Randomized Comparison Between Everolimus-Eluting Bioresorbable Scaffold and Metallic Stent: Multimodality Imaging Through 3 Years

Yoshinobu Onuma, Yasuhiro Honda, Taku Asano, Hiroki Shiomi, Ken Kozuma, Yukio Ozaki, Atsuo Namiki, Satoshi Yasuda, Takafumi Ueno, Kenji Ando, Jungo Furuya, Keiichi Igarashi Hanaoka, Kengo Tanabe, Kozo Okada, Hideki Kitahara, Masafumi Ono, Hajime Kusano, Richard Rapoza, Charles Simonton, Jeffrey J. PopmaGregg W. Stone, Peter J. Fitzgerald, Patrick W. Serruys, Takeshi Kimura

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Abstract

Objectives: The aim of this study was to investigate the vascular responses and fates of the scaffold after bioresorbable vascular scaffold (BVS) implantation using multimodality imaging. Background: Serial comprehensive image assessments after BVS implantation in the context of a randomized trial have not yet been reported. Methods: In the ABSORB Japan trial, 400 patients were randomized to a BVS (n = 266) or a cobalt-chromium everolimus-eluting stent (n = 134). Through 3 years, patients underwent serial angiography and intravascular ultrasound or optical coherence tomography (OCT). Results: Luminal dimension at 3 years was consistently smaller with the BVS than with the cobalt-chromium everolimus-eluting stent (mean angiographic minimal luminal diameter 2.04 ± 0.63 mm vs. 2.40 ± 0.56 mm, mean difference −0.37 mm [95% confidence interval: −0.50 to −0.24 mm]; p < 0.001), mainly because of smaller device area (6.13 ± 2.03 mm2 vs. 7.15 ± 2.16 mm2, mean difference −1.04 mm2 [95% confidence interval: −1.66 to −0.42 mm2]; p < 0.001), and larger neointimal area (2.10 ± 0.61 mm2 vs. 1.86 ± 0.64 mm2, mean difference 0.24 mm2 [95% confidence interval: 0.06 to 0.43 mm2]; p = 0.01) by OCT. BVS-treated vessels did not show previously reported favorable vessel responses, such as positive vessel remodeling, late luminal enlargement, and restoration of vasomotion, although the OCT-based healing score was on average zero (interquartile range: 0.00 to 0.00). At 3 years, intraluminal scaffold dismantling (ISD) was observed in 14% of BVS. On serial OCT, ISD was observed in 6 lesions at 2 years, where the struts had been fully apposed at post-procedure, while ISD was observed in 12 lesions at 3 years, where 8 lesions were free from ISD on 2-year OCT. In 5 cases of very late scaffold thrombosis, strut discontinuities were detected in all 4 cases with available OCT immediately before reintervention. Conclusions: In this multimodality serial imaging study, luminal dimension at 3 years was smaller with the BVS than with the cobalt-chromium everolimus-eluting stent. ISD, suspected to be one of the mechanisms of very late BVS thrombosis, was observed in a substantial proportion of cases at 3 years, which developed between post-procedure and 2 years and even beyond 2 years. (AVJ-301 Clinical Trial: A Clinical Evaluation of AVJ-301 [Absorb™ BVS] in Japanese Population [ABSORB JAPAN]; NCT01844284)

Original languageEnglish
Pages (from-to)116-127
Number of pages12
JournalJACC: Cardiovascular Interventions
Volume13
Issue number1
DOIs
Publication statusPublished - 13-01-2020

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Stents
Blood Vessels
Optical Coherence Tomography
Chromium
Cobalt
Confidence Intervals
Thrombosis
Everolimus
Angiography
Japan
Clinical Trials
Equipment and Supplies
Population

