Sustained Safety and Efficacy of Magnesium Reabsorbable Scaffold: 2-Year Follow-Up Analysis From First Magmaris Multicenter Italian Registry

Galli, Stefano; Troiano, Sarah; Palloshi, Altin; Rapetto, Claudio; Pisano, Francesco; Aprigliano, Gianfranco; Leoncini, Massimo; Ravagnani, Paolo; Maestro, M. Del; Montorsi, Piero

doi:10.1016/j.carrev.2022.01.020

Cited by 6 publications

(6 citation statements)

References 22 publications

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“…DES with thinner struts are also associated with lower 1-year TLR, periprocedural myocardial infarction, and early stent thrombosis rates, as published in a recent systematic review and meta-regression analysis. 27 In BIOMAG-I, the safety profile of precursor scaffold versions was maintained with DREAMS 3G 5 , 7 , 10 , 16 ; TV-MI and scaffold thrombosis were absent, and only one (0.9%) CD-TLR occurred. Of note, the treated coronary segment had a relatively small reference vessel diameter (2.72 mm [SD 0.46]), and > three quarters of the lesions (76.9%) were AHA/ACC class B2/C.…”

Section: Discussionmentioning

confidence: 98%

“…The second-generation Drug-Eluting Resorbable Magnesium Scaffold (DREAMS 2G, commercial name Magmaris) obtained a CE mark in 2016 and has shown low target lesion failure (TLF) and scaffold thrombosis rates in multiple trials. 5 , 6 , 7 , 8 Nevertheless, in-scaffold late lumen loss (LLL) with DREAMS 2G was not comparable to that observed with historical PLLA-based scaffolds or contemporary DES. 9 , 10 This led to the development of the third-generation drug-eluting magnesium scaffold (DREAMS 3G), which has a new magnesium alloy allowing improved mechanical properties and thinner struts, a new marker concept, and an increased size portfolio, with the resorption time remaining unchanged.…”

Section: Introductionmentioning

confidence: 93%

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Safety and performance of the third-generation drug-eluting resorbable coronary magnesium scaffold system in the treatment of subjects with de novo coronary artery lesions: 6-month results of the prospective, multicenter BIOMAG-I first-in-human study

Haude¹,

Włodarczak²,

Schaaf³

et al. 2023

eClinicalMedicine

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Section: Discussionmentioning

confidence: 98%

Section: Introductionmentioning

confidence: 93%

Safety and performance of the third-generation drug-eluting resorbable coronary magnesium scaffold system in the treatment of subjects with de novo coronary artery lesions: 6-month results of the prospective, multicenter BIOMAG-I first-in-human study

Haude¹,

Włodarczak²,

Schaaf³

et al. 2023

eClinicalMedicine

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“…2) Magmaris BRS did not present any definite scaffold-related thrombosis after a 24-month observation period. Data regarding the long-term evaluation of Magmaris BRS are rather sparse and mainly originate from retrospective observational clinical registries [20,[27][28][29]. Based on Advances in Interventional Cardiology 2024; 20, 1 (75) this single-arm evaluation despite all of its methodological shortcomings Magmaris showed favorable long-term safety and clinical performance with acceptable target lesion failure rates (5.2% up to 11%), which is comparable to our findings (5.6%) and analogous to novel DES performance [30][31][32].…”

Section: Discussionmentioning

confidence: 99%

Magnesium bioresorbable scaffold (Magmaris) versus polymer biodegradable ultrathin drug-eluting stent (Ultimaster) in acute coronary syndrome. Mid-term outcomes (2 years)

Włodarczak,

Rola,

Włodarczak

et al. 2024

pwki

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Introduction Acute coronary syndrome (ACS) is a well-known risk factor for adverse clinical outcomes in percutaneous coronary intervention (PCI). Therefore, evaluation of coronary stents in this challenging clinical scenario can provide unique information on device safety and efficacy. Bioresorbable scaffolds (BRS) were designed to overcome long-term complications related to permanent vessel caging with a permanent metallic drug-eluting stent (DES). Aim We designed this study to evaluate the mid-term safety and efficiency of the Magmaris BRS in comparison to the leading new-generation ultrathin DES Ultimaster in the ACS population. Material and methods We present a retrospective analysis of 2-year follow-up data. The primary outcomes consisted of death from cardiac causes, myocardial infarction, and in-stent thrombosis. The second main study endpoint was defined as target-lesion failure (TLF). Results The study population consisted of two cohorts, the first of 193 patients treated with Magmaris implantation and the second of 169 patients treated with Ultimaster implantation. At the 2-year follow-up, there were no significant differences in both study cohorts in terms of primary outcome (5.1% vs. 11%; p = 0.051), and TLF (5.6% vs. 8%, p = 0.41). Conclusions Treatment with a second-generation BRS (Magmaris) versus a novel second-generation DES (Ultimaster) in non-ST-elevation acute coronary syndrome (NSTE-ACS) was associated with similar rates of target lesion failure at 2-year follow-up.

