Rather Thick, Yet Antithrombogenic
2017; Lippincott Williams & Wilkins; Volume: 10; Issue: 8 Linguagem: Inglês
10.1161/circinterventions.117.005663
ISSN1941-7632
AutoresYoshinobu Onuma, Patrick W. Serruys,
Tópico(s)Cardiac Valve Diseases and Treatments
ResumoHomeCirculation: Cardiovascular InterventionsVol. 10, No. 8Rather Thick, Yet Antithrombogenic Free AccessEditorialPDF/EPUBAboutView PDFView EPUBSections ToolsAdd to favoritesDownload citationsTrack citationsPermissionsDownload Articles + Supplements ShareShare onFacebookTwitterLinked InMendeleyReddit Jump toSupplemental MaterialFree AccessEditorialPDF/EPUBRather Thick, Yet AntithrombogenicIs the Magmaris Scaffold a New Hope for Bioresorbable Coronary Scaffold? Yoshinobu Onuma, MD, PhD and Patrick W. Serruys, MD, PhD Yoshinobu OnumaYoshinobu Onuma From the Thoraxcenter, Erasmus Medical Center, Rotterdam, the Netherlands (Y.O.); Cardialysis BV, Rotterdam, the Netherlands (Y.O.); and International Centre for Circulatory Health, National Heart and Lung Institute, Imperial College London, United Kingdom (P.W.S.). and Patrick W. SerruysPatrick W. Serruys From the Thoraxcenter, Erasmus Medical Center, Rotterdam, the Netherlands (Y.O.); Cardialysis BV, Rotterdam, the Netherlands (Y.O.); and International Centre for Circulatory Health, National Heart and Lung Institute, Imperial College London, United Kingdom (P.W.S.). Originally published11 Aug 2017https://doi.org/10.1161/CIRCINTERVENTIONS.117.005663Circulation: Cardiovascular Interventions. 2017;10:e005663The concept of a fully bioresorbable coronary scaffold (BRS), a device that do its job and disappears, fits the physiological need to restore the coronary artery structure without implanting a permanent device, and the technology has, therefore, attracted interest of inventors, interventional community, and patients.1 BRS offers transient scaffolding of the vessel to prevent acute recoil and closure with an elution of antiproliferative drug to prevent constrictive remodeling and excessive neointimal hyperplasia. At long term, the disappearance of the device may allow the restoration of vasomotion and the mechanotransduction of cyclic strain to the coronary artery, which may influence the vessel wall metabolism and subsequent vascular remodeling.2 By eliminating the foreign body via bioresorption process, BRS maintains long-term suitability for future possible revascularization options (percutaneous or surgical), enables assessment of noninvasive imaging,3and potentially reduces long-term adverse events stemming from permanent materials.4See Article by Waksman et alAs of July 2017, 5 products—Absorb, Desolve, ART Pure, Magmaris, and Fantom scaffolds—acquired a Conformité Européene mark in Europe. The Absorb scaffold was the first device approved by Food and Drug Administration in the United States and by Pharmaceuticals and Medical Devices Agency in Japan.5 Three scaffolds (Absorb, Desolve, and ART Pure) were made of poly-lactide, whereas the Magmaris scaffold and the Fantom scaffold consisted of magnesium and thyrosine polycarbonate, respectively. To compensate inherent mechanical limitations of bioresorbable materials (lower tensile strength and shorter elongation-at-break), the struts of BRS are in general thicker (125–150 μm) and wider than those of permanent drug-eluting metallic stents.5Recent Setback of the Absorb ScaffoldDespite the initial expectation, the enthusiasm toward BRS has recently been ebbed away because of the worrisome signal of a higher thrombotic risk of the polymeric Absorb scaffold than the metallic Xience stent in both early and late/very late phase. Recent meta-analyses of randomized trials including the 2-year results of AIDA (Amsterdam Investigator-Initiated Absorb Strategy All-Comers Trial) and ABSORB III trials demonstrated that the risk of scaffold thrombosis increased by ≈2-folds for early phase6 and by ≈4-folds for very late phase (>1 year) in comparison with the Xience stent.7,8 After the publication of 2-year results of ABSORB III at the American College of Cardiology on March 18, 2017, the Food and Drug Administration issued a warning letter to healthcare providers to inform that there is an increased rate of major adverse cardiac events observed in patients receiving the BRS, when compared with patients treated with the approved metallic XIENCE drug-eluting stent (https://www.fda.gov/MedicalDevices/Safety/LetterstoHealthCareProviders/ucm546808.htm). Subsequently