TY - JOUR
T1 - Two-year clinical, angiographic, and serial optical coherence tomographic follow-up after implantation of an everolimuseluting bioresorbable scaffold and an everolimus-eluting metallic stent
T2 - Insights from the randomised ABSORB Japan trial
AU - Onuma, Yoshinobu
AU - Sotomi, Yohei
AU - Shiomi, Hiroki
AU - Ozaki, Yukio
AU - Namiki, Atsuro
AU - Yasuda, Satoshi
AU - Ueno, Takafumi
AU - Ando, Kenji
AU - Furuya, Jungo
AU - Igarashi, Keiichi
AU - Kozuma, Ken
AU - Tanabe, Kengo
AU - Kusano, Hajime
AU - Rapoza, Richard
AU - Popma, Jeffrey J.
AU - Stone, Gregg W.
AU - Simonton, Charles
AU - Serruys, Patrick W.
AU - Kimura, Takeshi
N1 - Publisher Copyright:
© 2016 Europa Digital & Publishing. All rights reserved.
PY - 2016/10
Y1 - 2016/10
N2 - Aims: 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). Methods and 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 angiography 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.
AB - Aims: 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). Methods and 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 angiography 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.
KW - Everolimus-eluting bioresorbable scaffold
KW - Everolimus-eluting metallic stent
KW - Optical coherence tomography
KW - Randomised trial
UR - http://www.scopus.com/inward/record.url?scp=84994667680&partnerID=8YFLogxK
U2 - 10.4244/EIJY16M09_01
DO - 10.4244/EIJY16M09_01
M3 - Article
C2 - 27597270
AN - SCOPUS:84994667680
SN - 1774-024X
VL - 12
SP - 1090
EP - 1101
JO - EuroIntervention
JF - EuroIntervention
IS - 9
ER -