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“…Despite reported lumen loss after implantation of the MgBRS in various intravascular imaging studies 19,22 , the clinical performance is still deemed safe and efficient in several studies. Registries have reported safety and efficacy with low 1-year TLF rates of 3.3-5.4% and stent thrombosis rates of 0.5%, and TLF of 7.8% and scaffold thrombosis of 0.5% up to 24 months after implantation 9,28,29 . A registry study found no difference in 24-month clinical outcomes between patients with acute vs. stable coronary syndromes who were treated with a MgBRS 30 .…”

Section: Discussionmentioning

confidence: 99%

Optimal Pre-dilatation Treatment before Implantation of a Magmaris Bioresorbable Scaffold in Coronary Artery Stenosis. The OPTIMIS trial

Hansen,

Trøan,

Maehara

et al. 2024

Preprint

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Introduction: Bioresorbable scaffolds (BRS) have been developed to overcome limitations related to late stent failures of drug-eluting-stents, but previous studies have observed lumen reduction over time after implantation of BRS. The aim of the study was to investigate if lesion preparation with a scoring balloon compared to a standard non-compliant balloon minimizes lumen reduction after implantation of a Magmaris BRS (MgBRS) assessed with optical coherence tomography (OCT) and intravascular ultrasound (IVUS). Method: Eighty-two patients with stable angina pectoris were included and randomized in a ratio 1:1 to lesion preparation with either a scoring balloon or a standard non-compliant balloon prior to implantation of a MgBRS. The primary endpoint was minimal lumen area (MLA) 6 months after MgBRS implantation. Results: Following MgBRS implantation, MLA (6.4 ± 1.6 mm2 vs. 6.3 ± 1.5 mm2, p=0.65), mean scaffold area (7.8 ± 1.5 mm2 vs. 7.5 ± 1.7 mm2, p=0.37), and mean lumen area (8.0 ± 1.6 mm2 vs. 7.7 ± 2.1 mm2, p=0.41) did not differ significantly in patients where the lesions were prepared with scoring vs. standard non-compliant balloon respectively. Six-month angiographic follow-up with OCT and IVUS was available in seventy-four patients. The primary endpoint, 6-months MLA, was significantly larger in lesions prepared with a scoring balloon compared to a standard non-compliant balloon (4.7 ± 1.4 mm2 vs. 3.9 ± 1.9 mm2, p=0.04), whereas mean lumen area (7.2 ± 1.4 mm3 vs. 6.8 ± 2.2, p=0.35) did not differ significantly. IVUS findings showed no difference in mean vessel area at the lesion site from baseline to follow-up in the scoring balloon group (16.8 ± 2.9 mm2 vs. 17.0 ± 3.6 mm2, p=0.62), whereas mean vessel area (17.1 ± 4.4 mm2 vs. 15.7 ± 4.9 mm2, p<0.001) was smaller in lesions prepared with a standard non-compliant balloon due to negative remodeling. Conclusion: Lesion preparation with a scoring balloon prior to implantation of a MgBRS resulted in significantly larger MLA after 6 months due to less negative remodeling compared to lesion preparation with a standard non-compliant balloon. Registration: URL: https://www.clinicaltrials.gov; Unique identifier:NCT04666584.

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Sustained Safety and Efficacy of Magnesium Reabsorbable Scaffold: 2-Year Follow-Up Analysis From First Magmaris Multicenter Italian Registry

Cited by 6 publications

References 22 publications

Safety and performance of the third-generation drug-eluting resorbable coronary magnesium scaffold system in the treatment of subjects with de novo coronary artery lesions: 6-month results of the prospective, multicenter BIOMAG-I first-in-human study

Safety and performance of the third-generation drug-eluting resorbable coronary magnesium scaffold system in the treatment of subjects with de novo coronary artery lesions: 6-month results of the prospective, multicenter BIOMAG-I first-in-human study

Magnesium bioresorbable scaffold (Magmaris) versus polymer biodegradable ultrathin drug-eluting stent (Ultimaster) in acute coronary syndrome. Mid-term outcomes (2 years)

Optimal Pre-dilatation Treatment before Implantation of a Magmaris Bioresorbable Scaffold in Coronary Artery Stenosis. The OPTIMIS trial

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