in Europe, the manufacturer (Abbott Vascular, Santa Clara, CA) restricted the use of Absorb only in clinical registry setting at selected sites since May 31, 2017 (https://www.tctmd.com/news/absorb-bvs-use-restricted-europe).Magmaris Magnesium ScaffoldMagnesium is considered as an attractive biodegradable material to create coronary BRS. Compared with poly-l-lactide or poly-d,l-lactide, magnesium has superior mechanical properties with its higher tensile strength and greater % elongation-at-break compared with the polymeric material.5 The magnesium alloy used in the Magmaris offers higher deformation resistance and lighter weight as compared with pure magnesium.9 Several elements, such as aluminum, calcium, manganese, rare earth elements, yttrium, zinc, and zirconium, can be combined with magnesium to modify the mechanical properties (eg, radial strength, hardness, etc.) and physical characteristics (eg, degradation speed) of the magnesium-based alloy.9The Magmaris magnesium BRS (Biotronik, Germany) received European Conformité Européene mark in May 2016 after the BIOSOLVE-II trial enrolling 123 patients. In a serial angiographic follow-up, 6- and 12-month angiographic in-scaffold late loss was 0.37±0.25 mm and 0.39±0.27 mm.10,11 More recently, in a pooled population of BIOSOLVE-II and BIOSOLVE-III trials (184 patients), the 2-year target lesion failure rate was 5.9% without any definite/probable scaffold thrombosis at early or late/very late phases.12In the current issue, Waksman et al13 compared acute thrombogenicity of the Magmaris, the Absorb scaffold, and the Orsiro metallic stent using arteriovenous (carotid jugular) shunt of a porcine model. The Orsiro stent is a permanent metallic stent with a thin strut thickness of 60 µm with a sirolimus elution from the similar polymeric coating of the Magmaris scaffold. On confocal microscopy and scanning electron microscopy, the Magmaris scaffold had significantly less thrombus deposition (5% versus 16.1%; P=0.02), less platelet adherence, and inflammatory cell adherence compared with Absorb. Furthermore, the Magmaris scaffold produced significantly less inflammatory cell adhesion even compared with the Orsiro stent. The Orsiro stent produced significantly less platelet and monocyte deposition, with a trend toward less neutrophil adherence and thrombus deposition compared with the Absorb scaffold.What Impacts on Acute Thrombogenicity of a Coronary Device?The ex vivo arteriovenous shunt model has been established both in human and in animal to examine the acute thrombogenicity of different type of coronary stents. In patients undergoing coronary angiography, the acute thrombus formation of CD-34 monoclonal antibody–coated Genous stent was compared with a bare-metal stent in an extracorporeal femoral arteriovenous shunt created during coronary angiography, demonstrating the increased endothelialization with Genous stent.14 In swine model, an ex vivo arteriovenous carotid to jugular shunt is used to evaluate the acute thrombogenicity and acute inflammatory cell adhesion after implantation of different type of drug-eluting stents and bare-metal stent. The everolimus-eluting fluoropolymer-coated Xience stent was shown to have less platelet aggregation compared with biodegradable polymer stents, such as BioMatrix and Synergy, and less inflammatory cell deposition against Biomatrix, Nobori, and Orsiro.15 The results of the ex vivo study seem consistent with the clinical findings.15In ex vivo model, the polymer coating, the dimension of strut, and strut positioning against vessel wall are considered as critical factors influencing stent thrombogenicity (Figure).16 Using a modified Chandler loop, Kolandaivelu et al demonstrated that drug/polymer coatings do not inherently increase thrombosis but reduce thrombosis.16 Acutely, in the absence of endothelial coverage of struts, the deposition of thrombin-generated fibrin occurred primarily in the recirculation zones created behind protruding struts.18,19 The thick protruding strut disrupts the laminar flow and induces flow disturbances and thereby endothelial shear stress microgradients. The shear microgradients can induce the formation of stabilized discoid platelet aggregates, the size of which is directly regulated by the magnitude and spatial distribution of the gradient.5 The magnitude of flow disturbance depends on the degree of protrusion of the strut into the lumen. The detachment