu
AU - Van Geuns, Robert Jan M.
AU - Regar, Evelyn
AU - De Bruyne, Bernard
AU - Chevalier, Bernard
AU - Thuesen, Leif
AU - Smits, Pieter C.
AU - Dudek, Dariusz
AU - Koolen, Jacques
AU - Windecker, Stefan
AU - Whitbourn, Robert
AU - Miquel-Hebert, Karine
AU - Dorange, Cecile
AU - Rapoza, Richard
AU - Garcia-Garcia, Hector M.
AU - McClean, Dougal
AU - Ormiston, John A.
PY - 2012/6
Y1 - 2012/6
N2 - Objectives: This study sought to investigate in vivo the vascular response at the proximal and distal edges of the second-generation ABSORB everolimus-eluting bioresorbable vascular scaffold (BVS). Background: The edge vascular response after implantation of the BVS has not been previously investigated. Methods: The ABSORB Cohort B trial enrolled 101 patients and was divided into B1 (n = 45) and B2 (n = 56) subgroups. The adjacent (5-mm) proximal and distal vessel segments to the implanted ABSORB BVS were investigated at either 6 months (B1) or 1 year (B2) with virtual histology intravascular ultrasound (VH-IVUS) imaging. Results: At the 5-mm proximal edge, the only significant change was modest constrictive remodeling at 6 months (Δ vessel cross-sectional area: -1.80% [-3.18; 1.30], p < 0.05), with a tendency to regress at 1 year (Δ vessel cross-sectional area: -1.53% [-7.74; 2.48], p = 0.06). The relative change of the fibrotic and fibrofatty (FF) tissue areas at this segment were not statistically significant at either time point. At the 5-mm distal edge, a significant increase in the FF tissue of 43.32% [-19.90; 244.28], (p < 0.05) 1-year post-implantation was evident. The changes in dense calcium need to be interpreted with caution since the polymeric struts are detected as "pseudo" dense calcium structures with the VH-IVUS imaging modality. Conclusions: The vascular response up to 1 year after implantation of the ABSORB BVS demonstrated some degree of proximal edge constrictive remodeling and distal edge increase in FF tissue resulting in nonsignificant plaque progression with adaptive expansive remodeling. This morphological and tissue composition behavior appears to not significantly differ from the behavior of metallic drug-eluting stents at the same observational time points.
AB - Objectives: This study sought to investigate in vivo the vascular response at the proximal and distal edges of the second-generation ABSORB everolimus-eluting bioresorbable vascular scaffold (BVS). Background: The edge vascular response after implantation of the BVS has not been previously investigated. Methods: The ABSORB Cohort B trial enrolled 101 patients and was divided into B1 (n = 45) and B2 (n = 56) subgroups. The adjacent (5-mm) proximal and distal vessel segments to the implanted ABSORB BVS were investigated at either 6 months (B1) or 1 year (B2) with virtual histology intravascular ultrasound (VH-IVUS) imaging. Results: At the 5-mm proximal edge, the only significant change was modest constrictive remodeling at 6 months (Δ vessel cross-sectional area: -1.80% [-3.18; 1.30], p < 0.05), with a tendency to regress at 1 year (Δ vessel cross-sectional area: -1.53% [-7.74; 2.48], p = 0.06). The relative change of the fibrotic and fibrofatty (FF) tissue areas at this segment were not statistically significant at either time point. At the 5-mm distal edge, a significant increase in the FF tissue of 43.32% [-19.90; 244.28], (p < 0.05) 1-year post-implantation was evident. The changes in dense calcium need to be interpreted with caution since the polymeric struts are detected as "pseudo" dense calcium structures with the VH-IVUS imaging modality. Conclusions: The vascular response up to 1 year after implantation of the ABSORB BVS demonstrated some degree of proximal edge constrictive remodeling and distal edge increase in FF tissue resulting in nonsignificant plaque progression with adaptive expansive remodeling. This morphological and tissue composition behavior appears to not significantly differ from the behavior of metallic drug-eluting stents at the same observational time points.
KW - ABSORB bioresorbable vascular scaffold
KW - edge vascular response
KW - virtual histology intravascular ultrasound assessment
UR - http://www.scopus.com/inward/record.url?scp=84862904152&partnerID=8YFLogxK
U2 - 10.1016/j.jcin.2012.02.017
DO - 10.1016/j.jcin.2012.02.017
M3 - Article
C2 - 22721662
AN - SCOPUS:84862904152
SN - 1936-8798
VL - 5
SP - 656
EP - 665
JO - JACC: Cardiovascular Interventions
JF - JACC: Cardiovascular Interventions
IS - 6
ER -
