Optical Coherence Tomographic Image Pattern of Metallic Bioresorbable Vascular Scaffold Restenosis

Roa-Garrido, Jessica; Cardenal-Piris, Rosa; Amrawy, Ahmed Mahmoud El; Gómez-Menchero, Antonio; Freire, Santiago Jesús Camacho; Díaz‐Fernández, José Francisco

doi:10.1016/j.jcin.2017.11.025

Cited by 4 publications

(1 citation statement)

References 1 publication

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“…Complete SA and neointimal volumes throughout the scaffolded segment could not be determined due to the difficulty in recognizing patent struts; however, when the SA was analyzable, a significant reduction of SA was found compared to the postimplantation result at the same location. These findings are in line with seven recently published case reports on severe lumen reduction and scaffold collapse after Magmaris BRS implantation . Furthermore, acute recoil was only 5.3%, in line with current generation metallic DES and BVS .…”

Section: Discussionsupporting

confidence: 91%

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

Forero

Zandvoort

Masdjedi

et al. 2019

Cathet Cardio Intervent

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Objectives: To assess the performance of the commercially available Magmaris sirolimuseluting bioresorbable scaffold (BRS) with invasive imaging at different time points.Background: Coronary BRS with a magnesium backbone have been recently studied as an alternative to polymeric scaffolds, providing enhanced vessel support and a faster resorption rate. We aimed to assess the performance of the commercially available Magmaris sirolimus-eluting BRS at different time points.Methods: A prospective, single-center, nonrandomized study was performed at the Thoraxcenter, Erasmus Medical Center, Rotterdam, The Netherlands. Six patients with stable de novo coronary artery lesions underwent single-vessel revascularization with the Magmaris sirolimus-eluting BRS. Invasive follow-up including intravascular imaging using optical coherence tomography (OCT) was performed at different time points.Results: At a median of 8 months (range 4-12 months) target lesion failure occurred in one patient. Angiography revealed a late lumen loss of 0.59 ± 0.39 mm, a percentage diameter stenosis of 39.65 ± 15.81%, and a binary restenosis rate of 33.3%. OCT showed a significant reduction in both minimal lumen area (MLA) and scaffold area at the site of the MLA by 43.44 ± 28.62 and 38.20 ± 25.74%, respectively. A fast and heterogeneous scaffold degradation process was found with a significant reduction of patent struts at 4-5 months.Conclusions: Our findings show that the latest iteration of magnesium BRS suffers from premature dismantling, resulting in a higher than expected decrease in MLA. K E Y W O R D S bioresorbable scaffolds, constrictive remodeling, Magmaris sirolimus-eluting bioresorbable scaffold, scaffold bioresorption, scaffold collapse, scaffold recoil Abbreviations: AMS, absorbable magnesium scaffolds; BRS, bioresorbable scaffold; DAPT, dual antiplatelet therapy; DES, drug-eluting stent; DS, diameter stenosis; LA, lumen area; LLL, late lumen loss; MLA, minimal lumen area; MSA, minimal scaffold area; NC, noncompliant; OCT, optical coherence tomography; post-PCI, post-percutaneous coronary intervention; pre-PCI, prepercutaneous coronary intervention; QCA, quantitative coronary analysis; RVD, reference vessel diameter; SA, scaffold area; SE-MEA, scaffold expansion according to manufacturer's expected area; SE-RVA, scaffold expansion according to reference vessel area.

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Section: Discussionsupporting

confidence: 91%

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

Forero

Zandvoort

Masdjedi

et al. 2019

Cathet Cardio Intervent

View full text Add to dashboard Cite

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Second-Generation Drug-Eluting Resorbable Magnesium Scaffold: Review of the Clinical Evidence

Ozaki

García‐García

Shlofmitz

et al. 2020

Cardiovascular Revascularization Medicine

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Mechanism of Drug-Eluting Absorbable Metal Scaffold Restenosis

Ueki

Räber

Otsuka

et al. 2020

Circ: Cardiovascular Interventions

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Background: The pathomechanisms underlying restenosis of the bioabsorbable sirolimus-eluting metallic scaffold (Magmaris) remain unknown. Using serial optical coherence tomography, we investigated causes of restenosis, including the contribution of late scaffold recoil versus neointimal hyperplasia. Methods: Patients enrolled in BIOSOLVE-II undergoing serial angiography and optical coherence tomography (post-intervention and follow-up: 6 months and/or 1 year) were analyzed. Patients were divided into 2 groups according to angiographic in-scaffold late lumen loss (LLL) <0.5 or ≥0.5 mm. End points were late absolute scaffold recoil and neointimal hyperplasia area as assessed by optical coherence tomography. Results: Serial data were available for analysis from 70 patients (LLL <0.5 mm: n=41; LLL ≥0.5 mm: n=29). Patient and lesion characteristics were comparable, and there was no significant difference in mean and minimal scaffold area between groups at post-intervention. Late absolute scaffold recoil was less among patients with LLL <0.5 mm (0.53±0.68 mm 2 ) compared with those with LLL ≥0.5 mm (1.48±1.20 mm 2 ; P <0.001). Neointimal hyperplasia area was smaller among patients with LLL <0.5 mm at follow-up (1.47±0.33 mm 2 ) compared with patients with LLL ≥0.5 mm (1.68±0.34 mm 2 ; P =0.013). In a matched-frame analysis (post-intervention and follow-up), late absolute scaffold recoil varied according to the underlying plaque type (lipid: 0.63±1.23 mm 2 ; calcified: 0.81±1.44 mm 2 ; and fibrous: 1.20±1.52 mm 2 ; P <0.001), while there was no difference with regards to neointimal hyperplasia area ( P =0.132). Conclusions: In addition to neointimal hyperplasia, late scaffold recoil contributed significantly to LLL of sirolimus-eluting absorbable metal scaffolds. The extent of late scaffold recoil was dependent on the underlying plaque morphology and was the highest among fibrotic lesions. Registration: URL: https://www.clinicaltrials.gov . Unique identifier: NCT01960504.

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Optical Coherence Tomographic Image Pattern of Metallic Bioresorbable Vascular Scaffold Restenosis

Cited by 4 publications

References 1 publication

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

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

Second-Generation Drug-Eluting Resorbable Magnesium Scaffold: Review of the Clinical Evidence

Mechanism of Drug-Eluting Absorbable Metal Scaffold Restenosis

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