of a strut from the vessel wall (malapposition) is also associated with higher flow disturbances around the edges, which could increase the risk of platelet activation and thrombi aggregation.16 In contrast, streamlining by changing the cross-sectional shape would reduce the size of recirculation zones.18 Compared with a square-shaped strut, a round-shaped strut has less disturbance in blood flow and could, therefore, be less thrombogenic.17Download figureDownload PowerPointFigure. The figure summarizes the factors influencing ex vivo thrombogenicity of the stent struts. A and B, Ex vivo thrombogenicity among drug-eluting stent (DES) and bare-metal stent (BMS) with polymer coating, respectively. Coated DES had less thrombogenicity than noncoated BMS. Panels A and B were reproduced with permission from Kolandaivelu et al.16 Stent geometry: In absence of strut tissue coverage, the areas of recirculation behind the struts are nidus of thrombus with the deposit of fibrin. The thin strut (E) or round strut (D) does not disturb the laminar flow, whereas the thick protruding strut disrupts the laminar flow and induces flow disturbances, and thereby endothelial shear stress (ESS) microgradients (C). The shear microgradients can induce the formation of stabilized discoid platelet aggregates, the size of which is directly regulated by the magnitude and spatial distribution of the gradient.5F–H, Shear stress simulation after implantation of Absorb (150 µm, square shape), Mirage (150 µm, round shape), and Arteriosorb (95 µm, square shape) using angiography and optical coherence tomography (reproduced with permission from Tenekecioglu et al17). In end-diastolic phase, the Absorb visually demonstrated larger low-shear stress area (<1 Pa) compared with the round shape or the thin thickness struts. Left, I–K, Pathlines generated by 1-mm fluorescent particles in the vicinity of a rectangular strut with 150 µm thickness, a circular arc strut with 100 µm thickness, and a rectangular strut with 50 µm thickness, respectively, under steady flow conditions demonstrating the formation of a range of recirculation zones by different geometries. Right, I–K, Images of proximal and distal fluorescent fibrin deposition near stent struts for undisturbed flow inlet boundary condition (I–K were adapted with permission from Jiménez et al18). Interaction of struts with vessel wall: L, Single strut 2-dimensional simulations with various displacements showing stent-wall recirculation zones that first grow in size, shift downstream of the stent, lose stent communication, and then fade away altogether. M, Increased visual clot burden observed with severe strut malapposition in an ex vivo setting. Figures reproduced with permission from Kolandaivelu et al.16 Authorization for this adaptation has been obtained both from the owner of the copyright in the original work and from the owner of copyright in the translation or adaptation.In the current report of Waksman et al,13 the observed low thrombogenicity of the Magmaris scaffold could be caused by various factors: coating, strut thickness, strut shape, and backbone material. Because the strut thickness of the Magmaris and the Absorb is almost identical (150 µm), the difference in platelet disposition between the 2 devices could be attributed to the difference in eluting drug (Sirolimus versus Everolimus), coating (poly-d,l-lactide coating versus poly-L-lactide coating), or the strut shape. The lower thrombogenicity of the Magmaris scaffold compared with the Absorb scaffold was consistently demonstrated in a recent pre-clinical study20; Histomorphometric analysis in juvenile hybrid farm swine demonstrated that acute thrombogenicity in coronary arteries was significantly lower in the Magmaris scaffold relative to the Absorb scaffold implanted at 3 days, with a higher re-endothelialization rate in the Magmaris scaffold. In addition, the Magmaris strut has a square shape but with rounded edges compared sharp edges of Absorb, which theoretically could alleviate shear stress disturbance.16The comparative results of the Magmaris scaffold to the Orsiro stent are intriguing; both devices demonstrated similar thrombogenicity, whereas the Magmaris scaffold had less inflammatory adhesion than the Orsiro stent. The 2 devices share the same type of drug/coating, and the Orsiro stent has a thinner strut than the Magmaris scaffold. From the rheological point of view, Orsiro could have less