All Science Journal Classification (ASJC) codes

  • Cardiology and Cardiovascular Medicine

Cite this

Onuma, Yoshinobu ; Honda, Yasuhiro ; Asano, Taku ; Shiomi, Hiroki ; Kozuma, Ken ; Ozaki, Yukio ; Namiki, Atsuo ; Yasuda, Satoshi ; Ueno, Takafumi ; Ando, Kenji ; Furuya, Jungo ; Hanaoka, Keiichi Igarashi ; Tanabe, Kengo ; Okada, Kozo ; Kitahara, Hideki ; Ono, Masafumi ; Kusano, Hajime ; Rapoza, Richard ; Simonton, Charles ; Popma, Jeffrey J. ; Stone, Gregg W. ; Fitzgerald, Peter J. ; Serruys, Patrick W. ; Kimura, Takeshi. / Randomized Comparison Between Everolimus-Eluting Bioresorbable Scaffold and Metallic Stent : Multimodality Imaging Through 3 Years. In: JACC: Cardiovascular Interventions. 2020 ; Vol. 13, No. 1. pp. 116-127.
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abstract = "Objectives: The aim of this study was to investigate the vascular responses and fates of the scaffold after bioresorbable vascular scaffold (BVS) implantation using multimodality imaging. Background: Serial comprehensive image assessments after BVS implantation in the context of a randomized trial have not yet been reported. Methods: In the ABSORB Japan trial, 400 patients were randomized to a BVS (n = 266) or a cobalt-chromium everolimus-eluting stent (n = 134). Through 3 years, patients underwent serial angiography and intravascular ultrasound or optical coherence tomography (OCT). Results: Luminal dimension at 3 years was consistently smaller with the BVS than with the cobalt-chromium everolimus-eluting stent (mean angiographic minimal luminal diameter 2.04 ± 0.63 mm vs. 2.40 ± 0.56 mm, mean difference −0.37 mm [95{\%} confidence interval: −0.50 to −0.24 mm]; p < 0.001), mainly because of smaller device area (6.13 ± 2.03 mm2 vs. 7.15 ± 2.16 mm2, mean difference −1.04 mm2 [95{\%} confidence interval: −1.66 to −0.42 mm2]; p < 0.001), and larger neointimal area (2.10 ± 0.61 mm2 vs. 1.86 ± 0.64 mm2, mean difference 0.24 mm2 [95{\%} confidence interval: 0.06 to 0.43 mm2]; p = 0.01) by OCT. BVS-treated vessels did not show previously reported favorable vessel responses, such as positive vessel remodeling, late luminal enlargement, and restoration of vasomotion, although the OCT-based healing score was on average zero (interquartile range: 0.00 to 0.00). At 3 years, intraluminal scaffold dismantling (ISD) was observed in 14{\%} of BVS. On serial OCT, ISD was observed in 6 lesions at 2 years, where the struts had been fully apposed at post-procedure, while ISD was observed in 12 lesions at 3 years, where 8 lesions were free from ISD on 2-year OCT. In 5 cases of very late scaffold thrombosis, strut discontinuities were detected in all 4 cases with available OCT immediately before reintervention. Conclusions: In this multimodality serial imaging study, luminal dimension at 3 years was smaller with the BVS than with the cobalt-chromium everolimus-eluting stent. ISD, suspected to be one of the mechanisms of very late BVS thrombosis, was observed in a substantial proportion of cases at 3 years, which developed between post-procedure and 2 years and even beyond 2 years. (AVJ-301 Clinical Trial: A Clinical Evaluation of AVJ-301 [Absorb™ BVS] in Japanese Population [ABSORB JAPAN]; NCT01844284)",
author = "Yoshinobu Onuma and Yasuhiro Honda and Taku Asano and Hiroki Shiomi and Ken Kozuma and Yukio Ozaki and Atsuo Namiki and Satoshi Yasuda and Takafumi Ueno and Kenji Ando and Jungo Furuya and Hanaoka, {Keiichi Igarashi} and Kengo Tanabe and Kozo Okada and Hideki Kitahara and Masafumi Ono and Hajime Kusano and Richard Rapoza and Charles Simonton and Popma, {Jeffrey J.} and Stone, {Gregg W.} and Fitzgerald, {Peter J.} and Serruys, {Patrick W.} and Takeshi Kimura",
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month = "1",
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language = "English",
volume = "13",
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Onuma, Y, Honda, Y, Asano, T, Shiomi, H, Kozuma, K, Ozaki, Y, Namiki, A, Yasuda, S, Ueno, T, Ando, K, Furuya, J, Hanaoka, KI, Tanabe, K, Okada, K, Kitahara, H, Ono, M, Kusano, H, Rapoza, R, Simonton, C, Popma, JJ, Stone, GW, Fitzgerald, PJ, Serruys, PW & Kimura, T 2020, 'Randomized Comparison Between Everolimus-Eluting Bioresorbable Scaffold and Metallic Stent: Multimodality Imaging Through 3 Years', JACC: Cardiovascular Interventions, vol. 13, no. 1, pp. 116-127. https://doi.org/10.1016/j.jcin.2019.09.047

