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Magmaris resorbable magnesium scaffolds: Are they here to stay?
Suporte vascular restaurativo transitório coronário de magnésio – Magmaris: Veio para ficar?
Juan Ramon Jimenez University Hospital, Huelva, Spain
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"tieneTextoCompleto" => true "paginas" => array:1 [ 0 => array:2 [ "paginaInicial" => "427" "paginaFinal" => "429" ] ] "autores" => array:1 [ 0 => array:4 [ "autoresLista" => "José F. Díaz, Santiago Camacho" "autores" => array:2 [ 0 => array:4 [ "nombre" => "José F." "apellidos" => "Díaz" "email" => array:1 [ 0 => "jfdiazf@yahoo.es" ] "referencia" => array:1 [ 0 => array:2 [ "etiqueta" => "<span class="elsevierStyleSup">*</span>" "identificador" => "cor0005" ] ] ] 1 => array:2 [ "nombre" => "Santiago" "apellidos" => "Camacho" ] ] "afiliaciones" => array:1 [ 0 => array:2 [ "entidad" => "Juan Ramon Jimenez University Hospital, Huelva, Spain" "identificador" => "aff0005" ] ] "correspondencia" => array:1 [ 0 => array:3 [ "identificador" => "cor0005" "etiqueta" => "⁎" "correspondencia" => "Corresponding author." ] ] ] ] "titulosAlternativos" => array:1 [ "pt" => array:1 [ "titulo" => "Suporte vascular restaurativo transitório coronário de magnésio – Magmaris: <span class="elsevierStyleItalic">Veio para ficar</span>?" ] ] "textoCompleto" => "<span class="elsevierStyleSections"><p id="par0005" class="elsevierStylePara elsevierViewall">The introduction of drug-eluting stents (DES) in 2002 was considered to be the third revolution in interventional cardiology, after the first one, balloon angioplasty and the second, bare metal stents (BMS). DES were primarily designed to overcome the main drawback of BMS: the occurrence of in-stent restenosis due to intimal hyperplasia and its proof of concept was the publication of the RAVEL trial.<a class="elsevierStyleCrossRef" href="#bib0075"><span class="elsevierStyleSup">1</span></a> Shortly aftewards, both large scale randomized trials and all-comer registries showed excellent results in terms of the need for repeat revascularization. However, after the enthusiasm that followed these initial results, later registries of all-comers treated with first generation DES showed late stent thrombosis rates of 0.53% per year, which continued increase to 3% over four years.<a class="elsevierStyleCrossRef" href="#bib0080"><span class="elsevierStyleSup">2</span></a></p><p id="par0010" class="elsevierStylePara elsevierViewall">Over the past decade, in efforts to improve safety and efficacy, several second and even third generation DES have been developed with different alloys, polymers, and antiproliferative drugs. These refinements have confirmed DES as superior to BMS in terms of safety and efficacy.<a class="elsevierStyleCrossRef" href="#bib0085"><span class="elsevierStyleSup">3</span></a> On the other hand, evidence suggests that permanent metallic coronary stents may alter flow dynamics, abolish vascular reactivity and limit the potential for maximal vasodilation.<a class="elsevierStyleCrossRef" href="#bib0090"><span class="elsevierStyleSup">4</span></a></p><p id="par0015" class="elsevierStylePara elsevierViewall">In any case, the concept of a fully resorbable stent-like device has always been very attractive to the interventional community; such a device could offer transient radial strength to resist acute vessel recoil, and at a later stage would be fully resorbed, leading to restoration of the vessel's biological properties. This would make the device one of the holy grails of interventional cardiology.</p><p id="par0020" class="elsevierStylePara elsevierViewall">In 2008, what has been called the fourth revolution in interventional cardiology came about the advent of the first CE mark approved bioabsorbable platform, ABSORB (Abbott Vascular, Santa Clara, CA, USA). The feasibility and clinical safety of the first generation ABSORB was proven by the ABSORB Cohort A trial in 30 low risk patients with coronary artery disease. A reported incidence of major adverse cardiac events of 3.4% at four-year follow up was observed, with no episodes of stent thrombosis.<a class="elsevierStyleCrossRef" href="#bib0095"><span class="elsevierStyleSup">5</span></a></p><p id="par0025" class="elsevierStylePara elsevierViewall">However, the inclusion of increasingly more complex patients in studies and registries has shown a suboptimal rate of events with ABSORB, raising concerns mainly with regard to scaffold thrombosis.