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
Yoshinobu Onuma, Yohei Sotomi, Hiroki Shiomi, Yukio Ozaki, Atsuro Namiki, Satoshi Yasuda, Takafumi Ueno, Kenji Ando, Jungo Furuya, Keiichi Igarashi, Ken Kozuma, Kengo Tanabe, Hajime Kusano, Richard Rapoza, Jeffrey J Popma, Gregg W Stone, Charles Simonton, Patrick W Serruys, Takeshi Kimura, Yoshinobu Onuma, Yohei Sotomi, Hiroki Shiomi, Yukio Ozaki, Atsuro Namiki, Satoshi Yasuda, Takafumi Ueno, Kenji Ando, Jungo Furuya, Keiichi Igarashi, Ken Kozuma, Kengo Tanabe, Hajime Kusano, Richard Rapoza, Jeffrey J Popma, Gregg W Stone, Charles Simonton, Patrick W Serruys, Takeshi Kimura
Abstract
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 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.
Source: PubMed