Serial 5-Year Evaluation of Side Branches Jailed by Bioresorbable Vascular Scaffolds Using 3-Dimensional Optical Coherence Tomography: Insights From the ABSORB Cohort B Trial (A Clinical Evaluation of the Bioabsorbable Everolimus Eluting Coronary Stent System in the Treatment of Patients With De Novo Native Coronary Artery Lesions)

Yoshinobu Onuma; Maik J Grundeken; Shimpei Nakatani; Taku Asano; Yohei Sotomi; Nicolas Foin; Jaryl Ng; Takayuki Okamura; Joanna J Wykrzykowska; Robbert J de Winter; Robert-Jan van Geuns; Jacques Koolen; Evald H Christiansen; Robert Whitbourn; Dougal McClean; Pieter Smits; Stephan Windecker; John A Ormiston; Patrick W Serruys

doi:10.1161/CIRCINTERVENTIONS.116.004393

Serial 5-Year Evaluation of Side Branches Jailed by Bioresorbable Vascular Scaffolds Using 3-Dimensional Optical Coherence Tomography: Insights From the ABSORB Cohort B Trial (A Clinical Evaluation of the Bioabsorbable Everolimus Eluting Coronary Stent System in the Treatment of Patients With De Novo Native Coronary Artery Lesions)

Yoshinobu Onuma
, Maik J Grundeken
, Shimpei Nakatani
, Taku Asano
, Yohei Sotomi
, Nicolas Foin
, Jaryl Ng
, Takayuki Okamura
, Joanna J Wykrzykowska
, Robbert J de Winter
, Robert-Jan van Geuns
, Jacques Koolen
, Evald H Christiansen
, Robert Whitbourn
, Dougal McClean
, Pieter Smits
, Stephan Windecker
, John A Ormiston
, Patrick W Serruys

University of Amsterdam
From the Thoraxcenter
Erasmus MC
Rotterdam
the Netherlands (Y.O.
R.-J.v.G.)
Cardialysis BV
the Netherlands (Y.O.)
Academic Medical Center
Erasmus University Rotterdam
Cardialysis BV, Netherlands
National Heart Centre Singapore
National University of Singapore
Yamaguchi University
Catharina Hospital
Aarhus University
St. Vincent's Hospital Melbourne
Christchurch Hospital New Zealand
Division of Cardiology, Rotterdam, Netherlands
University of Bern
Auckland City Hospital
International Center for Circulatory Health NHLI, 3000 Rotterdam, Netherlands

Research output: Contribution to journal › Article › Academic › peer-review

Abstract

BACKGROUND: The long-term fate of Absorb bioresorbable vascular scaffold (Abbott Vascular, Santa Clara, CA) struts jailing side branch ostia has not been clarified. We therefore evaluate serially (post-procedure and at 6 months, 1, 2, 3, and 5 years) the appearance and fate of jailed Absorb bioresorbable vascular scaffold struts.

METHODS AND RESULTS: We performed 3-dimensional optical coherence tomographic analysis of the ABSORB Cohort B trial (A Clinical Evaluation of the Bioabsorbable Everolimus Eluting Coronary Stent System in the Treatment of Patients With De Novo Native Coronary Artery Lesions) up to 5 years using a novel, validated cut-plane analysis method. We included 29 patients with a total of 85 side branch ostia. From the 12 ostia which could be assessed in true serial fashion, 7 showed a pattern of initial decrease in the ostial area free from struts, followed by an increase in strut-free ostial area toward the end of the 5 years of follow-up. In a repeated-measures analysis with time as fixed variable and ostial area free from struts as dependent variable, we showed a numeric decrease in the estimated ostial area free from struts from 0.75 mm2 (baseline) to 0.68 mm2 (first follow-up visit at 6 months or 1 year) and 0.63 mm2 (second follow-up visit at 2 or 3 years). However, from the second visit to the 5-year follow-up visit, there was a statistically significant increase from 0.63 to 0.89 mm2 (P=0.001). Struts overlying an ostium divided the ostium into compartments, and the number of these compartments decreased over time.

CONCLUSIONS: This study showed that in most cases, the side branch ostial area free from struts initially decreased. However, with full scaffold bioresorption, the ostial area free from scaffold increased between 2 to 3 years and 5 years in the vast majority of patients.

CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT00856856.

