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    "textoCompleto" => "<span class="elsevierStyleSections"><p id="par0005" class="elsevierStylePara elsevierViewall">The introduction of drug-eluting stents &#40;DES&#41; in 2002 was considered to be the third revolution in interventional cardiology&#44; after the first one&#44; balloon angioplasty and the second&#44; bare metal stents &#40;BMS&#41;&#46; DES were primarily designed to overcome the main drawback of BMS&#58; the occurrence of in-stent restenosis due to intimal hyperplasia and its proof of concept was the publication of the RAVEL trial&#46;<a class="elsevierStyleCrossRef" href="#bib0075"><span class="elsevierStyleSup">1</span></a> Shortly aftewards&#44; both large scale randomized trials and all-comer registries showed excellent results in terms of the need for repeat revascularization&#46; However&#44; after the enthusiasm that followed these initial results&#44; later registries of all-comers treated with first generation DES showed late stent thrombosis rates of 0&#46;53&#37; per year&#44; which continued increase to 3&#37; over four years&#46;<a class="elsevierStyleCrossRef" href="#bib0080"><span class="elsevierStyleSup">2</span></a></p><p id="par0010" class="elsevierStylePara elsevierViewall">Over the past decade&#44; in efforts to improve safety and efficacy&#44; several second and even third generation DES have been developed with different alloys&#44; polymers&#44; and antiproliferative drugs&#46; These refinements have confirmed DES as superior to BMS in terms of safety and efficacy&#46;<a class="elsevierStyleCrossRef" href="#bib0085"><span class="elsevierStyleSup">3</span></a> On the other hand&#44; evidence suggests that permanent metallic coronary stents may alter flow dynamics&#44; abolish vascular reactivity and limit the potential for maximal vasodilation&#46;<a class="elsevierStyleCrossRef" href="#bib0090"><span class="elsevierStyleSup">4</span></a></p><p id="par0015" class="elsevierStylePara elsevierViewall">In any case&#44; the concept of a fully resorbable stent-like device has always been very attractive to the interventional community&#59; such a device could offer transient radial strength to resist acute vessel recoil&#44; and at a later stage would be fully resorbed&#44; leading to restoration of the vessel&#39;s biological properties&#46; This would make the device one of the holy grails of interventional cardiology&#46;</p><p id="par0020" class="elsevierStylePara elsevierViewall">In 2008&#44; what has been called the fourth revolution in interventional cardiology came about the advent of the first CE mark approved bioabsorbable platform&#44; ABSORB &#40;Abbott Vascular&#44; Santa Clara&#44; CA&#44; USA&#41;&#46; 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&#46; A reported incidence of major adverse cardiac events of 3&#46;4&#37; at four-year follow up was observed&#44; with no episodes of stent thrombosis&#46;<a class="elsevierStyleCrossRef" href="#bib0095"><span class="elsevierStyleSup">5</span></a></p><p id="par0025" class="elsevierStylePara elsevierViewall">However&#44; the inclusion of increasingly more complex patients in studies and registries has shown a suboptimal rate of events with ABSORB&#44; raising concerns mainly with regard to scaffold thrombosis&#46;<a class="elsevierStyleCrossRef" href="#bib0100"><span class="elsevierStyleSup">6</span></a></p><p id="par0030" class="elsevierStylePara elsevierViewall">Bioabsorbable metallic scaffolds&#44; which are intuitively an attractive option because their mechanical performance is similar to that of metal stents&#44; are an alternative to polymeric scaffolds&#46;<a class="elsevierStyleCrossRef" href="#bib0105"><span class="elsevierStyleSup">7</span></a> PROGRESS AMS was the first-in-man trial of an absorbable metal stent &#40;magnesium alloy&#41; in coronary arteries&#46; Results showed that the device had a good safety profile&#44; with no deaths&#44; myocardial infarction&#44; or