Case report
Feasibility of use of magnesium reabsorbable scaffolds in complex coronary artery disease: True bifurcation, multiple overlapping scaffolds and chronic total occlusion treatment
Exequibilidade de stents bioabsorbíveis de magnésio na doença coronária complexa: bifurcação verdadeira, stents sobrepostos múltiplos e tratamento da oclusão crónica total
Jeremías Bayón
, Melisa Santá-Álvarez, Raymundo Ocaranza-Sánchez, Carlos González-Juanatey
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Hospital Universitario Lucus Augusti, Lugo, Galicia, Spain
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"apellidos" => "Pinto" ] 9 => array:2 [ "nombre" => "Rui Cruz" "apellidos" => "Ferreira" ] ] ] ] ] "idiomaDefecto" => "en" "EPUB" => "https://multimedia.elsevier.es/PublicationsMultimediaV1/item/epub/S0870255117301555?idApp=UINPBA00004E" "url" => "/08702551/0000003700000012/v3_201911281020/S0870255117301555/v3_201911281020/en/main.assets" ] "en" => array:19 [ "idiomaDefecto" => true "cabecera" => "<span class="elsevierStyleTextfn">Case report</span>" "titulo" => "Feasibility of use of magnesium reabsorbable scaffolds in complex coronary artery disease: True bifurcation, multiple overlapping scaffolds and chronic total occlusion treatment" "tieneTextoCompleto" => true "paginas" => array:1 [ 0 => array:2 [ "paginaInicial" => "1009.e1" "paginaFinal" => "1009.e3" ] ] "autores" => array:1 [ 0 => array:4 [ "autoresLista" => "Jeremías Bayón, Melisa Santá-Álvarez, Raymundo Ocaranza-Sánchez, Carlos González-Juanatey" "autores" => array:4 [ 0 => array:4 [ "nombre" => "Jeremías" "apellidos" => "Bayón" "email" => array:1 [ 0 => "jerebayon@gmail.com" ] "referencia" => array:1 [ 0 => array:2 [ "etiqueta" => "<span class="elsevierStyleSup">*</span>" "identificador" => "cor0005" ] ] ] 1 => array:2 [ "nombre" => "Melisa" "apellidos" => "Santá-Álvarez" ] 2 => array:2 [ "nombre" => "Raymundo" "apellidos" => "Ocaranza-Sánchez" ] 3 => array:2 [ "nombre" => "Carlos" "apellidos" => "González-Juanatey" ] ] "afiliaciones" => array:1 [ 0 => array:2 [ "entidad" => "Hospital Universitario Lucus Augusti, Lugo, Galicia, Spain" "identificador" => "aff0005" ] ] "correspondencia" => array:1 [ 0 => array:3 [ "identificador" => "cor0005" "etiqueta" => "⁎" "correspondencia" => "Corresponding author." ] ] ] ] "titulosAlternativos" => array:1 [ "pt" => array:1 [ "titulo" => "Exequibilidade de <span class="elsevierStyleItalic">stents</span> bioabsorbíveis de magnésio na doença coronária complexa: bifurcação verdadeira, <span class="elsevierStyleItalic">stents</span> sobrepostos múltiplos e tratamento da oclusão crónica total" ] ] "resumenGrafico" => array:2 [ "original" => 0 "multimedia" => array:7 [ "identificador" => "fig0005" "etiqueta" => "Figure 1" "tipo" => "MULTIMEDIAFIGURA" "mostrarFloat" => true "mostrarDisplay" => false "figura" => array:1 [ 0 => array:4 [ "imagen" => "gr1.jpeg" "Alto" => 1660 "Ancho" => 2500 "Tamanyo" => 538246 ] ] "descripcion" => array:1 [ "en" => "<p id="spar0015" class="elsevierStyleSimplePara elsevierViewall">Coronary angiography at baseline, post-percutaneous intervention with implantation of Magmaris devices, and follow-up at three months. CX: circumflex; LAD: left anterior descending.</p>" ] ] ] "textoCompleto" => "<span class="elsevierStyleSections"><span id="sec0005" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0025">Introduction</span><p id="par0005" class="elsevierStylePara elsevierViewall">The Magmaris bioabsorbable sirolimus-releasing magnesium scaffold (Biotronik) is the first device of its kind that is clinically tested and with proven safety data. It features a metallic magnesium backbone with corrugated ring design, six crowns and strut thickness of 150×150 μm. In vitro tests have demonstrated greater radial strength, 20% less recoil and 80% more flexibility than the Absorb bioabsorbable sirolimus-releasing polylactic acid (PLLA) scaffold (Abbott).