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Absorb bvs

Manufactured by Abbott
Sourced in United States

The Absorb BVS is a fully bioresorbable vascular scaffold (BVS) designed for the treatment of coronary artery disease. It provides temporary scaffolding to the artery, allowing for natural vessel healing and restoration of blood flow.

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11 protocols using absorb bvs

1

Absorb BVS vs Xience EES in PCI

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The AIDA compared Absorb BVS (Abbott Vascular, Santa Clara, CA, USA) with Xience EES (Abbott Vascular, Santa Clara, CA, USA) in routine PCI. The study design [16 (link)], the preliminary safety report [6 (link)], and the 2-year results [15 ] have been published previously.
Briefly, between August 2013 and December 2015, 1845 consecutive patients with coronary artery disease undergoing PCI with one or more target lesions suitable for drug-eluting stent implantation were included in AIDA. Key exclusion criteria were target lesions longer than 70 mm, a visually estimated reference vessel diameter of < 2.5 mm of > 4.0 mm, treatment of a true bifurcation lesion with a priori planned two device strategy, and treatment of in-stent restenosis. Patients were randomized after successful pre-dilatation of the first lesion. Device sizing was based on visual assessment by the operator. Online QCA, or periprocedural testing of cardiac biomarkers, were not mandatory. Device implantation strategy was planned according to the instructions for use of the implanted device.
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2

Comparison of Absorb BVS and Xience V

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The Absorb BVS (Abbott Vascular, Santa Clara, USA) is a fully bioresorbable vascular scaffold which consists of a fully biodegradable poly-L-lactide (PLLA) platform covered by an amorphous matrix of poly-D,L-lactide (PDLLA) and everolimus. It is gradually resorbed in the process of hydrolysis to non-inflammatory products, such as CO2 or H2O [3 ]. The average strut thickness is 157 µm. Eighty percent of drug release occurs within 30 days.
The Xience V (Abbott Vascular, CA, USA) is a cobalt-chromium stent coated with a non-erodible fluoropolymer loaded with 100 μg/cm2 of everolimus. The thickness of the metallic struts and coating combined is approximately 90 µm (81 µm for the stent and 7.8 µm for the polymer ≈ 90) [8 ]. The antiproliferative drug concentration and release profile are similar in both stents.
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3

Absorb BVS Performance in Middle East Patients

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This investigator-initiated prospective registry study evaluated the performance, safety and clinical outcome of Absorb BVS (Abbott Vascular) in treating an initial series of coronary lesions in an all-comers Middle East patient population. Patients were enrolled between 19 March 2012 and 10 April 2014, and were derived from an all-comers patient population referred to the PCI centre, Cardiology Department, Al Qassimi Hospital, Sharjah, UAE, and who satisfied the eligibility criteria for implantation of Absorb BVS. Patients were eligible for the register if they were ≥18 years old with evidence of myocardial ischaemia, including stable angina, acute coronary syndrome, silent ischaemia or evidence of myocardial ischaemia on non-invasive testing. Patients with severe haemodynamic compromise including cardiogenic shock and/or severe congestive heart failure, limited life expectancy, and patients who could not adhere to prolonged dual antiplatelet therapy (DAPT) were excluded. All patients admitted for PCI were considered for participation in the registry, but the decision to implant Absorb BVS was left to the discretion of the operating physician performing standard PCI, and trained for Absorb BVS implantation.
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4

Modeling Bioresorbable Scaffold Geometry

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The geometry of the deployed scaffold was constructed based on the structure of an actual 3.0 × 18 mm Absorb BVS (Abbott Vascular, SC, Calif.) utilizing the validated software Rhino 5.0 (www.rhino3D.com) for solid modeling. We modeled 19 horizontal rings interconnected by 3 vertical bridges. We performed simulations in two idealized vessel geometries, a straight vessel and a curved vessel with a 90° angle. We examined 2 stages in each vessel model Stage I: post-implantation, where the strut thickness is 0.015 cm (150 μm); the distance between each strut 0.1 cm, the degree of embedding in the vessel wall 50% simulating half-embedded struts, (the distance between the endoluminal and abluminal strut surface: 0.0075 cm) and the radius of the vessel lumen 0.15 cm and stage II: follow-up, where the strut thickness is reduced to 0.010 cm (67%) reflecting a 33% strut bioresorption and the radius of the lumen reduced to 0.14975 cm simulating some degree of bioresorption and neointimal hyperplasia (NIH), respectively.
Since we are interested in the changes in WSS around the struts we defined three different strut surfaces: 1. Lateral inflow, the surface facing the inflow area, 2. Lateral outflow, the surface facing the outflow area and 3. Endoluminal strut surface, the top surface of the strut (Electronic Supplement).
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5