scaffold thrombosis reported&#46; In-scaffold acute gain was promising&#44; but in-scaffold late lumen loss and ischemia-driven target lesion revascularization &#40;TLR&#41; were high at four months because of negative remodeling and neointimal proliferation&#44; suggesting the need for slower scaffold absorption and antiproliferative drug elution&#46;<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&#44; which included a modified magnesium alloy and the addition of paclitaxel&#59; a further evolution with sirolimus elution&#44; DREAMS 2-G&#44; commercially known as MAGMARIS &#40;Biotronik&#44; Berlin&#44; Germany&#41; was finally launched&#46;</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&#44; totaling more than 1500 patients&#46;</p><p id="par0045" class="elsevierStylePara elsevierViewall">BIOSOLVE I was a prospective&#44; multicenter&#44; first-in-man trial designed to assess the safety and performance of the paclitaxel-eluting DREAMS scaffold&#46;<a class="elsevierStyleCrossRef" href="#bib0115"><span class="elsevierStyleSup">9</span></a> In a population of 46 patients with simple lesions&#44; the resorbable device showed a target lesion failure &#40;TLF&#41; rate of 6&#46;6&#37;&#44; with no cases of scaffold thrombosis&#46;</p><p id="par0050" class="elsevierStylePara elsevierViewall">Data from BIOSOLVE II and BIOSOLVE-III were pooled and published together&#46;<a class="elsevierStyleCrossRefs" href="#bib0120"><span class="elsevierStyleSup">10&#44;11</span></a> BIOSOLVE II was a prospective&#44; international&#44; multi-center&#44; first-in-man trial using the second-generation drug-eluting absorbable metal scaffold Magmaris&#46; Twelve-month in-segment late lumen loss &#40;LLL&#41; was 0&#46;39&#177;0&#46;27 mm&#44; superior to the LLL described with the previous iteration of the absorbable metal scaffold&#46;<a class="elsevierStyleCrossRef" href="#bib0115"><span class="elsevierStyleSup">9</span></a> TLF was reported in four patients &#40;3&#46;4&#37;&#41; at 12 months&#44; again with no cases of scaffold thrombosis&#46; At 24 months the combined rate of TLF in both studies was 5&#46;9&#37; and no definite or probable scaffold thrombosis was reported&#46;<a class="elsevierStyleCrossRef" href="#bib0125"><span class="elsevierStyleSup">11</span></a></p><p id="par0055" class="elsevierStylePara elsevierViewall">Finally&#44; BIOSOLVE-IV is an international&#44; single-arm&#44; multicenter registry conducted at 86 centers&#46;<a class="elsevierStyleCrossRef" href="#bib0130"><span class="elsevierStyleSup">12</span></a> Among the first 400 patients included&#44; procedure and device success was high &#40;98&#46;5&#37; and 96&#46;1&#37;&#44; respectively&#41; in this more complex population of patients&#46; Only one case of scaffold thrombosis was found &#40;0&#46;3&#37;&#41; and TLF at 12 months was 4&#46;3&#37;&#46;</p><p id="par0060" class="elsevierStylePara elsevierViewall">In this issue of the Portuguese Journal of Cardiology&#44; Abellas et al&#46;<a class="elsevierStyleCrossRef" href="#bib0135"><span class="elsevierStyleSup">13</span></a> present their experience with Magmaris in a population of 42 real-world patients&#46; In this single-center registry&#44; the strategy of the 4Ps &#40;patient selection&#44; proper sizing&#44; predilatation and post-dilatation&#41; was followed scrupulously in all cases&#46; At 12 months&#44; TLF was 4&#46;7&#37;&#44; corresponding to two cases of clinically driven TLR&#44; with no cases of scaffold thrombosis&#46; The authors emphasize the need for an adequate selection of patients&#44; especially the absence of calcium&#44; in order to achieve these excellent outcomes&#46;</p><p id="par0065" class="elsevierStylePara elsevierViewall">These results corroborate those from BIOSOLVE II&#44; III and IV&#44;<a class="elsevierStyleCrossRefs" href="#bib0120"><span class="elsevierStyleSup">10&#8211;12</span></a> with very similar TLF rates and&#44; more importantly&#44; no cases of scaffold thrombosis