<a class="elsevierStyleCrossRef" href="#bib0030"><span class="elsevierStyleSup">1</span></a></p><p id="par0010" class="elsevierStylePara elsevierViewall">The magnesium backbone is coated with a compound called BIOlute, a resorbable PLLA polymer which delivers controlled release of the sirolimus drug for up to 90 days and which is metabolized in the body to carbon dioxide and water. The absorption process is rapid, with 95% of the magnesium being reabsorbed within twelve months.<a class="elsevierStyleCrossRef" href="#bib0035"><span class="elsevierStyleSup">2</span></a></p><p id="par0015" class="elsevierStylePara elsevierViewall">A safety study, BIOSOLVE I, enrolled 46 patients with 47 de novo lesions. Three-year follow-up results were obtained from 44 patients, which showed target lesion failure in three cases (6.6%), and no cardiac death or device thrombosis. Seven patients had additional angiographic follow-up at 28±4 months: in-scaffold late luminal loss had improved from 0.51±0.46 mm (median 0.28 mm) at 12 months to 0.32±0.32 mm (median 0.20 mm).<a class="elsevierStyleCrossRef" href="#bib0040"><span class="elsevierStyleSup">3</span></a></p><p id="par0020" class="elsevierStylePara elsevierViewall">The 12-month results of BIOSOLVE-II have recently been published, enrolling 123 patients with de novo lesions with a reference diameter between 2.2 mm and 3.7 mm. Quantitative coronary angiography parameters were stable from 6 to 12 months (paired data of 42 patients: in-segment late lumen loss 0.20±0.21 mm vs. 0.25±0.22 mm, p=0.117; in-scaffold late lumen loss 0.37±0.25 mm vs. 0.39±0.27 mm, p=0.446, respectively. Intravascular ultrasound demonstrated preserved minimal luminal area at six months (6.24±1.15 mm<span class="elsevierStyleSup">2</span> after percutaneous coronary intervention [PCI] vs. 6.21±1.22 mm<span class="elsevierStyleSup">2</span> at six months), with a small neointimal area (0.08±0.09 mm<span class="elsevierStyleSup">2</span>). Optical coherence tomography (OCT) detected no intraluminal masses. Target lesion failure was observed in 3.4%, with no definite or probable scaffold thrombosis.<a class="elsevierStyleCrossRef" href="#bib0045"><span class="elsevierStyleSup">4</span></a></p><p id="par0025" class="elsevierStylePara elsevierViewall">Current recommendations for the Magmaris implant are de novo coronary lesions with a vessel diameter near the nominal size of the scaffold and a length shorter than the device. Among lesions not recommended or those in which special care has to be taken are total chronic occlusion, excessive tortuosity and side branches (bifurcations) greater than 2 mm in diameter.<a class="elsevierStyleCrossRef" href="#bib0050"><span class="elsevierStyleSup">5</span></a></p></span><span id="sec0010" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0030">Case report</span><p id="par0030" class="elsevierStylePara elsevierViewall">We present the case of a 65-year-old male with nickel allergy who was admitted to the hospital with non-ST-elevation acute coronary syndrome. Coronary angiography showed significant two-vessel coronary disease not suitable for surgical revascularization because of small caliber and diffuse disease. There were multiple tandem lesions from the proximal to the distal left anterior descending (LAD) artery, bifurcated (Medina 1,1,1) with a diagonal branch, and a chronic total occlusion (CTO) in the mid circumflex (CX) (<a class="elsevierStyleCrossRef" href="#fig0005">Figure 1</a>).