flow disturbance, however, the coating of both devices may be enough thromboresistant to overcome the shear stress difference. It remains speculative whether or not the presence of magnesium in backbone could reduce the thrombogenicity, as well as the inflammatory reaction.Potential Clinical Impact and Future OutlookThe current pre-clinical study suggested that the Magmaris BRS could express an antithrombotic effect and therefore potentially decreases the scaffold thrombosis risk in acute and early phase compared with the Absorb scaffold or even to a metallic stent. Although patient and technical factors (such as malapposition and underexpansion) could confound the results in clinical study, it is essential to corroborate the pre-clinical results with clinical trials. To date, no randomized trial has been performed to compare magnesium scaffold with polymeric scaffold or permanent metallic stent.Furthermore, it would be of paramount importance to investigate whether the risk of late and very late thrombosis (beyond 1 year) is mitigated with magnesium scaffold. The mechanism of late or very late scaffold thrombosis may be different from that of early thrombosis and be independent of acute thrombogenicity of the device; a recent analysis of all very late thrombosis cases of the Absorb scaffold analyzed by intravascular imaging reported in the literature indicated that in half of the thrombotic events might be related to the late structural discontinuities which occurs as a part of biodegradation process (≈3 years for Absorb).5 Thicker struts take a longer time to be covered by neointima, resulting in the direct contact of biodegrading polymer when the scaffold dismantles. The Magmaris BRS theoretically could minimize the risk of late events by its relatively short duration of bioresorption (≈1 year). Recently, the pooled analysis of BIOSOLVE-II and -III with 184 patients treated with a Magmaris scaffold demonstrated the absence of definite or probable scaffold thrombosis up to 24 months.12 The results should be confirmed with a larger population with long-term follow-up, ideally in a setting of randomized trial.The results of the current porcine study underline the fact that polymeric BRS and metallic BRS are not at all similar but have distinct features—no class effect. Further evaluation of the metallic Magmaris BRS in the context of clinical randomized trial is warranted. If such clinical trial results corroborate the current pre-clinical results, the Magmaris BRS would be a new hope for BRS to strike back after the current setback.DisclosuresDr Onuma is a member of advisory board of Abbott Vascular. Dr Serruys reports consultant fees from Abbott, AstraZeneca, Biotronik, Cardialysis, GLG Research, Medtronic, Sinomedical Sciences Technology, Société Europa Digital Publishing, Stentys France, Svelte Medical Systems, Volcano, St. Jude Medical, and Qualimed.FootnotesThe opinions expressed in this article are not necessarily those of the editors or of the American Heart Association.Correspondence to Yoshinobu Onuma, Erasmus University Medical Center, Thoraxcenter Gravendijkwal 230, Rotterdam, the Netherlands. E-mail [email protected]References1. Waksman R. Biodegradable stents: they do their job and disappear.J Invasive Cardiol. 2006; 18:70–74.MedlineGoogle Scholar2. Serruys PW, Garcia-Garcia HM, Onuma Y. From metallic cages to transient bioresorbable scaffolds: change in paradigm of coronary revascularization in the upcoming decade?Eur Heart J. 2012; 33:16–25b. doi: 10.1093/eurheartj/ehr384.CrossrefMedlineGoogle Scholar3. 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A translational approach targeting the role of neoatherosclerosis in late stent failure, European Heart Journal Supplements, 10.1093/eurheartj/suaa006, 22:Supplement_C, (C15-C25), Online publication date: 1-Apr-2020. Kassimis G and Picard F (2019) Resorbable Magnesium Scaffolds in Acute Myocardial Infarction Patients: "To Be or Not to Be"?, Cardiology, 10.1159/000499624, 142:2, (97-99), . August 2017Vol 10, Issue 8 Advertisement Article InformationMetrics © 2017 American Heart Association, Inc.https://doi.org/10.1161/CIRCINTERVENTIONS.117.005663PMID: 28801542 Originally publishedAugust 11, 2017 Keywordsmagnesiumbioresorbable scaffoldEditorialsthrombosisstentsmodels, animaldrug-eluting stentsPDF download Advertisement SubjectsPercutaneous Coronary InterventionStent
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