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Two year efficacy and safety of small versus large ABSORB bioresorbable vascular scaffolds of ≤18 mm device length: A subgroup analysis of the German-Austrian ABSORB RegIstRy (GABI-R)

AIMS: The ABSORB bioresorbable vascular scaffold raised safety concerns due to higher rates of scaffold thrombosis (ScT) and adequate scaffold diameter and length for scaffold technology. Smaller scaffold diameter (SScD, 2.5 mm) was an infrequently quoted predictor of major adverse cardiac events (M...

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Autores principales: Zaczkiewicz, Myron, Wein, Bastian, Graf, Matthias, Zimmermann, Oliver, Kastner, Johannes, Wöhrle, Jochen, Thomas, Riemer, Hamm, Christian, Torzewski, Jan
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Elsevier 2020
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7096743/
https://www.ncbi.nlm.nih.gov/pubmed/32258361
http://dx.doi.org/10.1016/j.ijcha.2020.100501
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author Zaczkiewicz, Myron
Wein, Bastian
Graf, Matthias
Zimmermann, Oliver
Kastner, Johannes
Wöhrle, Jochen
Thomas, Riemer
Hamm, Christian
Torzewski, Jan
author_facet Zaczkiewicz, Myron
Wein, Bastian
Graf, Matthias
Zimmermann, Oliver
Kastner, Johannes
Wöhrle, Jochen
Thomas, Riemer
Hamm, Christian
Torzewski, Jan
author_sort Zaczkiewicz, Myron
collection PubMed
description AIMS: The ABSORB bioresorbable vascular scaffold raised safety concerns due to higher rates of scaffold thrombosis (ScT) and adequate scaffold diameter and length for scaffold technology. Smaller scaffold diameter (SScD, 2.5 mm) was an infrequently quoted predictor of major adverse cardiac events (MACE). Therefore, we evaluated the impact of SScD compared to large scaffold diameter (LScD, ≥3 mm) of ≤18 mm device length on 2 year outcome in the all-comer real life GABI-R cohort. METHODS AND RESULTS: We compared patients with implanted LScD (1341 patients) vs. SScD (444 patients) of ≤18 mm device length. Patients with LScD more often presented with ST-elevation myocardial infarction (35.8% vs. 20.6%, p < 0.0001) and single-vessel disease (50.6% vs. 36.5% p < 0.0001). After a 24 months follow-up, there was no difference in regard of MACE (9.66% vs. 12.31%, p = 0.14) or definite/probable ST (2.47% vs. 2.82%, p = 0.71). Despite no difference in target lesion revascularisations (TLR) (5.81% vs. 7.71%, p = 0.18), there was a higher need for target vessel revascularisation (TVR) in the SScD-group (11.57% vs. 7.51%, p < 0.05). CONCLUSION: Compared to LScD, SScD of ≤18 mm device length demonstrated comparable safety in regard to MACE and ScT as well as efficacy in regard to TLR. Resorbable scaffold technology should not be restricted to large vessel diameters. CLINICAL TRIAL REGISTRATION: https://clinicaltrials.gov/ct2/show/NCT02066623.
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spelling pubmed-70967432020-03-31 Two year efficacy and safety of small versus large ABSORB bioresorbable vascular scaffolds of ≤18 mm device length: A subgroup analysis of the German-Austrian ABSORB RegIstRy (GABI-R) Zaczkiewicz, Myron Wein, Bastian Graf, Matthias Zimmermann, Oliver Kastner, Johannes Wöhrle, Jochen Thomas, Riemer Hamm, Christian Torzewski, Jan Int J Cardiol Heart Vasc Original Paper AIMS: The ABSORB bioresorbable vascular scaffold raised safety concerns due to higher rates of scaffold thrombosis (ScT) and adequate scaffold diameter and length for scaffold technology. Smaller scaffold diameter (SScD, 2.5 mm) was an infrequently quoted predictor of major adverse cardiac events (MACE). Therefore, we evaluated the impact of SScD compared to large scaffold diameter (LScD, ≥3 mm) of ≤18 mm device length on 2 year outcome in the all-comer real life GABI-R cohort. METHODS AND RESULTS: We compared patients with implanted LScD (1341 patients) vs. SScD (444 patients) of ≤18 mm device length. Patients with LScD more often presented with ST-elevation myocardial infarction (35.8% vs. 20.6%, p < 0.0001) and single-vessel disease (50.6% vs. 36.5% p < 0.0001). After a 24 months follow-up, there was no difference in regard of MACE (9.66% vs. 12.31%, p = 0.14) or definite/probable ST (2.47% vs. 2.82%, p = 0.71). Despite no difference in target lesion revascularisations (TLR) (5.81% vs. 7.71%, p = 0.18), there was a higher need for target vessel revascularisation (TVR) in the SScD-group (11.57% vs. 7.51%, p < 0.05). CONCLUSION: Compared to LScD, SScD of ≤18 mm device length demonstrated comparable safety in regard to MACE and ScT as well as efficacy in regard to TLR. Resorbable scaffold technology should not be restricted to large vessel diameters. CLINICAL TRIAL REGISTRATION: https://clinicaltrials.gov/ct2/show/NCT02066623. Elsevier 2020-03-20 /pmc/articles/PMC7096743/ /pubmed/32258361 http://dx.doi.org/10.1016/j.ijcha.2020.100501 Text en © 2020 The Authors http://creativecommons.org/licenses/by-nc-nd/4.0/ This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).
spellingShingle Original Paper
Zaczkiewicz, Myron
Wein, Bastian
Graf, Matthias
Zimmermann, Oliver
Kastner, Johannes
Wöhrle, Jochen
Thomas, Riemer
Hamm, Christian
Torzewski, Jan
Two year efficacy and safety of small versus large ABSORB bioresorbable vascular scaffolds of ≤18 mm device length: A subgroup analysis of the German-Austrian ABSORB RegIstRy (GABI-R)
title Two year efficacy and safety of small versus large ABSORB bioresorbable vascular scaffolds of ≤18 mm device length: A subgroup analysis of the German-Austrian ABSORB RegIstRy (GABI-R)
title_full Two year efficacy and safety of small versus large ABSORB bioresorbable vascular scaffolds of ≤18 mm device length: A subgroup analysis of the German-Austrian ABSORB RegIstRy (GABI-R)
title_fullStr Two year efficacy and safety of small versus large ABSORB bioresorbable vascular scaffolds of ≤18 mm device length: A subgroup analysis of the German-Austrian ABSORB RegIstRy (GABI-R)
title_full_unstemmed Two year efficacy and safety of small versus large ABSORB bioresorbable vascular scaffolds of ≤18 mm device length: A subgroup analysis of the German-Austrian ABSORB RegIstRy (GABI-R)
title_short Two year efficacy and safety of small versus large ABSORB bioresorbable vascular scaffolds of ≤18 mm device length: A subgroup analysis of the German-Austrian ABSORB RegIstRy (GABI-R)
title_sort two year efficacy and safety of small versus large absorb bioresorbable vascular scaffolds of ≤18 mm device length: a subgroup analysis of the german-austrian absorb registry (gabi-r)
topic Original Paper
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7096743/
https://www.ncbi.nlm.nih.gov/pubmed/32258361
http://dx.doi.org/10.1016/j.ijcha.2020.100501
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