Original language	English
Article number	e004393
Journal	Circulation. Cardiovascular interventions
Volume	10
Issue number	9
Early online date	2017
DOIs	https://doi.org/10.1161/CIRCINTERVENTIONS.116.004393
Publication status	Published - Sept 2017

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

SDG 3 Good Health and Well-being

Keywords

Absorbable Implants
Cardiovascular Agents/administration & dosage
Coronary Artery Disease/diagnostic imaging
Coronary Vessels/diagnostic imaging
Drug-Eluting Stents
Everolimus/administration & dosage
Humans
Percutaneous Coronary Intervention/adverse effects
Predictive Value of Tests
Prosthesis Design
Reproducibility of Results
Time Factors
Tomography, Optical Coherence
Treatment Outcome

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Onuma, Y., Grundeken, M. J., Nakatani, S., Asano, T., Sotomi, Y., Foin, N., Ng, J., Okamura, T., Wykrzykowska, J. J., de Winter, R. J., van Geuns, R.-J., Koolen, J., Christiansen, E. H., Whitbourn, R., McClean, D., Smits, P., Windecker, S., Ormiston, J. A., & Serruys, P. W. (2017). Serial 5-Year Evaluation of Side Branches Jailed by Bioresorbable Vascular Scaffolds Using 3-Dimensional Optical Coherence Tomography: Insights From the ABSORB Cohort B Trial (A Clinical Evaluation of the Bioabsorbable Everolimus Eluting Coronary Stent System in the Treatment of Patients With De Novo Native Coronary Artery Lesions). Circulation. Cardiovascular interventions, 10(9), Article e004393. https://doi.org/10.1161/CIRCINTERVENTIONS.116.004393

Onuma, Yoshinobu ; Grundeken, Maik J ; Nakatani, Shimpei et al. / Serial 5-Year Evaluation of Side Branches Jailed by Bioresorbable Vascular Scaffolds Using 3-Dimensional Optical Coherence Tomography : Insights From the ABSORB Cohort B Trial (A Clinical Evaluation of the Bioabsorbable Everolimus Eluting Coronary Stent System in the Treatment of Patients With De Novo Native Coronary Artery Lesions). In: Circulation. Cardiovascular interventions. 2017 ; Vol. 10, No. 9.

@article{f55a93ca966d463ba60e291feaa3e863,

title = "Serial 5-Year Evaluation of Side Branches Jailed by Bioresorbable Vascular Scaffolds Using 3-Dimensional Optical Coherence Tomography: Insights From the ABSORB Cohort B Trial (A Clinical Evaluation of the Bioabsorbable Everolimus Eluting Coronary Stent System in the Treatment of Patients With De Novo Native Coronary Artery Lesions)",

abstract = "BACKGROUND: The long-term fate of Absorb bioresorbable vascular scaffold (Abbott Vascular, Santa Clara, CA) struts jailing side branch ostia has not been clarified. We therefore evaluate serially (post-procedure and at 6 months, 1, 2, 3, and 5 years) the appearance and fate of jailed Absorb bioresorbable vascular scaffold struts.METHODS AND RESULTS: We performed 3-dimensional optical coherence tomographic analysis of the ABSORB Cohort B trial (A Clinical Evaluation of the Bioabsorbable Everolimus Eluting Coronary Stent System in the Treatment of Patients With De Novo Native Coronary Artery Lesions) up to 5 years using a novel, validated cut-plane analysis method. We included 29 patients with a total of 85 side branch ostia. From the 12 ostia which could be assessed in true serial fashion, 7 showed a pattern of initial decrease in the ostial area free from struts, followed by an increase in strut-free ostial area toward the end of the 5 years of follow-up. In a repeated-measures analysis with time as fixed variable and ostial area free from struts as dependent variable, we showed a numeric decrease in the estimated ostial area free from struts from 0.75 mm2 (baseline) to 0.68 mm2 (first follow-up visit at 6 months or 1 year) and 0.63 mm2 (second follow-up visit at 2 or 3 years). However, from the second visit to the 5-year follow-up visit, there was a statistically significant increase from 0.63 to 0.89 mm2 (P=0.001). Struts overlying an ostium divided the ostium into compartments, and the number of these compartments decreased over time.CONCLUSIONS: This study showed that in most cases, the side branch ostial area free from struts initially decreased. However, with full scaffold bioresorption, the ostial area free from scaffold increased between 2 to 3 years and 5 years in the vast majority of patients.CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT00856856.",

