Serial invasive imaging follow‐up of the first clinical experience with the Magmaris magnesium bioresorbable scaffold

Forero, Maria Natalia Tovar; Zandvoort, Laurens van; Masdjedi, Kaneshka; Diletti, Roberto; Wilschut, Jeroen; Jaegere, Peter P. de; Zijlstra, Felix; Mieghem, Nicolas Van; Daemen, Joost

doi:10.1002/ccd.28304

Cited by 7 publications

(7 citation statements)

References 24 publications

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“…Recently, case reports of early scaffold restenosis have been published. 17 , 18 , 19 The terminology of the underlying failure is heterogeneous and warrants clear definitions as currently terms such as early or late recoil, compression, collapse, dismantling, and malapposition are used interchangeably. Underlying causes are discussed to be related to under‐ or overexpanded devices and/or to the mechanical properties of Magmaris.…”

Section: Discussionmentioning

confidence: 99%

“…That is compensated with thicker struts, but still, situations such as calcified lesions should be avoided. 11 , 17 Undoubtedly, there is a trade‐off between scaffolding the vessel long enough to prevent restenosis versus fast resorption to allow restoration of vascular function, physiological vasomotion, and to prevent scaffold thrombosis 18 , 19 , 21 , 22 ; the optimal degradation time is still unknown.…”

Section: Discussionmentioning

confidence: 99%

“…Recently, case reports of early scaffold restenosis have been published. [17][18][19] The terminology of the underlying failure is heterogeneous Magmaris. Noteworthy, although magnesium has several advantages similar to stainless steel stents, for example, low elastic recoil, minimal shortening after inflation, and higher initial radial strength than the polymeric Absorb scaffold, 20 its radial strength is still lower than cobalt chromium.…”

Section: Discussionmentioning

confidence: 99%

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BIOSOLVE‐IV‐registry: Safety and performance of the Magmaris scaffold: 12‐month outcomes of the first cohort of 1,075 patients

Verheye

Włodarczak²,

Montorsi

et al. 2020

Cathet Cardio Intervent

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Objectives We aimed to assess the safety and performance of the Magmaris sirolimus‐eluting bioresorbable magnesium scaffold in a large patient population. Background Magmaris has shown good outcomes in small‐sized controlled trials, but further data are needed to confirm its usability, safety, and performance. Methods BIOSOLVE‐IV is an international, single arm, multicenter registry including patients with a maximum of two single de novo lesions. Follow‐up is scheduled up to 5 years; the primary outcome is target lesion failure (TLF) at 12 months. Results A total of 1,075 patients with 1,121 lesions were enrolled. Mean patient age was 61.3 ± 10.5 years and 19.2% ( n = 206) presented with non‐ST‐elevation myocardial infarction (NSTEMI). Lesions were 3.2 ± 0.3 mm in diameter and 14.9 ± 4.2 mm long; 5.1% ( n = 57) were bifurcation lesions. Device success was 97.3% ( n = 1,129) and procedure success 98.9% ( n = 1,063). The Kaplan–Meier estimate of TLF at 12 months was 4.3% [95% confidence interval, CI: 3.2, 5.7] consisting of 3.9% target lesion revascularizations, 0.2% cardiac death, and 1.1% target‐vessel myocardial infarction. Definite/probable scaffold thrombosis occurred in five patients (0.5% [95% CI: 0.2, 1.1]), thereof four after early discontinuation of antiplatelet/anticoagulation therapy. Conclusion BIOSOLVE‐IV confirms the safety and performance of the Magmaris scaffold in a large population with excellent device and procedure success and a very good safety profile up to 12 months in a low‐risk population.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

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BIOSOLVE‐IV‐registry: Safety and performance of the Magmaris scaffold: 12‐month outcomes of the first cohort of 1,075 patients

Verheye

Włodarczak²,

Montorsi

et al. 2020

Cathet Cardio Intervent

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“…Beyond data coming from BIOSOLVE studies, an OCT case series including 6 patients with follow‐up was recently published by another group 15 . Compared to our study, all patients were stable and were treated with a single scaffold and 5 over 6 lesions were type B1 (ACC/AHA classification).…”

Section: Discussionmentioning

confidence: 65%

Anatomical and functional healing after resorbable magnesium scaffold implantation in human coronary vessels: A combined optical coherence tomography and quantitative flow ratio analysis

Cerrato

Belliggiano

Quadri

et al. 2020

Cathet Cardio Intervent

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Background: No data are currently available on the process of vessel healing and long-term physiological results after implantation of resorbable magnesium-made scaffold (RMS) in human coronary arteries.Objectives: To investigate after percutaneous coronary intervention (PCI) and at 12 months follow-up (a) RMS resorption process and vessel healing, as judged by optical coherence tomography (OCT) imaging; and (b) physiological result of RMS implantation evaluated by quantitative flow ratio (QFR).Methods: All patients successfully treated with at least one RMS from July 2016 to August 2018 at 2 Italian centers were evaluated. All cases with OCT pullback and/or coronary angiography suitable for QFR analysis performed after PCI and at 12 months were included. Resorption process was analyzed at OCT in each frame reporting presence of residual struts in the vessel.Results: Forty-four patients/forty-nine lesions were included. 12-months mean lumen area (LA; 7.54 ± 3.04 mm 2 ) significantly decreased compared to mean LA recorded immediately after PCI (8.12 ± 1.89 mm 2 ; p < .01). However, LA changes did not affect the functional result of PCI with a non-ischemic QFR value (>0.80) in 98% of cases at 12-months follow-up. Protruding struts were detectable in more than half of cases and their presence was correlated with an increase in mean LA (+0.73mm 2 [95% CI 0.51-0.94], p < .001).Conclusions: RMS implantation in a real-world population lead to significant decrease in mean LA without significant functional impairment. Two different patterns of RMS resorption were recorded, whose clinical significance remains to be investigated.

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“…So far, a series of non-randomized, controlled studies, including the BIOTRONIKS – Safety and Performance in de NOvo Lesion of NatiVE Coronary Arteries With Magmaris (BIOSOLVE) I-IV trials, showed promising outcomes after treatment with the Mg-BRS, including low rates of target lesion failure (TLF) (<5%) and ScT (<1%) ( 11 – 15 , 20 , 21 ). But, there have also been published cases, which highlighted the collapse and early dismantling of this device lately ( 22 , 23 ).…”

Section: Introductionmentioning

confidence: 99%

Long-Term Outcomes After Implantation of Magnesium-Based Bioresorbable Scaffolds—Insights From an All-Comer Registry

Bossard

Madanchi

Avdijaj

et al. 2022

Front. Cardiovasc. Med.

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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.

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Serial invasive imaging follow‐up of the first clinical experience with the Magmaris magnesium bioresorbable scaffold

Cited by 7 publications

References 24 publications

BIOSOLVE‐IV‐registry: Safety and performance of the Magmaris scaffold: 12‐month outcomes of the first cohort of 1,075 patients

BIOSOLVE‐IV‐registry: Safety and performance of the Magmaris scaffold: 12‐month outcomes of the first cohort of 1,075 patients

Anatomical and functional healing after resorbable magnesium scaffold implantation in human coronary vessels: A combined optical coherence tomography and quantitative flow ratio analysis

Long-Term Outcomes After Implantation of Magnesium-Based Bioresorbable Scaffolds—Insights From an All-Comer Registry

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