<a class="elsevierStyleCrossRef" href="#bib0100"><span class="elsevierStyleSup">6</span></a></p><p id="par0030" class="elsevierStylePara elsevierViewall">Bioabsorbable metallic scaffolds, which are intuitively an attractive option because their mechanical performance is similar to that of metal stents, are an alternative to polymeric scaffolds.<a class="elsevierStyleCrossRef" href="#bib0105"><span class="elsevierStyleSup">7</span></a> PROGRESS AMS was the first-in-man trial of an absorbable metal stent (magnesium alloy) in coronary arteries. Results showed that the device had a good safety profile, with no deaths, myocardial infarction, or scaffold thrombosis reported. In-scaffold acute gain was promising, but in-scaffold late lumen loss and ischemia-driven target lesion revascularization (TLR) were high at four months because of negative remodeling and neointimal proliferation, suggesting the need for slower scaffold absorption and antiproliferative drug elution.<a class="elsevierStyleCrossRef" href="#bib0110"><span class="elsevierStyleSup">8</span></a></p><p id="par0035" class="elsevierStylePara elsevierViewall">Several modifications were made to the original platform giving rise to DREAMS 1-G, which included a modified magnesium alloy and the addition of paclitaxel; a further evolution with sirolimus elution, DREAMS 2-G, commercially known as MAGMARIS (Biotronik, Berlin, Germany) was finally launched.</p><p id="par0040" class="elsevierStylePara elsevierViewall">The BIOSOLVE Clinical Program was set up to assess the clinical efficacy and safety of Magmaris in four multicenter studies, totaling more than 1500 patients.</p><p id="par0045" class="elsevierStylePara elsevierViewall">BIOSOLVE I was a prospective, multicenter, first-in-man trial designed to assess the safety and performance of the paclitaxel-eluting DREAMS scaffold.<a class="elsevierStyleCrossRef" href="#bib0115"><span class="elsevierStyleSup">9</span></a> In a population of 46 patients with simple lesions, the resorbable device showed a target lesion failure (TLF) rate of 6.6%, with no cases of scaffold thrombosis.</p><p id="par0050" class="elsevierStylePara elsevierViewall">Data from BIOSOLVE II and BIOSOLVE-III were pooled and published together.<a class="elsevierStyleCrossRefs" href="#bib0120"><span class="elsevierStyleSup">10,11</span></a> BIOSOLVE II was a prospective, international, multi-center, first-in-man trial using the second-generation drug-eluting absorbable metal scaffold Magmaris. Twelve-month in-segment late lumen loss (LLL) was 0.39±0.27 mm, superior to the LLL described with the previous iteration of the absorbable metal scaffold.<a class="elsevierStyleCrossRef" href="#bib0115"><span class="elsevierStyleSup">9</span></a> TLF was reported in four patients (3.4%) at 12 months, again with no cases of scaffold thrombosis. At 24 months the combined rate of TLF in both studies was 5.9% and no definite or probable scaffold thrombosis was reported.<a class="elsevierStyleCrossRef" href="#bib0125"><span class="elsevierStyleSup">11</span></a></p><p id="par0055" class="elsevierStylePara elsevierViewall">Finally, BIOSOLVE-IV is an international, single-arm, multicenter registry conducted at 86 centers.<a class="elsevierStyleCrossRef" href="#bib0130"><span class="elsevierStyleSup">12</span></a> Among the first 400 patients included, procedure and device success was high (98.5% and 96.1%, respectively) in this more complex population of patients. Only one case of scaffold thrombosis was found (0.3%) and TLF at 12 months was 4.3%.</p><p id="par0060" class="elsevierStylePara elsevierViewall">In this issue of the Portuguese Journal of Cardiology, Abellas et al.<a class="elsevierStyleCrossRef" href="#bib0135"><span class="elsevierStyleSup">13</span></a> present their experience with Magmaris in a population of 42 real-world patients. In this single-center registry, the strategy of the 4Ps (patient selection, proper sizing, predilatation and post-dilatation) was followed scrupulously in all cases. At 12 months, TLF was 4.7%, corresponding to two cases of clinically driven TLR, with no cases of scaffold thrombosis. The authors emphasize the need for an adequate selection of patients, especially the absence of calcium, in order to achieve these excellent outcomes.