Use of a self-expanding super-elastic all-metal endoprosthesis; to treat degenerated SVG lesions: the SESAME first in man trial.

ABSTRACT

UNLABELLED We prospectively evaluated a novel nano-synthesized, membrane-covered self-expanding super-elastic all-metal endoprosthesis stent (SESAME Stent) in patients undergoing percutaneous intervention (PCI) of degenerated saphenous vein graft (SVG) lesions. METHODS: SESAME investigators prospectively enrolled 20 patients/21 lesions at 2 outside United States (OUS) centers, between February 2005 and August 2005. Patients underwent elective intervention of symptomatic SVG lesions with ≥ 50% stenosis. PCI was performed without embolic protection devices. The primary end point was technical and procedural success. Secondary end points included major adverse cardiac events (MACE) at 30 days and 9 months. RESULTS: Twenty patients (twenty-one SVG lesions) received SESAME stents. The acute success was 100%. No procedural or in hospital complications occurred. One patient underwent a planned staged PCI at 28 days in a separate SVG. Follow-up was present in 20 patients at 30 days, with clinical (n = 19) and angiographic evaluation (18 patients/19 lesions) at 9 months. No MACE events occurred at 30 days. At 9 months, 3 patients underwent repeat PCI. One TLR (restenosis at the overlap of two stents) and two nonindex lesion TVR for a MACE rate of 14% at 9 months. CONCLUSIONS: This study demonstrated the ABPS SESAME Stent has excellent acute success, low 30 day MACE rates and 9 month patency of the SESAME is similar to balloon expandable stents without embolic protection.