Two-year clinical, angiographic, and serial optical coherence tomographic follow-up after implantation of an everolimus-eluting bioresorbable scaffold and an everolimus-eluting metallic stent: insights from the randomised ABSORB Japan trial.
OBJECTIVE
We sought to investigate two-year clinical and serial optical coherence tomography (OCT) outcomes after implantation of a fully bioresorbable vascular scaffold (BVS) or a cobalt-chromium everolimus-eluting stent (CoCr-EES).


RESULTS
In the ABSORB Japan trial, 400 patients were randomised in a 2:1 ratio to BVS (N=266) or CoCr-EES (N=134). A pre-specified OCT subgroup (N=125, OCT-1 group) underwent angio-graphy and OCT post procedure and at two years. Overall, the two-year TLF rates were 7.3% and 3.8% in the BVS and CoCr-EES arms (p=0.18), respectively. Very late scaffold thrombosis (VLST) beyond one year was observed in 1.6% (four cases: all in non-OCT-1 subgroups) of the BVS arm, while there was no VLST in the CoCr-EES arm. In three cases, OCT at the time of or shortly after VLST demonstrated strut discontinuities, malapposition and/or uncovered struts. However, the vessel healing by two-year OCT was nearly complete in both BVS and CoCr-EES arms with almost fully covered struts, and minimal malapposition. The flow area by two-year OCT was smaller in the BVS arm than in the CoCr-EES arm, mainly due to tissue growth inside the device. However, there were no differences between the BVS and CoCr-EES with regard to the quality of homogenous tissues growing inside the devices.


CONCLUSIONS
The rate of TLF was numerically higher in the BVS arm than in the CoCr-EES arm, although this difference was not statistically significant. VLST was observed only in the BVS arm at a rate of 1.6% between one and two years. Further studies are mandatory to investigate the risk of BVS relative to metallic stents for VLST, and the underlying mechanisms of BVS VLST.
Thoraxcenter, Erasmus MC, Rotterdam, The Netherlands.
Yoshinobu
Y
Onuma
Yohei
Y
Sotomi
Hiroki
H
Shiomi
Yukio
Y
Ozaki
Atsuro
A
Namiki
Satoshi
S
Yasuda
Takafumi
T
Ueno
Kenji
K
Ando
Jungo
J
Furuya
Keiichi
K
Igarashi
Ken
K
Kozuma
Kengo
K
Tanabe
Hajime
H
Kusano
Richard
R
Rapoza
Jeffrey J
JJ
Popma
Gregg W
GW
Stone
Charles
C
Simonton
Patrick W
PW
Serruys
Takeshi
T
Kimura
D020341:Absorbable Implants; D000368:Aged; D000970:Antineoplastic Agents / Q000008:administration & dosage*; D002318:Cardiovascular Diseases / Q000401:mortality; D017023:Coronary Angiography; D003324:Coronary Artery Disease / Q000000981:diagnostic imaging / Q000601:surgery*; D054855:Drug-Eluting Stents; D000068338:Everolimus / Q000008:administration & dosage*; D005260:Female; D005500:Follow-Up Studies; D006083:Graft Occlusion, Vascular / Q000453:epidemiology; D006801:Humans; D007564:Japan; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000453:epidemiology; D009204:Myocardial Revascularization / Q000706:statistics & numerical data; D062645:Percutaneous Coronary Intervention; D011183:Postoperative Complications / Q000453:epidemiology; D016037:Single-Blind Method; D013927:Thrombosis / Q000453:epidemiology; D054457:Tissue Scaffolds; D041623:Tomography, Optical Coherence; D016896:Treatment Outcome
D000970:Antineoplastic Agents; D000068338:Everolimus