</p><p id="par0065" class="elsevierStylePara elsevierViewall">These results corroborate those from BIOSOLVE II, III and IV,<a class="elsevierStyleCrossRefs" href="#bib0120"><span class="elsevierStyleSup">10–12</span></a> with very similar TLF rates and, more importantly, no cases of scaffold thrombosis in spite of 54.7% of patients presenting with acute coronary syndromes.</p><p id="par0070" class="elsevierStylePara elsevierViewall">The only publication with Magmaris in an acute setting to date is the MAGSTEMI trial, which randomized 150 ST-elevation myocardial infarction patients to Magmaris or a sirolimus-eluting DES. At 12 months, a better vasomotor response was found in patients treated with Magmaris (primary endpoint), although TLR was significantly higher in the Magmaris group (16.2% vs. 5.2%, p=0.03). Only one case of ST occurred in the Magmaris group versus two cases in the DES group.<a class="elsevierStyleCrossRef" href="#bib0140"><span class="elsevierStyleSup">14</span></a></p><p id="par0075" class="elsevierStylePara elsevierViewall">In summary, with an adequate selection of patients and technique, safety with Magmaris does not seem to be a major issue, while efficacy will need to be assessed in further randomized trials, probably compared with a state-of-the-art DES.</p><p id="par0080" class="elsevierStylePara elsevierViewall">In conclusion, despite the compelling evidence of metallic DES efficacy in a large proportion of patients, important limitations remain such as hypersensitivity reactions, late stent thrombosis, and neoatherosclerotic stent failure. Further improvements in the magnesium scaffold device characteristics in newer generations could help resolve these issues.</p><p id="par0085" class="elsevierStylePara elsevierViewall">In the meantime, it seems clear that Magmaris is here to stay.</p><span id="sec0005" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0005">Conflicts of interest</span><p id="par0090" class="elsevierStylePara elsevierViewall">The authors have no conflicts of interest to declare.</p></span></span>" "textoCompletoSecciones" => array:1 [ "secciones" => array:2 [ 0 => array:2 [ "identificador" => "sec0005" "titulo" => "Conflicts of interest" ] 1 => array:1 [ "titulo" => "References" ] ] ] "pdfFichero" => "main.pdf" "tienePdf" => true "bibliografia" => array:2 [ "titulo" => "References" "seccion" => array:1 [ 0 => array:2 [ "identificador" => "bibs0015" "bibliografiaReferencia" => array:14 [ 0 => array:3 [ "identificador" => "bib0075" "etiqueta" => "1" "referencia" => array:1 [ 0 => array:2 [ "contribucion" => array:1 [ 0 => array:2 [ "titulo" => "A randomized comparison of a sirolimus-eluting stent with a standard stent for coronary revascularization" "autores" => array:1 [ 0 => array:2 [ "etal" => true "autores" => array:3 [ 0 => "M.C. 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| Year/Month | Html | Total | |
|---|---|---|---|
| 2024 November | 7 | 4 | 11 |
| 2024 October | 117 | 36 | 153 |
| 2024 September | 55 | 31 | 86 |
| 2024 August | 38 | 34 | 72 |
| 2024 July | 32 | 31 | 63 |
| 2024 June | 34 | 24 | 58 |
| 2024 May | 38 | 21 | 59 |
| 2024 April | 49 | 26 | 75 |
| 2024 March | 30 | 22 | 52 |
| 2024 February | 33 | 22 | 55 |
| 2024 January | 25 | 35 | 60 |
| 2023 December | 32 | 25 | 57 |
| 2023 November | 36 | 38 | 74 |
| 2023 October | 30 | 19 | 49 |
| 2023 September | 33 | 23 | 56 |
| 2023 August | 39 | 17 | 56 |
| 2023 July | 24 | 9 | 33 |
| 2023 June | 31 | 15 | 46 |
| 2023 May | 47 | 34 | 81 |
| 2023 April | 37 | 7 | 44 |
| 2023 March | 41 | 22 | 63 |
| 2023 February | 32 | 16 | 48 |
| 2023 January | 15 | 14 | 29 |
| 2022 December | 49 | 29 | 78 |
| 2022 November | 37 | 32 | 69 |
| 2022 October | 43 | 27 | 70 |
| 2022 September | 29 | 38 | 67 |
| 2022 August | 22 | 27 | 49 |
| 2022 July | 30 | 45 | 75 |
| 2022 June | 18 | 24 | 42 |
| 2022 May | 21 | 27 | 48 |
| 2022 April | 28 | 34 | 62 |
| 2022 March | 27 | 52 | 79 |
| 2022 February | 24 | 43 | 67 |
| 2022 January | 17 | 37 | 54 |
| 2021 December | 21 | 32 | 53 |
| 2021 November | 23 | 32 | 55 |
| 2021 October | 35 | 38 | 73 |
| 2021 September | 21 | 17 | 38 |
| 2021 August | 20 | 26 | 46 |
| 2021 July | 15 | 19 | 34 |
| 2021 June | 20 | 20 | 40 |
| 2021 May | 23 | 36 | 59 |
| 2021 April | 41 | 76 | 117 |
| 2021 March | 60 | 13 | 73 |
| 2021 February | 21 | 11 | 32 |
| 2021 January | 45 | 16 | 61 |
| 2020 December | 20 | 11 | 31 |
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