keywords = "Absorbable Implants, Cardiovascular Agents/administration \& dosage, Coronary Artery Disease/diagnostic imaging, Coronary Vessels/diagnostic imaging, Drug-Eluting Stents, Everolimus/administration \& dosage, Humans, Percutaneous Coronary Intervention/adverse effects, Predictive Value of Tests, Prosthesis Design, Reproducibility of Results, Time Factors, Tomography, Optical Coherence, Treatment Outcome",

author = "Yoshinobu Onuma and Grundeken, \{Maik J\} and Shimpei Nakatani and Taku Asano and Yohei Sotomi and Nicolas Foin and Jaryl Ng and Takayuki Okamura and Wykrzykowska, \{Joanna J\} and \{de Winter\}, \{Robbert J\} and \{van Geuns\}, Robert-Jan and Jacques Koolen and Christiansen, \{Evald H\} and Robert Whitbourn and Dougal McClean and Pieter Smits and Stephan Windecker and Ormiston, \{John A\} and Serruys, \{Patrick W\}",

note = "{\textcopyright} 2017 American Heart Association, Inc.",

year = "2017",

month = sep,

doi = "10.1161/CIRCINTERVENTIONS.116.004393",

language = "English",

volume = "10",

journal = "Circulation. Cardiovascular interventions",

issn = "1941-7640",

publisher = "Lippincott Williams and Wilkins",

number = "9",

}

Onuma, Y, Grundeken, MJ, Nakatani, S, Asano, T, Sotomi, Y, Foin, N, Ng, J, Okamura, T, Wykrzykowska, JJ, de Winter, RJ, van Geuns, R-J, Koolen, J, Christiansen, EH, Whitbourn, R, McClean, D, Smits, P, Windecker, S, Ormiston, JA & Serruys, PW 2017, 'Serial 5-Year Evaluation of Side Branches Jailed by Bioresorbable Vascular Scaffolds Using 3-Dimensional Optical Coherence Tomography: Insights From the ABSORB Cohort B Trial (A Clinical Evaluation of the Bioabsorbable Everolimus Eluting Coronary Stent System in the Treatment of Patients With De Novo Native Coronary Artery Lesions)', Circulation. Cardiovascular interventions, vol. 10, no. 9, e004393. https://doi.org/10.1161/CIRCINTERVENTIONS.116.004393

Serial 5-Year Evaluation of Side Branches Jailed by Bioresorbable Vascular Scaffolds Using 3-Dimensional Optical Coherence Tomography: Insights From the ABSORB Cohort B Trial (A Clinical Evaluation of the Bioabsorbable Everolimus Eluting Coronary Stent System in the Treatment of Patients With De Novo Native Coronary Artery Lesions). / Onuma, Yoshinobu; Grundeken, Maik J; Nakatani, Shimpei et al.
In: Circulation. Cardiovascular interventions, Vol. 10, No. 9, e004393, 09.2017.

Research output: Contribution to journal › Article › Academic › peer-review

TY - JOUR

T1 - Serial 5-Year Evaluation of Side Branches Jailed by Bioresorbable Vascular Scaffolds Using 3-Dimensional Optical Coherence Tomography

T2 - Insights From the ABSORB Cohort B Trial (A Clinical Evaluation of the Bioabsorbable Everolimus Eluting Coronary Stent System in the Treatment of Patients With De Novo Native Coronary Artery Lesions)

