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
Corresponding author
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/S2174204918304252?idApp=UINPBA00004E" "url" => "/21742049/0000003700000012/v1_201812280741/S2174204918304252/v1_201812280741/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" => "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>" ] ] ] "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" => "xres1131837" "titulo" => "Abstract" "secciones" => array:1 [ 0 => array:1 [ "identificador" => "abst0005" ] ] ] 1 => array:2 [ "identificador" => "xpalclavsec1064501" "titulo" => "Keywords" ] 2 => array:3 [ "identificador" => "xres1131836" "titulo" => "Resumo" "secciones" => array:1 [ 0 => array:1 [ "identificador" => "abst0010" ] ] ] 3 => array:2 [ "identificador" => "xpalclavsec1064502" "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" => "xpalclavsec1064501" "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" => "xpalclavsec1064502" "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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| Year/Month | Html | Total | |
|---|---|---|---|
| 2024 November | 6 | 3 | 9 |
| 2024 October | 37 | 34 | 71 |
| 2024 September | 36 | 33 | 69 |
| 2024 August | 31 | 21 | 52 |
| 2024 July | 26 | 27 | 53 |
| 2024 June | 23 | 19 | 42 |
| 2024 May | 26 | 25 | 51 |
| 2024 April | 21 | 23 | 44 |
| 2024 March | 25 | 29 | 54 |
| 2024 February | 18 | 25 | 43 |
| 2024 January | 28 | 24 | 52 |
| 2023 December | 21 | 25 | 46 |
| 2023 November | 37 | 38 | 75 |
| 2023 October | 30 | 10 | 40 |
| 2023 September | 43 | 20 | 63 |
| 2023 August | 24 | 19 | 43 |
| 2023 July | 36 | 8 | 44 |
| 2023 June | 37 | 17 | 54 |
| 2023 May | 40 | 33 | 73 |
| 2023 April | 34 | 9 | 43 |
| 2023 March | 47 | 24 | 71 |
| 2023 February | 40 | 16 | 56 |
| 2023 January | 46 | 29 | 75 |
| 2022 December | 49 | 32 | 81 |
| 2022 November | 42 | 27 | 69 |
| 2022 October | 42 | 30 | 72 |
| 2022 September | 29 | 39 | 68 |
| 2022 August | 39 | 28 | 67 |
| 2022 July | 28 | 36 | 64 |
| 2022 June | 29 | 20 | 49 |
| 2022 May | 24 | 25 | 49 |
| 2022 April | 39 | 36 | 75 |
| 2022 March | 30 | 58 | 88 |
| 2022 February | 41 | 37 | 78 |
| 2022 January | 33 | 32 | 65 |
| 2021 December | 19 | 36 | 55 |
| 2021 November | 22 | 30 | 52 |
| 2021 October | 31 | 42 | 73 |
| 2021 September | 24 | 25 | 49 |
| 2021 August | 33 | 29 | 62 |
| 2021 July | 23 | 22 | 45 |
| 2021 June | 12 | 15 | 27 |
| 2021 May | 35 | 36 | 71 |
| 2021 April | 26 | 43 | 69 |
| 2021 March | 28 | 15 | 43 |
| 2021 February | 28 | 16 | 44 |
| 2021 January | 28 | 14 | 42 |
| 2020 December | 24 | 12 | 36 |
| 2020 November | 17 | 13 | 30 |
| 2020 October | 6 | 8 | 14 |
| 2020 September | 19 | 12 | 31 |
| 2020 August | 13 | 8 | 21 |
| 2020 July | 10 | 9 | 19 |
| 2020 June | 18 | 11 | 29 |
| 2020 May | 13 | 6 | 19 |
| 2020 April | 17 | 12 | 29 |
| 2020 March | 15 | 7 | 22 |
| 2020 February | 16 | 14 | 30 |
| 2020 January | 10 | 7 | 17 |
| 2019 December | 10 | 5 | 15 |
| 2019 November | 15 | 10 | 25 |
| 2019 October | 7 | 7 | 14 |
| 2019 September | 49 | 6 | 55 |
| 2019 August | 13 | 8 | 21 |
| 2019 July | 10 | 9 | 19 |
| 2019 June | 14 | 18 | 32 |
| 2019 May | 20 | 11 | 31 |
| 2019 April | 17 | 23 | 40 |
| 2019 March | 10 | 13 | 23 |
| 2019 February | 20 | 13 | 33 |
| 2019 January | 32 | 13 | 45 |
| 2018 December | 6 | 8 | 14 |
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