Iliac Anastomotic Stenting with a Sirolimus-Eluting Biodegradable Poly-L-Lactide Stent: A Preliminary Study after 6 Weeks

• Published in: Journal of endovascular therapy 2006-10, Vol.13 (5), p.630-639
• Main Authors: Bünger, Carsten Michael, Grabow, Niels, Kröger, Christina, Lorenzen, Björn, Hauenstein, Karlheinz, Goosmann, Martin, Schmitz, Klaus-Peter, Kreutzer, Hans Jürgen, Lootz, Daniel, Ince, Hüseyin, Nienaber, Christoph A., Klar, Ernst, Schareck, Wolfgang, Sternberg, Katrin
• Format: Article
• Language: English
• Subjects: Absorbable Implants; Anastomosis, Surgical; Animals; Biodegradable materials; Blood Vessel Prosthesis Implantation; Cell cycle; Chromatography; Coated Materials, Biocompatible - pharmacology; Design; Disease Models, Animal; Extremities - blood supply; Feasibility Studies; Female; Graft Occlusion, Vascular - etiology; Graft Occlusion, Vascular - physiopathology; Iliac Artery - drug effects; Iliac Artery - physiopathology; Iliac Artery - surgery; Immunosuppressive Agents - pharmacology; Injury Severity Score; Materials Testing; Mechanical properties; Polyesters - pharmacology; Prosthesis Design - instrumentation; Random Allocation; Research Design; Silicon carbide; Sirolimus - pharmacology; Stents; Studies; Swine; Tunica Intima - injuries; Tunica Intima - physiopathology; Vascular Patency - drug effects; Veins & arteries
• ISSN: 1526-6028; 1545-1550
• DOI: 10.1583/06-1899R.1

Purpose: To assess technical feasibility and biocompatibility of a new biodegradable sirolimus-eluting poly-L-lactide (PLLA) vascular anastomotic stent. Methods: A polytetrafluoroethylene bifurcated graft was implanted in 9 pigs through a midline abdominal incision. After transverse graft limb incision, 6 unloaded PLLAs, 6 sirolimus-loaded PLLAs, and 6 unloaded stainless steel (316L) stents were randomly implanted at both iliac anastomotic sites. Stents were deployed with a 6-mm balloon under direct vision without the use of angiography. Prior to sacrifice after 6 weeks, contrast-enhanced computed tomography (CT) was performed to determine patency of the target vessels. Stented segments were surgically explanted and processed for histology to measure the mean luminal diameter and intimal thickness and to assign vascular injury and inflammation scores. Results: No animals were lost during the study period. All stented graft limbs were patent on CT and histology. At the anastomotic sites and iliac arteries, the mean luminal diameter of SIR-PLLA stents (4.11±0.15 and 4.08±0.13 mm, respectively) were comparable to metal stents (4.23±0.35 and 4.21±0.26 mm, respectively), but significantly higher compared to unloaded PLLA stents [3.32±0.56 mm (p