in spite of 54&#46;7&#37; of patients presenting with acute coronary syndromes&#46;</p><p id="par0070" class="elsevierStylePara elsevierViewall">The only publication with Magmaris in an acute setting to date is the MAGSTEMI trial&#44; which randomized 150 ST-elevation myocardial infarction&#160;patients to Magmaris or a sirolimus-eluting DES&#46; At 12 months&#44; a better vasomotor response was found in patients treated with Magmaris &#40;primary endpoint&#41;&#44; although TLR was significantly higher in the Magmaris group &#40;16&#46;2&#37; vs&#46; 5&#46;2&#37;&#44; p&#61;0&#46;03&#41;&#46; Only one case of ST occurred in the Magmaris group versus two cases in the DES group&#46;<a class="elsevierStyleCrossRef" href="#bib0140"><span class="elsevierStyleSup">14</span></a></p><p id="par0075" class="elsevierStylePara elsevierViewall">In summary&#44; with an adequate selection of patients and technique&#44; safety with Magmaris does not seem to be a major issue&#44; while efficacy will need to be assessed in further randomized trials&#44; probably compared with a state-of-the-art DES&#46;</p><p id="par0080" class="elsevierStylePara elsevierViewall">In conclusion&#44; despite the compelling evidence of metallic DES efficacy in a large proportion of patients&#44; important limitations remain such as hypersensitivity reactions&#44; late stent thrombosis&#44; and neoatherosclerotic stent failure&#46; Further improvements in the magnesium scaffold device characteristics in newer generations could help resolve these issues&#46;</p><p id="par0085" class="elsevierStylePara elsevierViewall">In the meantime&#44; it seems clear that Magmaris is here to stay&#46;</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&#46;</p></span></span>"
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Editorial comment
Magmaris resorbable magnesium scaffolds: Are they here to stay?
Suporte vascular restaurativo transitório coronário de magnésio – Magmaris: Veio para ficar?
José F. Díaz
Autor para correspondência
jfdiazf@yahoo.es

Corresponding author.
, Santiago Camacho
Juan Ramon Jimenez University Hospital, Huelva, Spain
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    "textoCompleto" => "<span class="elsevierStyleSections"><p id="par0005" class="elsevierStylePara elsevierViewall">The introduction of drug-eluting stents &#40;DES&#41; in 2002 was considered to be the third revolution in interventional cardiology&#44; after the first one&#44; balloon angioplasty and the second&#44; bare metal stents &#40;BMS&#41;&#46; DES were primarily designed to overcome the main drawback of BMS&#58; the occurrence of in-stent restenosis due to intimal hyperplasia and its proof of concept was the publication of the RAVEL trial&#46;<a class="elsevierStyleCrossRef" href="#bib0075"><span class="elsevierStyleSup">1</span></a> Shortly aftewards&#44; both large scale randomized trials and all-comer registries showed excellent results in terms of the need for repeat revascularization&#46; However&#44; after the enthusiasm that followed these initial results&#44; later registries of all-comers treated with first generation DES showed late stent thrombosis rates of 0&#46;53&#37; per year&#44; which continued increase to 3&#37; over four years&#46;<a class="elsevierStyleCrossRef" href="#bib0080"><span class="elsevierStyleSup">2</span></a></p><p id="par0010" class="elsevierStylePara elsevierViewall">Over the past decade&#44; in efforts to improve safety and efficacy&#44; several second and even third generation DES have been developed with different alloys&#44; polymers&#44; and antiproliferative drugs&#46; These refinements have confirmed DES as superior to BMS in terms of safety and efficacy&#46;<a class="elsevierStyleCrossRef" href="#bib0085"><span class="elsevierStyleSup">3</span></a> On the other hand&#44; evidence suggests that permanent metallic coronary stents may alter flow dynamics&#44; abolish vascular reactivity and limit the potential for maximal vasodilation&#46;<a