Serial In Vivo Intravascular Ultrasound-Based Echogenicity Changes of Everolimus-Eluting Bioresorbable Vascular Scaffold During the First 12 Months After Implantation

Brugaletta, Salvatore; Gomez‐Lara, Josep; Serruys, Patrick W.; Farooq, Vasim; Geuns, Robert Jan van; Thuesen, Leif; Dudek, Dariusz; Koolen, Jacques; Chevalier, Bernard; McClean, Dougal; Windecker, Stephan; Smits, Pieter C.; Bruyne, Bernard De; Whitbourn, Robert; Meredith, Ian T.; Domburg, Ron T. van; Sihan, Kenji; Winter, Sebastiaan de; Veldhof, Susan; Miquel-Hébert, Karine; Rapoza, Richard; García‐García, Héctor M.; Ormiston, John A.; Bruining, Nico

doi:10.1016/j.jcin.2011.08.014

Cited by 22 publications

(14 citation statements)

References 35 publications

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“…This effect can be measured and quantified for whichever 2 methods have been applied (eg, differential quantitative echogenicity and VH-IVUS). 13,[19][20][21] The results of the DREAMS serial VH-IVUS analysis have been previously reported. 7 In brief, serial VH-IVUS analysis showed a significant decrease in dense calcium at 6 and 12 months compared with postprocedure (15.4% reduction between 6 months and after procedure, P=0.0015; 12.9% reduction between 12 months and after procedure, P=0.0029), with no significant changes in necrotic core over time.…”

Section: Metal Absorption By Ivus and Octmentioning

confidence: 86%

“…Interestingly, the reduction rate in hyperechogenicity, which reflects a degradation rate of DREAMS, was similar to that observed with the second-generation BVS 1.1. 21,22 These results suggest that quantitative differential echogenicity is a useful method for monitoring the degradation process of absorbable metallic scaffolds. Furthermore, on OCT, 85.7% of the scaffold struts at 6 months and only 61.1% at 12 months were discernible, indicating continued resorption of DREAMS over time.…”

Section: Downloaded Frommentioning

confidence: 87%

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Serial Observation of Drug-Eluting Absorbable Metal Scaffold

Waksman

Prati

Bruining

et al. 2013

Circ: Cardiovascular Interventions

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1,2 stent thrombosis, especially at the late phase, remains a major concern, probably related to delayed healing, chronic inflammation, and impaired endothelialization.3 Furthermore, metallic stents are associated with artifacts in noninvasive imaging of MRI or multislice computed tomography, impairment of vessel geometry, and often jailing of side branches. Because of their permanent nature, metallic stents can also induce neoatherosclerosis during long-term follow-up. 4 Polymeric bioabsorbable temporary scaffolds have been developed to resolve these limitations. Second-generation bioabsorbable everolimus-eluting scaffold systems (BVS 1.1, ABSORB; Abbott Vascular, Santa Clara, CA) have shown a late lumen loss at 12 months similar to that seen with permanent everolimus-eluting stents (EES), along with a major adverse cardiac event rate of 7.1%. 5 In addition, unlike permanent metallic stents, interesting observations of the bioresorbable vascular scaffold technology are vessel lumen enlargement during follow-up and the ability of the vessel to Background-The drug-eluting absorbable metal scaffold has demonstrated feasibility, safety, and promising clinical and angiographic outcomes at 12 months in human coronary arteries. This study aimed to evaluate the degradation rate and long-term vascular responses to drug-eluting absorbable metal scaffold. Methods and Results-BIOSOLVE-I was a multicenter, single-arm, first-in-man trial assessing the safety and performance of drug-eluting absorbable metal scaffold in 46 patients with coronary artery disease. Patients who underwent serial invasive imaging, such as quantitative coronary angiography, intravascular ultrasound, and optical coherence tomography, at 6 and 12 months were included in this study. From postimplantation to follow-up, arterial curvature and angulation were significantly increased by the degradation process. The greatest increase was seen from postimplantation to 6 months. The systolic-diastolic changes of the curvature and angulation gradually improved throughout the follow-up period. At the site of implantation, vasoconstriction (−10% mean reduction) was observed during the acetylcholine test at 6 months. The average percent hyperechogenicity of the scaffolded segments showed a continuous decrease over time, with the most pronounced changes within the first 6 months (from 22.1±7.0% to 15.8±3.7%; P<0.001). Struts discernible on optical coherence tomography at 6 and 12 months showed full neointimal coverage, with stabilization of the mean scaffold area from 6 to 12 months. Furthermore, the mean neointimal area (1.55±0.51 versus 1.58±0.34 mm 2 ; P=0.794) remained unchanged from 6 to 12 months. Conclusions-This

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Section: Metal Absorption By Ivus and Octmentioning

confidence: 86%

Section: Downloaded Frommentioning

confidence: 87%

Serial Observation of Drug-Eluting Absorbable Metal Scaffold

Waksman

Prati

Bruining

et al. 2013

Circ: Cardiovascular Interventions

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“…Unlike the first-generation ABSORB BVS 1.0, the backscattering of the polymeric Metallic stent BVS Device Profile struts did not decrease over time, which suggests a more delayed loss of mechanical integrity compared with the BVS 1.0 [29,30,48]. At the same time, the echogenicity ana lysis showed a smaller reduction (15 and 20% at 6 and 12 months, respectively) in the hyperechogenicity of the scaffolded segment compared with the BVS 1.0 [49]. Nevertheless, at 12 months the scaffolded segments exhibited clear signs of pharmacologically induced vasomotion (either with methergin or with acetyl choline), suggesting that the mechanical integrity and radial force of the scaffold were substantially subsided [29].…”

Section: Lessons From the Absorb Cohort B Studymentioning

confidence: 80%

Everolimus-eluting ABSORB bioresorbable vascular scaffold: present and future perspectives

Brugaletta

García‐García

Onuma

et al. 2012

Expert Review of Medical Devices

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Everolimus-eluting ABSORB bioresorbable vascular scaffolds represent a novel approach that provides transient vessel support with drug-delivery capability without the long-term limitations of the metallic drug-eluting stents (DESs). The technology has the potential to overcome many of the safety concerns associated with metallic DESs and possibly even convey further clinical benefit. In particular the scaffold is designed for providing a short-term lumen support (up to 6-12 months) and for thereafter being completely bioresorbed, eliminating the permanent caging typical of the metallic DES. The first clinical studies testing this device in a small number of patients have shown very promising results with good clinical outcome up to 5 years' follow-up, highlighting important morphological and functional modifications at the scaffolded segment level, such as late lumen enlargement and recuperation of a normal vasoreactivity. A randomized trial, comparing ABSORB with the Xience Prime stent, will evaluate the efficacy and safety of this device in a wide population.

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“…Favorable features of BVS involve restoration of native vessel vasomotion, prevention of expansive remodeling, improvement of plaque stability, late lumen enlargement and potential avoidance of long-term complications, such as stent thrombosis, restenosis and neoatherosclerosis [1][2][3][4]. These beneficial effects were confirmed in preliminary studies in patients with stable coronary artery disease [4][5][6][7][8][9][10][11][12].…”

Section: Introductionmentioning

confidence: 98%