</p><elsevierMultimedia ident="fig0005"></elsevierMultimedia><p id="par0035" class="elsevierStylePara elsevierViewall">The patient was on aspirin so a loading dose of 180 mg ticagrelor was added. For the coronary angiography 8000 U heparin (weight-adjusted) and 300 μg intracoronary nitroglycerine were administered, in order to obtain a better assessment of the actual size of the coronary arteries. No imaging techniques were performed because of difficulty in crossing the lesion.</p><p id="par0040" class="elsevierStylePara elsevierViewall">The LAD was treated, first with predilatation with a 3.0 mm×20 mm non-complaint balloon in the distal LAD and the diagonal branch, and a 3.5 mm×20 mm balloon in the proximal LAD (balloon-scaffold ratio 1:1). Sequential and overlapping Magmaris scaffolds were then implanted (leaving 1 mm between the devices) from the distal LAD (one 3 mm×15 mm and two 3.5 mm×25 mm) to the bifurcation with the diagonal. StentBoost image enhancement (Philips) was used to adjust the overlap. Two more Magmaris scaffolds were then implanted in the median LAD (3.5 mm×25 mm) and the diagonal (3 mm×15 mm) by the reverse T and protrusion technique. The CTO of the CX was treated with a 3 mm×25 mm Magmaris. The scaffolds were implanted according to the manufacturer's recommendations to adequately predilate the lesion, select a device diameter very similar to vessel size, and postdilate without exceeding 0.6 mm above the nominal size of the device (<a class="elsevierStyleCrossRef" href="#fig0005">Figure 1</a>). In this case, we used non-compliant balloons with a 1:1 ratio except for the scaffold in the proximal LAD, which was postdilated with a 4.0 mm×20 mm non-compliant balloon. The final result was confirmed by OCT.</p><p id="par0045" class="elsevierStylePara elsevierViewall">The patient was discharged with recommendation for 12 months dual antiplatelet therapy with aspirin 100 mg daily and ticagrelor 90 mg twice daily.</p><p id="par0050" class="elsevierStylePara elsevierViewall">At three months, with no symptoms and with the patient's consent, coronary angiography was repeated (<a class="elsevierStyleCrossRef" href="#fig0005">Figure 1</a>). Three-month OCT showed appropriate strut apposition and partial covering of the majority of the struts (<a class="elsevierStyleCrossRef" href="#fig0010">Figure 2</a>).</p><elsevierMultimedia ident="fig0010"></elsevierMultimedia></span><span id="sec0015" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0035">Conclusion</span><p id="par0055" class="elsevierStylePara elsevierViewall">We present first-in-human complex PCI in a patient with nickel allergy treated with Magmaris bioabsorbable sirolimus-releasing magnesium scaffolds (Biotronik). We highlight the good apposition in the CTO lesion and the true bifurcation and overlapping in the LAD, with good results on OCT. This novel device is becoming a real option in these patients.</p></span><span id="sec0020" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0040">Conflicts of interest</span><p id="par0060" class="elsevierStylePara elsevierViewall">The authors have no conflicts of interest to declare.</p></span></span>" "textoCompletoSecciones" => array:1 [ "secciones" => array:9 [ 0 => array:3 [ "identificador" => "xres1269360" "titulo" => "Abstract" "secciones" => array:1 [ 0 => array:1 [ "identificador" => "abst0005" ] ] ] 1 => array:2 [ "identificador" => "xpalclavsec1174876" "titulo" => "Keywords" ] 2 => array:3 [ "identificador" => "xres1269359" "titulo" => "Resumo" "secciones" => array:1 [ 0 => array:1 [ "identificador" => "abst0010" ] ] ] 3 => array:2 [ "identificador" => "xpalclavsec1174875" "titulo" => "Palavras-chave" ] 4 => array:2 [ "identificador" => "sec0005" "titulo" => "Introduction" ] 5 => array:2 [ "identificador" => "sec0010" "titulo" => "Case report" ] 6 => array:2 [ "identificador" => "sec0015" "titulo" => "Conclusion" ] 7 => array:2 [ "identificador" => "sec0020" "titulo" => "Conflicts