class="elsevierStyleCrossRef" href="#bib0090"><span class="elsevierStyleSup">4</span></a></p><p id="par0015" class="elsevierStylePara elsevierViewall">In any case&#44; the concept of a fully resorbable stent-like device has always been very attractive to the interventional community&#59; such a device could offer transient radial strength to resist acute vessel recoil&#44; and at a later stage would be fully resorbed&#44; leading to restoration of the vessel&#39;s biological properties&#46; This would make the device one of the holy grails of interventional cardiology&#46;</p><p id="par0020" class="elsevierStylePara elsevierViewall">In 2008&#44; what has been called the fourth revolution in interventional cardiology came about the advent of the first CE mark approved bioabsorbable platform&#44; ABSORB &#40;Abbott Vascular&#44; Santa Clara&#44; CA&#44; USA&#41;&#46; 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&#46; A reported incidence of major adverse cardiac events of 3&#46;4&#37; at four-year follow up was observed&#44; with no episodes of stent thrombosis&#46;<a class="elsevierStyleCrossRef" href="#bib0095"><span class="elsevierStyleSup">5</span></a></p><p id="par0025" class="elsevierStylePara elsevierViewall">However&#44; the inclusion of increasingly more complex patients in studies and registries has shown a suboptimal rate of events with ABSORB&#44; raising concerns mainly with regard to scaffold thrombosis&#46;<a class="elsevierStyleCrossRef" href="#bib0100"><span class="elsevierStyleSup">6</span></a></p><p id="par0030" class="elsevierStylePara elsevierViewall">Bioabsorbable metallic scaffolds&#44; which are intuitively an attractive option because their mechanical performance is similar to that of metal stents&#44; are an alternative to polymeric scaffolds&#46;<a class="elsevierStyleCrossRef" href="#bib0105"><span class="elsevierStyleSup">7</span></a> PROGRESS AMS was the first-in-man trial of an absorbable metal stent &#40;magnesium alloy&#41; in coronary arteries&#46; Results showed that the device had a good safety profile&#44; with no deaths&#44; myocardial infarction&#44; or scaffold thrombosis reported&#46; In-scaffold acute gain was promising&#44; but in-scaffold late lumen loss and ischemia-driven target lesion revascularization &#40;TLR&#41; were high at four months because of negative remodeling and neointimal proliferation&#44; suggesting the need for slower scaffold absorption and antiproliferative drug elution&#46;<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&#44; which included a modified magnesium alloy and the addition of paclitaxel&#59; a further evolution with sirolimus elution&#44; DREAMS 2-G&#44; commercially known as MAGMARIS &#40;Biotronik&#44; Berlin&#44; Germany&#41; was finally launched&#46;</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&#44; totaling more than 1500 patients&#46;</p><p id="par0045" class="elsevierStylePara elsevierViewall">BIOSOLVE I was a prospective&#44; multicenter&#44; first-in-man trial designed to assess the safety and performance of the paclitaxel-eluting DREAMS scaffold&#46;<a class="elsevierStyleCrossRef" href="#bib0115"><span class="elsevierStyleSup">9</span></a> In a population of 46 patients with simple lesions&#44; the resorbable device showed a target lesion failure &#40;TLF&#41; rate of 6&#46;6&#37;&#44; with no cases of scaffold thrombosis&#46;</p><p id="par0050" class="elsevierStylePara elsevierViewall">Data from BIOSOLVE II and BIOSOLVE-III were pooled and published together&#46;<a class="elsevierStyleCrossRefs" href="#bib0120"><span class="elsevierStyleSup">10&#44;11</span></a> BIOSOLVE II was a prospective&#44; international&#44; multi-center&#44; first-in-man trial using the second-generation drug-eluting absorbable metal scaffold Magmaris&#46; Twelve-month in-segment late lumen loss &#40;LLL&#41; was 0&#46;39&#177;0&#46;27 mm&#44; superior to the LLL described with the previous iteration of the absorbable metal scaffold&#46;<a