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).
Publisher DOI
PubMed ID
28893770
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.
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.
Date Issued
2017-09
Publication Type
Article
Subject(s)
Subjects
absorbable implants bifurcation lesion coronary artery disease drug-eluting stents percutaneous coronary intervention
Language(s)
en
Author(s)
Onuma, Yoshinobu | |
Grundeken, Maik J | |
Nakatani, Shimpei | |
Asano, Taku | |
Sotomi, Yohei | |
Foin, Nicolas | |
Ng, Jaryl | |
Okamura, Takayuki | |
Wykrzykowska, Joanna J | |
de Winter, Robbert J | |
van Geuns, Robert-Jan | |
Koolen, Jacques | |
Christiansen, Evald | |
Whitbourn, Robert | |
McClean, Dougal | |
Smits, Pieter | |
Ormiston, John A | |
Serruys, Patrick W |
Additional Credits
Journal
Circulation: Cardiovascular interventions
Publisher
Lippincott Williams & Wilkins
ISSN
1941-7632
Access(Rights)
restricted