Comparison of Magmaris and ABSORB BVS

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Magmaris, previously known as DREAMS 2G, is the bioresorbable magnesium scaffold CE marked in Europe since June 2016. It is a bioresorbable metal scaffold that is coated with a BIOlute poly-L-lactide (PLLA) biodegradable polymer that elutes sirolimus. PLLA is biocompatible and capable of self-catalyzing hydrolytic degradation to lactic acid. The drug release time is calibrated for approximately 90 days, whereas the PLLA resorption time is 2 years. The Magmaris device’s backbone is completely radiolucent. To navigate the scaffold implantation under an X-ray, two permanent tantalum radiopaque markers are attached to the distal and proximal ends. The average complete scaffold resorption time is approximately one year. Magmaris has an average strut thickness of 150 μm and is available in diameters of 3.0 and 3.5 mm and lengths of 15, 20, and 25 mm.
The ABSORB BVS (Abbott-Vascular, Chicago, IL, USA) backbone was constructed of poly-L-lactic acid covered with an everolimus-eluting polymer, both of which resorb in approximately 3 years. The average strut thickness is 150 μm. The device is available in a wide range of diameters and lengths (diameters from 2.5 to 3.5 mm and lengths from 8 to 28 mm), but in this study, we only included scaffolds within the size corresponding to Magmaris (diameters 3.0 mm or 3.5 mm and lengths 12, 18, or 24 mm).
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6

Bioresorbable Scaffolds Comparison in Pigs

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Eight Yucatan mini pigs with healthy coronaries underwent PCI in the three epicardial coronary arteries through the femoral access according to the standard procedures [13 (link)]. Six coronary arteries were implanted with a single Absorb everolimus-eluting Bioresorbable Vascular Scaffolds (Absorb BVS, Abbott Vascular), six coronaries with a Mirage sirolimus-eluting Bioresorbable Microfiber Scaffold (Mirage BRMS, Manli Cardiology) with 150 micron (µm) strut thickness (Mirage-150) and five coronary arteries with a Mirage BRMS with 125 µm strut thickness (Mirage-125). The protocol approval for the animal study was received from the Institutional Animal Care and Use Committee. The study was conducted in accordance to the American Heart Association guidelines for preclinical research and the Guide for the Care and Use of Laboratory Animals [14 ].
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7

Absorb BVS Implantation Protocol

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The Absorb BVS, an everolimus-eluting bioresorbable stent, by Abbott Vascular (Santa Clara CA, USA) was used for revascularisation of de novo disease in the setting of stable angina or acute coronary syndrome.
Patients were pre-treated with aspirin and a P2Y12 inhibitor. Full anti-coagulation was obtained during intervention with use of unfractionated heparin or bivalirudin. The PCI strategy and use of GPIIb/IIIa inhibitors was left to the discretion of the interventionalist. Lesion pre-dilation was considered mandatory and aggressive vessel preparation prior to scaffold deployment was strongly advocated. Deployment of the scaffold was undertaken using the manufacturer's recommendation of 2 atm pressure increase every five seconds. Scaffolds were to cover 2mm of nondiseased vessel proximal and distal to the target lesion. Intracoronary imaging (OCT or IVUS) was non-mandated and performed at the operator's discretion. Dual antiplatelet therapy with aspirin combined with clopidogrel, prasugrel or ticagrelor was prescribed in all patients on discharge with a plan to continue for a minimum duration of 12 months.
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8

Expansion Behavior of Everolimus-Eluting Scaffolds

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We tested the expansion behaviour of the everolimus-eluting bioresorbable vascular scaffold (3.0×18 mm Absorb BVS; Abbott Vascular, Santa Clara, CA, USA) and an everolimus-eluting metallic DES (3.0×18 mm XIENCE Prime; Abbott Vascular) in an identical coronary artery lesion model. The lesion models were made from silicone (MED-4735 with 35 Shore hardness; NuSil Technology LLC, Carpinteria, CA, USA) with a 0.45 mm wall thickness, a reference diameter of 2.75 mm and a minimal lumen diameter of 1.6 mm, representative of a 40% diameter stenosis lesion (material properties: isotropic-elastic; density 1,110 kg/m 3 ; Young's modulus 1.2 MPa; Poisson's ratio 0.48). The devices were advanced in the model to cross the lesion and then deployed at their nominal pressure (NP): 7 atm for the BVS (with slow inflation at 1 atm/2 s) and 10 atm for the XIENCE metallic DES. After microscopy and optical coherence tomographic evaluation, the devices were further dilated to 18 atm using their delivery balloon. Three samples in each arm were tested for the two inflation pressures and all experiments were performed in a 37°C water bath. Twelve experiments were performed in total.
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9

Bioresorbable ABSORB™ BVS Scaffold

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The ABSORB™ BVS (Abbott Vascular, USA) is a balloon-expandable, fully bioresorbable scaffold that consists of a poly (L-lactide) backbone with a poly (D,L-lactide) coating in a 1:1 ratio with everolimus.
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10

Bioresorbable Vascular Scaffold: Design and Properties

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The second-generation BVS (Absorb BVS; Abbott Vascular, Santa Clara, CA, USA) is a balloon-expandable scaffold consisting of a polymer backbone of poly-L-lactide (PLLA) coated with a thin layer of a 1:1 mixture of an amorphous matrix of poly-D, L-lactide (PDLLA) polymer and 100 μg/cm 2 of the antiproliferative drug everolimus. Two platinum markers located at each BVS edge allow enhanced visualisation of the radiolucent BVS during angiography or other imaging modalities. The PDLLA controls the release of everolimus and 80% of the drug is eluted within the first 30 days. Both PLLA and PDLLA are fully bioresorbable. The polymers are degraded via hydrolysis of the ester bonds, and the resulting lactate and its oligomers are transformed to pyruvate and metabolised in the Krebs cycle. Small particles, less than 2 μm in diameter, have also been shown to be phagocytised and degraded by macrophages. According to preclinical studies 14 , complete bioresorption of the polymer backbone occurs from two to three years after implantation 15 .
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