Randomized Comparison Between Everolimus-Eluting Bioresorbable Scaffold and Metallic Stent : Multimodality Imaging Through 3 Years. / Onuma, Yoshinobu; Honda, Yasuhiro; Asano, Taku; Shiomi, Hiroki; Kozuma, Ken; Ozaki, Yukio; Namiki, Atsuo; Yasuda, Satoshi; Ueno, Takafumi; Ando, Kenji; Furuya, Jungo; Hanaoka, Keiichi Igarashi; Tanabe, Kengo; Okada, Kozo; Kitahara, Hideki; Ono, Masafumi; Kusano, Hajime; Rapoza, Richard; Simonton, Charles; Popma, Jeffrey J.; Stone, Gregg W.; Fitzgerald, Peter J.; Serruys, Patrick W.; Kimura, Takeshi.

In: JACC: Cardiovascular Interventions, Vol. 13, No. 1, 13.01.2020, p. 116-127.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Randomized Comparison Between Everolimus-Eluting Bioresorbable Scaffold and Metallic Stent

T2 - Multimodality Imaging Through 3 Years

AU - Onuma, Yoshinobu

AU - Honda, Yasuhiro

AU - Asano, Taku

AU - Shiomi, Hiroki

AU - Kozuma, Ken

AU - Ozaki, Yukio

AU - Namiki, Atsuo

AU - Yasuda, Satoshi

AU - Ueno, Takafumi

AU - Ando, Kenji

AU - Furuya, Jungo

AU - Hanaoka, Keiichi Igarashi

AU - Tanabe, Kengo

AU - Okada, Kozo

AU - Kitahara, Hideki

AU - Ono, Masafumi

AU - Kusano, Hajime

AU - Rapoza, Richard

AU - Simonton, Charles

AU - Popma, Jeffrey J.

AU - Stone, Gregg W.

AU - Fitzgerald, Peter J.

AU - Serruys, Patrick W.