of interest" ] 8 => array:1 [ "titulo" => "References" ] ] ] "pdfFichero" => "main.pdf" "tienePdf" => true "fechaRecibido" => "2017-06-08" "fechaAceptado" => "2017-08-24" "PalabrasClave" => array:2 [ "en" => array:1 [ 0 => array:4 [ "clase" => "keyword" "titulo" => "Keywords" "identificador" => "xpalclavsec1174876" "palabras" => array:3 [ 0 => "Bioabsorbable magnesium scaffolds" 1 => "Nickel allergy" 2 => "Complex percutaneous coronary intervention" ] ] ] "pt" => array:1 [ 0 => array:4 [ "clase" => "keyword" "titulo" => "Palavras-chave" "identificador" => "xpalclavsec1174875" "palabras" => array:3 [ 0 => "Suportes bioabsorbíveis de magnésio" 1 => "Alergia ao níquel" 2 => "Intervenção coronária percutânea complexa" ] ] ] ] "tieneResumen" => true "resumen" => array:2 [ "en" => array:2 [ "titulo" => "Abstract" "resumen" => "<span id="abst0005" class="elsevierStyleSection elsevierViewall"><p id="spar0005" class="elsevierStyleSimplePara elsevierViewall">We present first-in-human treatment with bioabsorbable magnesium scaffolds for percutaneous coronary intervention in a patient with nickel allergy. We present images from angiography and optical coherence tomography at three months. We also review the current status of these novel devices.</p></span>" ] "pt" => array:2 [ "titulo" => "Resumo" "resumen" => "<span id="abst0010" class="elsevierStyleSection elsevierViewall"><p id="spar0010" class="elsevierStyleSimplePara elsevierViewall">Apresentamos pela primeira vez o tratamento com suportes bioabsorbíveis de magnésio na intervenção coronária percutânea complexa de doentes com alergia ao níquel. Incluímos a angiografia e as imagens da tomografia de coerência óptica efetuadas durante um período de três meses. Analisamos também o estado atual deste equipamento inovador.</p></span>" ] ] "multimedia" => array:2 [ 0 => array:7 [ "identificador" => "fig0005" "etiqueta" => "Figure 1" "tipo" => "MULTIMEDIAFIGURA" "mostrarFloat" => true "mostrarDisplay" => false "figura" => array:1 [ 0 => array:4 [ "imagen" => "gr1.jpeg" "Alto" => 1660 "Ancho" => 2500 "Tamanyo" => 538246 ] ] "descripcion" => array:1 [ "en" => "<p id="spar0015" class="elsevierStyleSimplePara elsevierViewall">Coronary angiography at baseline, post-percutaneous intervention with implantation of Magmaris devices, and follow-up at three months. CX: circumflex; LAD: left anterior descending.</p>" ] ] 1 => array:7 [ "identificador" => "fig0010" "etiqueta" => "Figure 2" "tipo" => "MULTIMEDIAFIGURA" "mostrarFloat" => true "mostrarDisplay" => false "figura" => array:1 [ 0 => array:4 [ "imagen" => "gr2.jpeg" "Alto" => 1856 "Ancho" => 2500 "Tamanyo" => 588892 ] ] "descripcion" => array:1 [ "en" => "<p id="spar0020" class="elsevierStyleSimplePara elsevierViewall">Optical coherence tomography images of the left anterior descending (LAD) and circumflex (CX) arteries, showing adequate apposition with partial covering of the struts. PCI: percutaneous coronary intervention.</p>" ] ] ] "bibliografia" => array:2 [ "titulo" => "References" "seccion" => array:1 [ 0 => array:2 [ "identificador" => "bibs0015" "bibliografiaReferencia" => array:5 [ 0 => array:3 [ "identificador" => "bib0030" "etiqueta" => "1" "referencia" => array:1 [ 0 => array:2 [ "contribucion" => array:1 [ 0 => array:2 [ "titulo" => "In vitro performance investigation of bioresorbable scaffolds – standard tests for vascular stents and beyond" "autores" => array:1 [ 0 => array:2 [ "etal" => true "autores" => array:3 [ 0 => "W. Schmidt" 1 => "P. Behrens" 2 => "C. 