Long-Term Outcomes After Implantation of Magnesium-Based Bioresorbable Scaffolds—Insights From an All-Comer Registry
BackgroundThe magnesium-based sirolimus-eluting bioresorbable scaffold (Mg-BRS) Magmaris™ showed promising clinical outcomes, including low rates of both the target lesion failure (TLF) and scaffold thrombosis (ScT), in selected study patients. However, insights regarding long-term outcomes (>...
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| Format: | Article |
| Language: | English |
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Frontiers Media S.A.
2022-04-01
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| Series: | Frontiers in Cardiovascular Medicine |
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| Online Access: | https://www.frontiersin.org/articles/10.3389/fcvm.2022.856930/full |
| _version_ | 1818273809242783744 |
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| author | Matthias Bossard Mehdi Madanchi Dardan Avdijaj Dardan Avdijaj Adrian Attinger-Toller Giacomo Maria Cioffi Thomas Seiler Gregorio Tersalvi Richard Kobza Guido Schüpfer Florim Cuculi |
| author_facet | Matthias Bossard Mehdi Madanchi Dardan Avdijaj Dardan Avdijaj Adrian Attinger-Toller Giacomo Maria Cioffi Thomas Seiler Gregorio Tersalvi Richard Kobza Guido Schüpfer Florim Cuculi |
| author_sort | Matthias Bossard |
| collection | DOAJ |
| description | BackgroundThe magnesium-based sirolimus-eluting bioresorbable scaffold (Mg-BRS) Magmaris™ showed promising clinical outcomes, including low rates of both the target lesion failure (TLF) and scaffold thrombosis (ScT), in selected study patients. However, insights regarding long-term outcomes (>2 years) in all-comer populations remain scarce.MethodsWe analyzed data from a single-center registry, including patients with acute coronary syndrome (ACS) and chronic coronary syndrome (CCS), who had undergone percutaneous coronary intervention (PCI) using the Mg-BRS. The primary outcome comprised the device-oriented composite endpoint (DoCE) representing a hierarchical composite of cardiac death, ScT, target vessel myocardial infarction (TV-MI), and clinically driven target lesion revascularization (TLR) up to 5 years.ResultsIn total, 84 patients [mean age 62 ± 11 years and 63 (75%) men] were treated with the Mg-BRS devices between June 2016 and March 2017. Overall, 101 lesions had successfully been treated with the Mg-BRS devices using 1.2 ± 0.4 devices per lesion. Pre- and postdilatation using dedicated devices had been performed in 101 (100%) and 98 (97%) of all the cases, respectively. After a median follow-up time of 62 (61–64) months, 14 (18%) patients had experienced DoCEs, whereas ScT was encountered in 4 (4.9%) patients [early ScTs (<30 days) in three cases and two fatal cases]. In 4 (29%) of DoCE cases, optical coherence tomography confirmed the Mg-BRS collapse and uncontrolled dismantling.ConclusionIn contradiction to earlier studies, we encountered a relatively high rate of DoCEs in an all-comer cohort treated with the Mg-BRS. We even observed scaffold collapse and uncontrolled dismantling. This implicates that this metal-based BRS requires further investigation and may only be used in highly selected cases. |
| first_indexed | 2024-12-12T22:03:52Z |
| format | Article |
| id | doaj.art-4b75e366fb304ff39976746f2a36b4ed |
| institution | Directory Open Access Journal |
| issn | 2297-055X |
| language | English |
| last_indexed | 2024-12-12T22:03:52Z |
| publishDate | 2022-04-01 |
| publisher | Frontiers Media S.A. |
| record_format | Article |
| series | Frontiers in Cardiovascular Medicine |
