Serial observation of drug-eluting absorbable metal scaffold: multi-imaging modality assessment.

MedStar author(s):
Citation: Circulation: Cardiovascular Interventions. 6(6):644-53, 2013 Dec.PMID: 24254708Institution: MedStar Heart & Vascular InstituteForm of publication: Journal ArticleMedline article type(s): Clinical Trial | Journal Article | Multicenter Study | Research Support, Non-U.S. Gov'tSubject headings: *Absorbable Implants | *Angioplasty/is [Instrumentation] | *Coronary Artery Disease/th [Therapy] | *Magnesium | *Sirolimus/aa [Analogs & Derivatives] | *Tissue Scaffolds | Angioplasty/mt [Methods] | Coronary Angiography | Coronary Artery Disease/ra [Radiography] | Coronary Artery Disease/us [Ultrasonography] | Follow-Up Studies | Humans | Incidence | Neointima/ep [Epidemiology] | Neointima/ra [Radiography] | Neointima/us [Ultrasonography] | Tomography, Optical Coherence | Treatment Outcome | Ultrasonography, InterventionalYear: 2013Local holdings: Available online from MWHC library: 2008 - presentISSN:
  • 1941-7640
Name of journal: Circulation. Cardiovascular interventionsAbstract: 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.CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT01168830.CONCLUSIONS: This serial analysis of drug-eluting absorbable metal scaffold confirmed the safety and efficacy of this new device, with vasomotion restoration and continued degradation over time demonstrated by multi-invasive imaging modalities.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 141111s 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 141111s 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 un141111d from 6 to 12 months.All authors: Bose D, Bruining N, Degen H, Di Vito L, Erbel R, Erne P, Haude M, Kitabata H, Koolen J, Prati F, Verheye S, Vermeersch P, Waksman RFiscal year: FY2014Digital Object Identifier: Date added to catalog: 2014-11-11
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Item type Current library Collection Call number Status Date due Barcode
Journal Article MedStar Authors Catalog Article 24254708 Available 24254708

Available online from MWHC library: 2008 - present

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.

CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT01168830.

CONCLUSIONS: This serial analysis of drug-eluting absorbable metal scaffold confirmed the safety and efficacy of this new device, with vasomotion restoration and continued degradation over time demonstrated by multi-invasive imaging modalities.

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 141111s 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 141111s 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 un141111d from 6 to 12 months.

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