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Long-Term Performance of the Magmaris Drug-Eluting Bioresorbable Metallic Scaffold in All-Comers Patients’ Population
Background: The long-term efficacy and safety of bioresorbable vascular scaffolds (BVS) in real world clinical practice including Magmaris need to be elucidated to better understand performance of this new and evolutive technology. The aim of this study was to evaluate long-term performance of Magma...
Autores principales: | , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
MDPI
2022
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9267727/ https://www.ncbi.nlm.nih.gov/pubmed/35807011 http://dx.doi.org/10.3390/jcm11133726 |
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author | Al Nooryani, Arif Aboushokka, Wael AlBaba, Bassam Kerfes, Jalal Abudaqa, Loai Bhatia, Amit Mansoor, Anoop Nageeb, Ruwaide Aleksandric, Srdjan Beleslin, Branko |
author_facet | Al Nooryani, Arif Aboushokka, Wael AlBaba, Bassam Kerfes, Jalal Abudaqa, Loai Bhatia, Amit Mansoor, Anoop Nageeb, Ruwaide Aleksandric, Srdjan Beleslin, Branko |
author_sort | Al Nooryani, Arif |
collection | PubMed |
description | Background: The long-term efficacy and safety of bioresorbable vascular scaffolds (BVS) in real world clinical practice including Magmaris need to be elucidated to better understand performance of this new and evolutive technology. The aim of this study was to evaluate long-term performance of Magmaris, drug-eluting bioresorbable metallic scaffold, in all-comers patients’ population. Methods: We included in this prospective registry first 54 patients (54 ± 11 years; male 46) treated with Magmaris, with at least 30 months of follow-up. Diabetes mellitus and acute coronary syndrome were present in 33 (61%) and 30 (56%) of the patients, respectively. Patients were followed for device- and patient-oriented cardiac events during a median follow-up of 47 months (DOCE–cardiac death, target vessel myocardial infarction, and target lesion revascularization; POCE–all cause death, any myocardial infarction, any revascularization). Results: Event-free survivals for DOCE and POCE were 86.8% and 79.2%, respectively. The rate of DOCE was 7/54 (13%), including in total target vessel myocardial infarction in two patients (4%), target lesion revascularization in six patients (11%), and no cardiac deaths. The rate of POCE was 11/54 (21%), including in total any myocardial infarctions in 3 patients (6%), any revascularization in 11 patients (20%), and no deaths. Definite Magmaris thrombosis occurred in two patients (3.7%), and in-scaffold restenosis developed in five patients (9.3%). Variables associated with DOCE were implantation of ≥2 Magmaris BVS (HR: 5.4; 95%CI: 1.21–24.456; p = 0.027) and total length of Magmaris BVS ≥ 40 mm (HR: 6.4; 95%CI: 1.419–28.855; p = 0.016), whereas previous PCI was the only independent predictor of POCE (HR: 7.4; 95%CI: 2.216–24.613; p = 0.001). Conclusions: The results of the long-term clinical outcome following Magmaris implantation in patients with complex clinical and angiographic features were acceptable and promising. Patients with multi-BVS and longer multi-BVS in lesion implantation were associated with worse clinical outcome. |
format | Online Article Text |
id | pubmed-9267727 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2022 |
publisher | MDPI |
record_format | MEDLINE/PubMed |
spelling | pubmed-92677272022-07-09 Long-Term Performance of the Magmaris Drug-Eluting Bioresorbable Metallic Scaffold in All-Comers Patients’ Population Al Nooryani, Arif Aboushokka, Wael AlBaba, Bassam Kerfes, Jalal Abudaqa, Loai Bhatia, Amit Mansoor, Anoop Nageeb, Ruwaide Aleksandric, Srdjan Beleslin, Branko J Clin Med Article Background: The long-term efficacy and safety of bioresorbable vascular scaffolds (BVS) in real world clinical practice including Magmaris need to be elucidated to better understand performance of this new and evolutive technology. The aim of this study was to evaluate long-term performance of Magmaris, drug-eluting bioresorbable metallic scaffold, in all-comers patients’ population. Methods: We included in this prospective registry first 54 patients (54 ± 11 years; male 46) treated with Magmaris, with at least 30 months of follow-up. Diabetes mellitus and acute coronary syndrome were present in 33 (61%) and 30 (56%) of the patients, respectively. Patients were followed for device- and patient-oriented cardiac events during a median follow-up of 47 months (DOCE–cardiac death, target vessel myocardial infarction, and target lesion revascularization; POCE–all cause death, any myocardial infarction, any revascularization). Results: Event-free survivals for DOCE and POCE were 86.8% and 79.2%, respectively. The rate of DOCE was 7/54 (13%), including in total target vessel myocardial infarction in two patients (4%), target lesion revascularization in six patients (11%), and no cardiac deaths. The rate of POCE was 11/54 (21%), including in total any myocardial infarctions in 3 patients (6%), any revascularization in 11 patients (20%), and no deaths. Definite Magmaris thrombosis occurred in two patients (3.7%), and in-scaffold restenosis developed in five patients (9.3%). Variables associated with DOCE were implantation of ≥2 Magmaris BVS (HR: 5.4; 95%CI: 1.21–24.456; p = 0.027) and total length of Magmaris BVS ≥ 40 mm (HR: 6.4; 95%CI: 1.419–28.855; p = 0.016), whereas previous PCI was the only independent predictor of POCE (HR: 7.4; 95%CI: 2.216–24.613; p = 0.001). Conclusions: The results of the long-term clinical outcome following Magmaris implantation in patients with complex clinical and angiographic features were acceptable and promising. Patients with multi-BVS and longer multi-BVS in lesion implantation were associated with worse clinical outcome. MDPI 2022-06-28 /pmc/articles/PMC9267727/ /pubmed/35807011 http://dx.doi.org/10.3390/jcm11133726 Text en © 2022 by the authors. https://creativecommons.org/licenses/by/4.0/Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (https://creativecommons.org/licenses/by/4.0/). |
spellingShingle | Article Al Nooryani, Arif Aboushokka, Wael AlBaba, Bassam Kerfes, Jalal Abudaqa, Loai Bhatia, Amit Mansoor, Anoop Nageeb, Ruwaide Aleksandric, Srdjan Beleslin, Branko Long-Term Performance of the Magmaris Drug-Eluting Bioresorbable Metallic Scaffold in All-Comers Patients’ Population |
title | Long-Term Performance of the Magmaris Drug-Eluting Bioresorbable Metallic Scaffold in All-Comers Patients’ Population |
title_full | Long-Term Performance of the Magmaris Drug-Eluting Bioresorbable Metallic Scaffold in All-Comers Patients’ Population |
title_fullStr | Long-Term Performance of the Magmaris Drug-Eluting Bioresorbable Metallic Scaffold in All-Comers Patients’ Population |
title_full_unstemmed | Long-Term Performance of the Magmaris Drug-Eluting Bioresorbable Metallic Scaffold in All-Comers Patients’ Population |
title_short | Long-Term Performance of the Magmaris Drug-Eluting Bioresorbable Metallic Scaffold in All-Comers Patients’ Population |
title_sort | long-term performance of the magmaris drug-eluting bioresorbable metallic scaffold in all-comers patients’ population |
topic | Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9267727/ https://www.ncbi.nlm.nih.gov/pubmed/35807011 http://dx.doi.org/10.3390/jcm11133726 |
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