Efficacy and Safety of a Polytetrafluoroethylene Membrane Wrapped a Single Layer of Sirolimus-Eluting Stent in a Porcine Coronary Perforation Model

Background: Covered stents are effective in treating coronary artery perforation (CAP), however, the high rate of immediate device deployment failure and in-stent restenosis have limited application currently covered stents. Methods: We designed a stent system consisting single layer drug-eluting polytetrafluoroethylene (PTFE) membrane wrapped at outer stent. The sealing effect our novel was observed by using an Ellis type III CAP model. device’s success defined as its ability to seal perforation, assessed visual estimation final thrombolysis myocardial infarction (TIMI) 3 flow. antiproliferative evaluated 12 swine, which were randomly assigned treatment (sirolimus-eluting stents) control (bare metal groups. Coronary angiography optical coherence tomography (OCT) performed index procedure, 1- 6-month after implantation. All swine sacrificed for histopathological analyses 6-month. Results: 100%. alive follow-up. At 1-month, group had larger minimal luminal diameter (MLD) (1.89 ± 0.29 mm vs. 0.63 0.65 mm, p = 0.004) lower late loss (LLL) (0.47 0.15 1.80 0.34 < 0.001) compared with group. 6-month, numerically higher MLD (0.94 0.75 0.26 0.46 mm; 0.230) LLL (1.43 0.85 2.17 0.28 0.215) Histological revealed mean plaque area (2.99 0.81 mm2 4.29 0.77 mm2, 0.035) than No thrombosis either Conclusions: In porcine model PTFE sirolimus-eluting showed perforation. demonstrated relatively sustained up 6 months post-implantation.