class="elsevierStyleCrossRef" href="#bib0115"><span class="elsevierStyleSup">9</span></a> TLF was reported in four patients &#40;3&#46;4&#37;&#41; at 12 months&#44; again with no cases of scaffold thrombosis&#46; At 24 months the combined rate of TLF in both studies was 5&#46;9&#37; and no definite or probable scaffold thrombosis was reported&#46;<a class="elsevierStyleCrossRef" href="#bib0125"><span class="elsevierStyleSup">11</span></a></p><p id="par0055" class="elsevierStylePara elsevierViewall">Finally&#44; BIOSOLVE-IV is an international&#44; single-arm&#44; multicenter registry conducted at 86 centers&#46;<a class="elsevierStyleCrossRef" href="#bib0130"><span class="elsevierStyleSup">12</span></a> Among the first 400 patients included&#44; procedure and device success was high &#40;98&#46;5&#37; and 96&#46;1&#37;&#44; respectively&#41; in this more complex population of patients&#46; Only one case of scaffold thrombosis was found &#40;0&#46;3&#37;&#41; and TLF at 12 months was 4&#46;3&#37;&#46;</p><p id="par0060" class="elsevierStylePara elsevierViewall">In this issue of the Portuguese Journal of Cardiology&#44; Abellas et al&#46;<a class="elsevierStyleCrossRef" href="#bib0135"><span class="elsevierStyleSup">13</span></a> present their experience with Magmaris in a population of 42 real-world patients&#46; In this single-center registry&#44; the strategy of the 4Ps &#40;patient selection&#44; proper sizing&#44; predilatation and post-dilatation&#41; was followed scrupulously in all cases&#46; At 12 months&#44; TLF was 4&#46;7&#37;&#44; corresponding to two cases of clinically driven TLR&#44; with no cases of scaffold thrombosis&#46; The authors emphasize the need for an adequate selection of patients&#44; especially the absence of calcium&#44; in order to achieve these excellent outcomes&#46;</p><p id="par0065" class="elsevierStylePara elsevierViewall">These results corroborate those from BIOSOLVE II&#44; III and IV&#44;<a class="elsevierStyleCrossRefs" href="#bib0120"><span class="elsevierStyleSup">10&#8211;12</span></a> with very similar TLF rates and&#44; more importantly&#44; no cases of scaffold thrombosis in spite of 54&#46;7&#37; of patients presenting with acute coronary syndromes&#46;</p><p id="par0070" class="elsevierStylePara elsevierViewall">The only publication with Magmaris in an acute setting to date is the MAGSTEMI trial&#44; which randomized 150 ST-elevation myocardial infarction&#160;patients to Magmaris or a sirolimus-eluting DES&#46; At 12 months&#44; a better vasomotor response was found in patients treated with Magmaris &#40;primary endpoint&#41;&#44; although TLR was significantly higher in the Magmaris group &#40;16&#46;2&#37; vs&#46; 5&#46;2&#37;&#44; p&#61;0&#46;03&#41;&#46; Only one case of ST occurred in the Magmaris group versus two cases in the DES group&#46;<a class="elsevierStyleCrossRef" href="#bib0140"><span class="elsevierStyleSup">14</span></a></p><p id="par0075" class="elsevierStylePara elsevierViewall">In summary&#44; with an adequate selection of patients and technique&#44; safety with Magmaris does not seem to be a major issue&#44; while efficacy will need to be assessed in further randomized trials&#44; probably compared with a state-of-the-art DES&#46;</p><p id="par0080" class="elsevierStylePara elsevierViewall">In conclusion&#44; despite the compelling evidence of metallic DES efficacy in a large proportion of patients&#44; important limitations remain such as hypersensitivity reactions&#44; late stent thrombosis&#44; and neoatherosclerotic stent failure&#46; Further improvements in the magnesium scaffold device characteristics in newer generations could help resolve these issues&#46;</p><p id="par0085" class="elsevierStylePara elsevierViewall">In the meantime&#44; it seems clear that Magmaris is here to stay&#46;</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&#46;</p></span></span>"
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ISSN: 08702551
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