Feasibility, safety, and preliminary efficacy of a novel ePTFE‐covered self‐expanding stent in saphenous vein graft lesions: The Symbiot II trial

Compared with percutaneous interventions in native coronary arteries, revascularization of saphenous vein graft (SVG) lesions is associated with increased rates of immediate and long‐term major adverse cardiac events (MACE). The Symbiot II trial was a multicenter prospective study designed to evaluate the feasibility and safety of a novel self‐expanding polytetrafluoroethylene (ePTFE)‐covered stent in the treatment of de novo and restenotic SVG lesions. The primary endpoint was MACE through 30 days postprocedure. Successful Symbiot stent deployment was achieved in 75 of 77 patients (97.4%) with SVG lesions ≤ 35 mm in length (visual assessment). The procedural success rate (defined as < 30% residual stenosis at the target site and no clinical complications) was 83%, and all study device procedures provided grade 3 TIMI flow postprocedure. Within the first 30 days postprocedure, four patients (5.2%) experienced MACE (defined as death, Q‐wave or non‐Q‐wave myocardial infarction, and clinically driven target vessel revascularization), of whom three patients (3.9%) experienced periprocedural non‐Q‐wave myocardial infarction. No subacute stent thrombosis was observed over the 6‐month follow‐up period. No relevant luminal loss at the target site (mean, 0.3 ± 0.9 mm) was observed in the 58 patients (77.3% of enrolled patients) who underwent quantitative coronary angiography at 6 months. The incidences of binary in‐stent restenosis, in‐segment restenosis, and target vessel failure (defined as acute and late‐term MACE through 6 months postprocedure) were low (7.0%, 8.6%, and 14.3%, respectively). The Symbiot self‐expanding ePTFE membrane‐covered stent was associated with a high procedural success rate (97.4%), low incidences of MACE at 30 days (5.2%) and 6 months (14.3%), suggesting that it is safe and effective in the treatment of SVG disease. Catheter Cardiovasc Interv 2005;64:361–368. © 2005 Wiley‐Liss, Inc.