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Erne" ] ] ] ] ] "host" => array:1 [ 0 => array:2 [ "doi" => "10.4244/EIJ-D-15-00371" "Revista" => array:6 [ "tituloSerie" => "EuroIntervention" "fecha" => "2016" "volumen" => "12" "paginaInicial" => "e160" "paginaFinal" => "e166" "link" => array:1 [ 0 => array:2 [ "url" => "https://www.ncbi.nlm.nih.gov/pubmed/27290675" "web" => "Medline" ] ] ] ] ] ] ] ] 3 => array:3 [ "identificador" => "bib0045" "etiqueta" => "4" "referencia" => array:1 [ 0 => array:2 [ "contribucion" => array:1 [ 0 => array:2 [ "titulo" => "Sustained safety and performance of the second-generation drug-eluting absorbable metal scaffold in patients with de novo coronary lesions: 12-month clinical results and angiographic findings of the BIOSOLVE-II first-in-man trial" "autores" => array:1 [ 0 => array:2 [ "etal" => true "autores" => array:3 [ 0 => "M. Haude" 1 => "H. Ince" 2 => "A. Abizaid" ] ] ] ] ] "host" => array:1 [ 0 => array:2 [ "doi" => "10.1093/eurheartj/ehw196" "Revista" => array:6 [ "tituloSerie" => "Eur Heart J" "fecha" => "2016" "volumen" => "37" "paginaInicial" => "2701" "paginaFinal" => "2709" "link" => array:1 [ 0 => array:2 [ "url" => "https://www.ncbi.nlm.nih.gov/pubmed/27190094" "web" => "Medline" ] ] ] ] ] ] ] ] 4 => array:3 [ "identificador" => "bib0050" "etiqueta" => "5" "referencia" => array:1 [ 0 => array:2 [ "contribucion" => array:1 [ 0 => array:2 [ "titulo" => "Magmaris preliminary recommendation upon commercial launch: a consensus from the expert panel on 14 April 2016" "autores" => array:1 [ 0 => array:2 [ "etal" => true "autores" => array:3 [ 0 => "J. Fajadet" 1 => "M. Haude" 2 => "M. 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| Ano/Mês | Html | Total | |
|---|---|---|---|
| 2024 Novembro | 7 | 3 | 10 |
| 2024 Outubro | 43 | 33 | 76 |
| 2024 Setembro | 53 | 27 | 80 |
| 2024 Agosto | 81 | 29 | 110 |
| 2024 Julho | 49 | 37 | 86 |
| 2024 Junho | 54 | 35 | 89 |
| 2024 Maio | 53 | 22 | 75 |
| 2024 Abril | 55 | 32 | 87 |
| 2024 Maro | 48 | 22 | 70 |
| 2024 Fevereiro | 53 | 29 | 82 |
| 2024 Janeiro | 37 | 22 | 59 |
| 2023 Dezembro | 36 | 20 | 56 |
| 2023 Novembro | 52 | 34 | 86 |
| 2023 Outubro | 32 | 22 | 54 |
| 2023 Setembro | 43 | 22 | 65 |
| 2023 Agosto | 52 | 27 | 79 |
| 2023 Julho | 34 | 8 | 42 |
| 2023 Junho | 42 | 19 | 61 |
| 2023 Maio | 65 | 30 | 95 |
| 2023 Abril | 38 | 1 | 39 |
| 2023 Maro | 63 | 22 | 85 |
| 2023 Fevereiro | 44 | 24 | 68 |
| 2023 Janeiro | 36 | 12 | 48 |
| 2022 Dezembro | 41 | 25 | 66 |
| 2022 Novembro | 51 | 36 | 87 |
| 2022 Outubro | 61 | 23 | 84 |
| 2022 Setembro | 36 | 32 | 68 |
| 2022 Agosto | 43 | 38 | 81 |
| 2022 Julho | 44 | 39 | 83 |
| 2022 Junho | 49 | 25 | 74 |
| 2022 Maio | 34 | 30 | 64 |
| 2022 Abril | 46 | 36 | 82 |
| 2022 Maro | 39 | 46 | 85 |
| 2022 Fevereiro | 30 | 37 | 67 |
| 2022 Janeiro | 55 | 39 | 94 |
| 2021 Dezembro | 41 | 31 | 72 |
| 2021 Novembro | 32 | 36 | 68 |
| 2021 Outubro | 47 | 43 | 90 |
| 2021 Setembro | 38 | 35 | 73 |
| 2021 Agosto | 44 | 33 | 77 |
| 2021 Julho | 36 | 19 | 55 |
| 2021 Junho | 41 | 36 | 77 |
| 2021 Maio | 36 | 36 | 72 |
| 2021 Abril | 58 | 13 | 71 |
| 2021 Maro | 51 | 26 | 77 |
| 2021 Fevereiro | 41 | 21 | 62 |
| 2021 Janeiro | 42 | 15 | 57 |
| 2020 Dezembro | 37 | 15 | 52 |
| 2020 Novembro | 28 | 23 | 51 |
| 2020 Outubro | 40 | 15 | 55 |
| 2020 Setembro | 71 | 36 | 107 |
| 2020 Agosto | 40 | 6 | 46 |
| 2020 Julho | 32 | 21 | 53 |
| 2020 Junho | 26 | 16 | 42 |
| 2020 Maio | 34 | 11 | 45 |
| 2020 Abril | 37 | 21 | 58 |
| 2020 Maro | 39 | 17 | 56 |
| 2020 Fevereiro | 160 | 32 | 192 |
| 2020 Janeiro | 23 | 16 | 39 |
| 2019 Dezembro | 32 | 8 | 40 |
| 2019 Novembro | 25 | 6 | 31 |
| 2019 Outubro | 19 | 13 | 32 |
| 2019 Setembro | 59 | 8 | 67 |
| 2019 Agosto | 20 | 11 | 31 |
| 2019 Julho | 31 | 25 | 56 |
| 2019 Junho | 39 | 14 | 53 |
| 2019 Maio | 43 | 19 | 62 |
| 2019 Abril | 27 | 16 | 43 |
| 2019 Maro | 30 | 17 | 47 |
| 2019 Fevereiro | 29 | 14 | 43 |
| 2019 Janeiro | 52 | 21 | 73 |
| 2018 Dezembro | 38 | 39 | 77 |
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