Vascular response of the segments adjacent to the proximal and distal edges of the ABSORB everolimus-eluting bioresorbable vascular scaffold: 6-month and 1-year follow-up assessment: a virtual histology intravascular ultrasound study from the first-in-man ABSORB cohort B trial.
OBJECTIVE
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 B(1) (n = 45) and B(2) (n = 56) subgroups. The adjacent (5-mm) proximal and distal vessel segments to the implanted ABSORB BVS were investigated at either 6 months (B(1)) or 1 year (B(2)) 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.
Thoraxcenter, Erasmus University Medical Center, Rotterdam, the Netherlands.
Bill D
BD
Gogas
Patrick W
PW
Serruys
Roberto
R
Diletti
Vasim
V
Farooq
Salvatore
S
Brugaletta
Maria D
MD
Radu
Jung Ho
JH
Heo
Yoshinobu
Y
Onuma
Robert-Jan M
RJ
van Geuns
Evelyn
E
Regar
Bernard
B
De Bruyne
Bernard
B
Chevalier
Leif
L
Thuesen
Pieter C
PC
Smits
Dariusz
D
Dudek
Jacques
J
Koolen
Stefan
S
Windecker
Robert
R
Whitbourn
Karine
K
Miquel-Hebert
Cecile
C
Dorange
Richard
R
Rapoza
Hector M
HM
Garcia-Garcia
Dougal
D
McClean
John A
JA
Ormiston
D020341:Absorbable Implants; D000368:Aged; D015906:Angioplasty, Balloon, Coronary / Q000009:adverse effects / Q000295:instrumentation*; D002317:Cardiovascular Agents / Q000008:administration & dosage*; D003324:Coronary Artery Disease / Q000628:therapy*; D003331:Coronary Vessels / Q000000981:diagnostic imaging* / Q000473:pathology; D054855:Drug-Eluting Stents; D000068338:Everolimus; D005260:Female; D005355:Fibrosis; D006801:Humans; D008297:Male; D008875:Middle Aged; D011237:Predictive Value of Tests; D011446:Prospective Studies; D011474:Prosthesis Design; D020123:Sirolimus / Q000008:administration & dosage / Q000031:analogs & derivatives*; D013997:Time Factors; D054457:Tissue Scaffolds; D016896:Treatment Outcome; D018084:Ultrasonography, Interventional; D061205:Vascular Calcification / Q000000981:diagnostic imaging
D002317:Cardiovascular Agents; D000068338:Everolimus; D020123:Sirolimus