Affiliation: | 1.Department of Cardiology,Albert Schweitzer Hospital,Dordrecht,The Netherlands;2.Department of Cardiology,Erasmus Medical Centre,Rotterdam,The Netherlands;3.STENTYS,STENTYS SA,Paris,France;4.Department of Cardiology,Onze Lieve Vrouwe Gasthuis,Amsterdam,The Netherlands;5.Department of Cardiology,ZNA Middelheim,Antwerpen,Belgium;6.Department of Cardiology,Satakunta Hospital,Pori,Finland |
Abstract: | AimsTo describe the safety and performance of STENTYS self-expandable bare metal stents (BMS) versus paclitaxel-eluting stents (PES) in saphenous vein grafts (SVGs).Methods and ResultsA randomised controlled trial was performed in four hospitals in three European countries between December 2011 and December 2013. Patients with de novo lesions (>50% stenosis) in an SVG with a diameter between 2.5–6?mm were included. Primary endpoint was late lumen loss at 6 months. Secondary endpoints included procedural success and the occurrence of major adverse cardiac events (MACE) at 12 months. A total of 57 patients were randomised to STENTYS self-apposing BMS (n = 27) or PES (n = 30). Procedural success was obtained in 89.5%. No significant differences in late lumen loss were found between BMS and PES at 6 months (0.53?mm vs 0.47; p = 0.86). MACE rates at 12 months were comparable in both groups (BMS 22.2% vs. PES 26.7%; p = 0.70).ConclusionsTreatment of SVGs with STENTYS self-expandable stents is safe and effective. No significant differences were found in late lumen loss and MACE between BMS and PES. |