AU - Onuma, Yoshinobu

AU - Grundeken, Maik J

AU - Nakatani, Shimpei

AU - Asano, Taku

AU - Sotomi, Yohei

AU - Foin, Nicolas

AU - Ng, Jaryl

AU - Okamura, Takayuki

AU - Wykrzykowska, Joanna J

AU - de Winter, Robbert J

AU - van Geuns, Robert-Jan

AU - Koolen, Jacques

AU - Christiansen, Evald H

AU - Whitbourn, Robert

AU - McClean, Dougal

AU - Smits, Pieter

AU - Windecker, Stephan

AU - Ormiston, John A

AU - Serruys, Patrick W

PY - 2017/9

Y1 - 2017/9

N2 - BACKGROUND: The long-term fate of Absorb bioresorbable vascular scaffold (Abbott Vascular, Santa Clara, CA) struts jailing side branch ostia has not been clarified. We therefore evaluate serially (post-procedure and at 6 months, 1, 2, 3, and 5 years) the appearance and fate of jailed Absorb bioresorbable vascular scaffold struts.METHODS AND RESULTS: We performed 3-dimensional optical coherence tomographic analysis of the ABSORB Cohort B trial (A Clinical Evaluation of the Bioabsorbable Everolimus Eluting Coronary Stent System in the Treatment of Patients With De Novo Native Coronary Artery Lesions) up to 5 years using a novel, validated cut-plane analysis method. We included 29 patients with a total of 85 side branch ostia. From the 12 ostia which could be assessed in true serial fashion, 7 showed a pattern of initial decrease in the ostial area free from struts, followed by an increase in strut-free ostial area toward the end of the 5 years of follow-up. In a repeated-measures analysis with time as fixed variable and ostial area free from struts as dependent variable, we showed a numeric decrease in the estimated ostial area free from struts from 0.75 mm2 (baseline) to 0.68 mm2 (first follow-up visit at 6 months or 1 year) and 0.63 mm2 (second follow-up visit at 2 or 3 years). However, from the second visit to the 5-year follow-up visit, there was a statistically significant increase from 0.63 to 0.89 mm2 (P=0.001). Struts overlying an ostium divided the ostium into compartments, and the number of these compartments decreased over time.CONCLUSIONS: This study showed that in most cases, the side branch ostial area free from struts initially decreased. However, with full scaffold bioresorption, the ostial area free from scaffold increased between 2 to 3 years and 5 years in the vast majority of patients.CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT00856856.

AB - BACKGROUND: The long-term fate of Absorb bioresorbable vascular scaffold (Abbott Vascular, Santa Clara, CA) struts jailing side branch ostia has not been clarified. We therefore evaluate serially (post-procedure and at 6 months, 1, 2, 3, and 5 years) the appearance and fate of jailed Absorb bioresorbable vascular scaffold struts.METHODS AND RESULTS: We performed 3-dimensional optical coherence tomographic analysis of the ABSORB Cohort B trial (A Clinical Evaluation of the Bioabsorbable Everolimus Eluting Coronary Stent System in the Treatment of Patients With De Novo Native Coronary Artery Lesions) up to 5 years using a novel, validated cut-plane analysis method. We included 29 patients with a total of 85 side branch ostia. From the 12 ostia which could be assessed in true serial fashion, 7 showed a pattern of initial decrease in the ostial area free from struts, followed by an increase in strut-free ostial area toward the end of the 5 years of follow-up. In a repeated-measures analysis with time as fixed variable and ostial area free from struts as dependent variable, we showed a numeric decrease in the estimated ostial area free from struts from 0.75 mm2 (baseline) to 0.68 mm2 (first follow-up visit at 6 months or 1 year) and 0.63 mm2 (second follow-up visit at 2 or 3 years). However, from the second visit to the 5-year follow-up visit, there was a statistically significant increase from 0.63 to 0.89 mm2 (P=0.001). Struts overlying an ostium divided the ostium into compartments, and the number of these compartments decreased over time.CONCLUSIONS: This study showed that in most cases, the side branch ostial area free from struts initially decreased. However, with full scaffold bioresorption, the ostial area free from scaffold increased between 2 to 3 years and 5 years in the vast majority of patients.CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT00856856.

KW - Absorbable Implants

KW - Cardiovascular Agents/administration & dosage

KW - Coronary Artery Disease/diagnostic imaging

KW - Coronary Vessels/diagnostic imaging

KW - Drug-Eluting Stents

KW - Everolimus/administration & dosage

KW - Humans

KW - Percutaneous Coronary Intervention/adverse effects

KW - Predictive Value of Tests

KW - Prosthesis Design

KW - Reproducibility of Results

KW - Time Factors

KW - Tomography, Optical Coherence

KW - Treatment Outcome

UR - https://www.scopus.com/pages/publications/85031039392

UR - https://www.ncbi.nlm.nih.gov/pubmed/28893770

U2 - 10.1161/CIRCINTERVENTIONS.116.004393

DO - 10.1161/CIRCINTERVENTIONS.116.004393

M3 - Article

C2 - 28893770

SN - 1941-7640

VL - 10

JO - Circulation. Cardiovascular interventions

JF - Circulation. Cardiovascular interventions

IS - 9

M1 - e004393

ER -