AU - Kimura, Takeshi

PY - 2020/1/13

Y1 - 2020/1/13

N2 - Objectives: The aim of this study was to investigate the vascular responses and fates of the scaffold after bioresorbable vascular scaffold (BVS) implantation using multimodality imaging. Background: Serial comprehensive image assessments after BVS implantation in the context of a randomized trial have not yet been reported. Methods: In the ABSORB Japan trial, 400 patients were randomized to a BVS (n = 266) or a cobalt-chromium everolimus-eluting stent (n = 134). Through 3 years, patients underwent serial angiography and intravascular ultrasound or optical coherence tomography (OCT). Results: Luminal dimension at 3 years was consistently smaller with the BVS than with the cobalt-chromium everolimus-eluting stent (mean angiographic minimal luminal diameter 2.04 ± 0.63 mm vs. 2.40 ± 0.56 mm, mean difference −0.37 mm [95% confidence interval: −0.50 to −0.24 mm]; p < 0.001), mainly because of smaller device area (6.13 ± 2.03 mm2 vs. 7.15 ± 2.16 mm2, mean difference −1.04 mm2 [95% confidence interval: −1.66 to −0.42 mm2]; p < 0.001), and larger neointimal area (2.10 ± 0.61 mm2 vs. 1.86 ± 0.64 mm2, mean difference 0.24 mm2 [95% confidence interval: 0.06 to 0.43 mm2]; p = 0.01) by OCT. BVS-treated vessels did not show previously reported favorable vessel responses, such as positive vessel remodeling, late luminal enlargement, and restoration of vasomotion, although the OCT-based healing score was on average zero (interquartile range: 0.00 to 0.00). At 3 years, intraluminal scaffold dismantling (ISD) was observed in 14% of BVS. On serial OCT, ISD was observed in 6 lesions at 2 years, where the struts had been fully apposed at post-procedure, while ISD was observed in 12 lesions at 3 years, where 8 lesions were free from ISD on 2-year OCT. In 5 cases of very late scaffold thrombosis, strut discontinuities were detected in all 4 cases with available OCT immediately before reintervention. Conclusions: In this multimodality serial imaging study, luminal dimension at 3 years was smaller with the BVS than with the cobalt-chromium everolimus-eluting stent. ISD, suspected to be one of the mechanisms of very late BVS thrombosis, was observed in a substantial proportion of cases at 3 years, which developed between post-procedure and 2 years and even beyond 2 years. (AVJ-301 Clinical Trial: A Clinical Evaluation of AVJ-301 [Absorb™ BVS] in Japanese Population [ABSORB JAPAN]; NCT01844284)

AB - Objectives: The aim of this study was to investigate the vascular responses and fates of the scaffold after bioresorbable vascular scaffold (BVS) implantation using multimodality imaging. Background: Serial comprehensive image assessments after BVS implantation in the context of a randomized trial have not yet been reported. Methods: In the ABSORB Japan trial, 400 patients were randomized to a BVS (n = 266) or a cobalt-chromium everolimus-eluting stent (n = 134). Through 3 years, patients underwent serial angiography and intravascular ultrasound or optical coherence tomography (OCT). Results: Luminal dimension at 3 years was consistently smaller with the BVS than with the cobalt-chromium everolimus-eluting stent (mean angiographic minimal luminal diameter 2.04 ± 0.63 mm vs. 2.40 ± 0.56 mm, mean difference −0.37 mm [95% confidence interval: −0.50 to −0.24 mm]; p < 0.001), mainly because of smaller device area (6.13 ± 2.03 mm2 vs. 7.15 ± 2.16 mm2, mean difference −1.04 mm2 [95% confidence interval: −1.66 to −0.42 mm2]; p < 0.001), and larger neointimal area (2.10 ± 0.61 mm2 vs. 1.86 ± 0.64 mm2, mean difference 0.24 mm2 [95% confidence interval: 0.06 to 0.43 mm2]; p = 0.01) by OCT. BVS-treated vessels did not show previously reported favorable vessel responses, such as positive vessel remodeling, late luminal enlargement, and restoration of vasomotion, although the OCT-based healing score was on average zero (interquartile range: 0.00 to 0.00). At 3 years, intraluminal scaffold dismantling (ISD) was observed in 14% of BVS. On serial OCT, ISD was observed in 6 lesions at 2 years, where the struts had been fully apposed at post-procedure, while ISD was observed in 12 lesions at 3 years, where 8 lesions were free from ISD on 2-year OCT. In 5 cases of very late scaffold thrombosis, strut discontinuities were detected in all 4 cases with available OCT immediately before reintervention. Conclusions: In this multimodality serial imaging study, luminal dimension at 3 years was smaller with the BVS than with the cobalt-chromium everolimus-eluting stent. ISD, suspected to be one of the mechanisms of very late BVS thrombosis, was observed in a substantial proportion of cases at 3 years, which developed between post-procedure and 2 years and even beyond 2 years. (AVJ-301 Clinical Trial: A Clinical Evaluation of AVJ-301 [Absorb™ BVS] in Japanese Population [ABSORB JAPAN]; NCT01844284)

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