novolimus and Coronary-Stenosis

The DESolve® scaffold (Elixir Medical Corporation, Sunnyvale, California, USA) is manufactured from a poly-l-lactide based polymer and elutes an anti-proliferative, anti-inflammatory drug, Novolimus from a poly-l-lactide based topcoat mixture. The strut thickness is 150μm and the scaffold has platinum-iridium radiopaque markers at both ends. Radial support is available during the early time period to prevent recoil. The scaffold biodegrades within 1year (>90% reduction in molecular weight) and then completely bioresorbs within 2years. The DESolve® scaffold permits a wide range of expansion with a consequently reduced risk for strut fracture. Lumen and scaffold enlargement is observed within 3-6months in both preclinical and clinical studies potentially allowing for the scaffolded region to respond to vasoactive stimuli. The device has a unique property of self-correction observed in bench top studies, which in clinical practice has the potential to eliminate minor malapposition following deployment.

Topics: Absorbable Implants; Coronary Angiography; Coronary Stenosis; Drug-Eluting Stents; Female; Follow-Up Studies; Forecasting; Humans; Macrolides; Male; Percutaneous Coronary Intervention; Risk Assessment; Tissue Scaffolds; Treatment Outcome; Vascular Patency

Topics: Absorbable Implants; Biocompatible Materials; Coronary Artery Disease; Coronary Stenosis; Drug-Eluting Stents; Humans; Immunosuppressive Agents; Macrolides; Percutaneous Coronary Intervention; Treatment Outcome

Topics: Absorbable Implants; Aged; Coronary Angiography; Coronary Stenosis; Coronary Vessels; Drug-Eluting Stents; Follow-Up Studies; Graft Occlusion, Vascular; Humans; Macrolides; Male; Percutaneous Coronary Intervention; Prosthesis Design; Prosthesis Failure; Reoperation; Tissue Scaffolds; Tomography, Optical Coherence

The objective was to investigate the acute mechanical effects of post-dilatation on bioresorbable scaffolds (BRS) as determined by optical coherence tomography (OCT).. Post-dilatation with high-pressure balloons is regarded as a key component of BRS implantation for treatment of coronary artery stenoses. However, the impact of post-dilatation on BRS in vivo has not been thoroughly investigated.. OCT was performed after the implantation procedure of 51 everolimus-eluting or novolimus-eluting polylactic acid-based BRS with (n = 27) or without non-compliant balloon post-dilatation (n = 24). The number of malapposed struts, strut fractures, edge dissections, residual in-scaffold area stenosis, and incomplete scaffold apposition area was analyzed over the complete length of each BRS with a spacing of 1 mm.. OCT revealed a significantly lower incomplete scaffold apposition area if post-dilatation was performed (0.16 ± 0.49 mm. Post-dilatation of BRS with non-compliant balloons significantly reduces the number of malapposed struts and incomplete scaffold apposition area without inducing higher rates of edge dissection or strut fracture.

Topics: Absorbable Implants; Coronary Angiography; Coronary Stenosis; Coronary Vessels; Drug-Eluting Stents; Everolimus; Female; Follow-Up Studies; Humans; Immunosuppressive Agents; Macrolides; Male; Middle Aged; Percutaneous Coronary Intervention; Pressure; Prosthesis Design; Prosthesis Failure; Retrospective Studies; Risk Factors; Stress, Mechanical; Time Factors; Tomography, Optical Coherence; Treatment Outcome

Overlapping implantation of bioresorbable vascular scaffolds is frequently necessary, but its influence on vessel and scaffold structure has not been thoroughly analyzed previously. The aim of this study was to analyze the acute effects of overlapping implantation on BRS as determined by optical coherence tomography (OCT). A total of 38 patients with de novo coronary artery stenoses who underwent OCT in the context of implantation of novolimus-eluting BRS (DESolve, Elixir Medical Corporation, Sunnyvale, California, USA) were investigated. In 15 patients, overlapping implantation of two BRS was performed, while 23 patients with implantation of one single BRS served as the control group. OCT data were retrospectively analyzed regarding acute scaffold implantation results. There were no significant differences between the overlap and control group in terms of residual in-scaffold area stenosis, scaffold area, mean or minimal lumen area, eccentricity index, incomplete scaffold apposition area or malapposition. While strut fracture was slightly more frequent in BRS with overlap its incidence was low overall. In patients with overlapping BRS, overlap segments did not display smaller lumen areas than segments without overlap (mean lumen area overlap: 8.16 ± 2.97 mm

Topics: Absorbable Implants; Aged; Coronary Angiography; Coronary Stenosis; Everolimus; Female; Germany; Humans; Macrolides; Male; Middle Aged; Percutaneous Coronary Intervention; Retrospective Studies; Tissue Scaffolds; Tomography, Optical Coherence; Treatment Outcome

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiac Catheters; Cardiovascular Agents; Coated Materials, Biocompatible; Coronary Angiography; Coronary Stenosis; Coronary Vessels; Drug-Eluting Stents; Humans; Macrolides; Male; Prosthesis Design; Prosthesis Failure; Retreatment; Time Factors; Tomography, Optical Coherence; Treatment Outcome