Serial observation of drug-eluting absorbable metal scaffold: multi-imaging modality assessment.
Serial observation of drug-eluting absorbable metal scaffold: multi-imaging modality assessment.
- 2013
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.
English
1941-7640
*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, Interventional
MedStar Heart & Vascular Institute
Clinical Trial
Journal Article
Multicenter Study
Research Support, Non-U.S. Gov't
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.
English
1941-7640
*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, Interventional
MedStar Heart & Vascular Institute
Clinical Trial
Journal Article
Multicenter Study
Research Support, Non-U.S. Gov't