Two-year clinical, angiographic, and serial optical coherence tomographic follow-up after implantation of an everolimuseluting 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

Research output: Contribution to journalArticle

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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 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.

Original languageEnglish
Pages (from-to)1090-1101
Number of pages12
JournalEuroIntervention
Volume12
Issue number9
DOIs
Publication statusPublished - 01-10-2016

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Stents
Blood Vessels
Japan
Chromium
Cobalt
Optical Coherence Tomography
Thrombosis
Everolimus
Equipment and Supplies
Angiography
Tomography
Growth

All Science Journal Classification (ASJC) codes

  • Cardiology and Cardiovascular Medicine

Cite this

Onuma, Yoshinobu ; Sotomi, Yohei ; Shiomi, Hiroki ; Ozaki, Yukio ; Namiki, Atsuro ; Yasuda, Satoshi ; Ueno, Takafumi ; Ando, Kenji ; Furuya, Jungo ; Igarashi, Keiichi ; Kozuma, Ken ; Tanabe, Kengo ; Kusano, Hajime ; Rapoza, Richard ; Popma, Jeffrey J. ; Stone, Gregg W. ; Simonton, Charles ; Serruys, Patrick W. ; Kimura, Takeshi. / Two-year clinical, angiographic, and serial optical coherence tomographic follow-up after implantation of an everolimuseluting bioresorbable scaffold and an everolimus-eluting metallic stent : Insights from the randomised ABSORB Japan trial. In: EuroIntervention. 2016 ; Vol. 12, No. 9. pp. 1090-1101.
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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 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.",
author = "Yoshinobu Onuma and Yohei Sotomi and Hiroki Shiomi and Yukio Ozaki and Atsuro Namiki and Satoshi Yasuda and Takafumi Ueno and Kenji Ando and Jungo Furuya and Keiichi Igarashi and Ken Kozuma and Kengo Tanabe and Hajime Kusano and Richard Rapoza and Popma, {Jeffrey J.} and Stone, {Gregg W.} and Charles Simonton and Serruys, {Patrick W.} and Takeshi Kimura",
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Onuma, Y, Sotomi, Y, Shiomi, H, Ozaki, Y, Namiki, A, Yasuda, S, Ueno, T, Ando, K, Furuya, J, Igarashi, K, Kozuma, K, Tanabe, K, Kusano, H, Rapoza, R, Popma, JJ, Stone, GW, Simonton, C, Serruys, PW & Kimura, T 2016, 'Two-year clinical, angiographic, and serial optical coherence tomographic follow-up after implantation of an everolimuseluting bioresorbable scaffold and an everolimus-eluting metallic stent: Insights from the randomised ABSORB Japan trial', EuroIntervention, vol. 12, no. 9, pp. 1090-1101. https://doi.org/10.4244/EIJY16M09_01

Two-year clinical, angiographic, and serial optical coherence tomographic follow-up after implantation of an everolimuseluting bioresorbable scaffold and an everolimus-eluting metallic stent : Insights from the randomised ABSORB Japan trial. / Onuma, Yoshinobu; Sotomi, Yohei; Shiomi, Hiroki; Ozaki, Yukio; Namiki, Atsuro; Yasuda, Satoshi; Ueno, Takafumi; Ando, Kenji; Furuya, Jungo; Igarashi, Keiichi; Kozuma, Ken; Tanabe, Kengo; Kusano, Hajime; Rapoza, Richard; Popma, Jeffrey J.; Stone, Gregg W.; Simonton, Charles; Serruys, Patrick W.; Kimura, Takeshi.

In: EuroIntervention, Vol. 12, No. 9, 01.10.2016, p. 1090-1101.

Research output: Contribution to journalArticle

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

PY - 2016/10/1

Y1 - 2016/10/1

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.

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