| spelling | doaj.art-4b75e366fb304ff39976746f2a36b4ed2022-12-22T00:10:26ZengFrontiers Media S.A.Frontiers in Cardiovascular Medicine2297-055X2022-04-01910.3389/fcvm.2022.856930856930Long-Term Outcomes After Implantation of Magnesium-Based Bioresorbable Scaffolds—Insights From an All-Comer RegistryMatthias Bossard0Mehdi Madanchi1Dardan Avdijaj2Dardan Avdijaj3Adrian Attinger-Toller4Giacomo Maria Cioffi5Thomas Seiler6Gregorio Tersalvi7Richard Kobza8Guido Schüpfer9Florim Cuculi10Cardiology Division, Heart Center, Luzerner Kantonsspital, Luzern, SwitzerlandCardiology Division, Heart Center, Luzerner Kantonsspital, Luzern, SwitzerlandCardiology Division, Heart Center, Luzerner Kantonsspital, Luzern, SwitzerlandFaculty of Medicine, University of Zurich, Luzern, SwitzerlandCardiology Division, Heart Center, Luzerner Kantonsspital, Luzern, SwitzerlandCardiology Division, Heart Center, Luzerner Kantonsspital, Luzern, SwitzerlandCardiology Division, Heart Center, Luzerner Kantonsspital, Luzern, SwitzerlandCardiology Division, Heart Center, Luzerner Kantonsspital, Luzern, SwitzerlandCardiology Division, Heart Center, Luzerner Kantonsspital, Luzern, SwitzerlandDepartment of Anaestesiology, Luzerner Kantonsspital, Luzern, SwitzerlandCardiology Division, Heart Center, Luzerner Kantonsspital, Luzern, SwitzerlandBackgroundThe magnesium-based sirolimus-eluting bioresorbable scaffold (Mg-BRS) Magmaris™ showed promising clinical outcomes, including low rates of both the target lesion failure (TLF) and scaffold thrombosis (ScT), in selected study patients. However, insights regarding long-term outcomes (>2 years) in all-comer populations remain scarce.MethodsWe analyzed data from a single-center registry, including patients with acute coronary syndrome (ACS) and chronic coronary syndrome (CCS), who had undergone percutaneous coronary intervention (PCI) using the Mg-BRS. The primary outcome comprised the device-oriented composite endpoint (DoCE) representing a hierarchical composite of cardiac death, ScT, target vessel myocardial infarction (TV-MI), and clinically driven target lesion revascularization (TLR) up to 5 years.ResultsIn total, 84 patients [mean age 62 ± 11 years and 63 (75%) men] were treated with the Mg-BRS devices between June 2016 and March 2017. Overall, 101 lesions had successfully been treated with the Mg-BRS devices using 1.2 ± 0.4 devices per lesion. Pre- and postdilatation using dedicated devices had been performed in 101 (100%) and 98 (97%) of all the cases, respectively. After a median follow-up time of 62 (61–64) months, 14 (18%) patients had experienced DoCEs, whereas ScT was encountered in 4 (4.9%) patients [early ScTs (<30 days) in three cases and two fatal cases]. In 4 (29%) of DoCE cases, optical coherence tomography confirmed the Mg-BRS collapse and uncontrolled dismantling.ConclusionIn contradiction to earlier studies, we encountered a relatively high rate of DoCEs in an all-comer cohort treated with the Mg-BRS. We even observed scaffold collapse and uncontrolled dismantling. This implicates that this metal-based BRS requires further investigation and may only be used in highly selected cases.https://www.frontiersin.org/articles/10.3389/fcvm.2022.856930/fullbioresorbable scaffold (BRS)Magmarispercutaneous coronary interventionscaffold thrombosisstentmagnesium |
| spellingShingle | Matthias Bossard Mehdi Madanchi Dardan Avdijaj Dardan Avdijaj Adrian Attinger-Toller Giacomo Maria Cioffi Thomas Seiler Gregorio Tersalvi Richard Kobza Guido Schüpfer Florim Cuculi Long-Term Outcomes After Implantation of Magnesium-Based Bioresorbable Scaffolds—Insights From an All-Comer Registry Frontiers in Cardiovascular Medicine bioresorbable scaffold (BRS) Magmaris percutaneous coronary intervention scaffold thrombosis stent magnesium |
| title | Long-Term Outcomes After Implantation of Magnesium-Based Bioresorbable Scaffolds—Insights From an All-Comer Registry |
| title_full | Long-Term Outcomes After Implantation of Magnesium-Based Bioresorbable Scaffolds—Insights From an All-Comer Registry |
| title_fullStr | Long-Term Outcomes After Implantation of Magnesium-Based Bioresorbable Scaffolds—Insights From an All-Comer Registry |
| title_full_unstemmed | Long-Term Outcomes After Implantation of Magnesium-Based Bioresorbable Scaffolds—Insights From an All-Comer Registry |
| title_short | Long-Term Outcomes After Implantation of Magnesium-Based Bioresorbable Scaffolds—Insights From an All-Comer Registry |
| title_sort | long term outcomes after implantation of magnesium based bioresorbable scaffolds insights from an all comer registry |
| topic | bioresorbable scaffold (BRS) Magmaris percutaneous coronary intervention scaffold thrombosis stent magnesium |
| url | https://www.frontiersin.org/articles/10.3389/fcvm.2022.856930/full |
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