Long-term follow-up after percutaneous coronary intervention with polytetrafluoroethylene-covered Symbiot<sup>TM</sup> stents compared to bare metal stents, with and without FilterWire<sup>TM</sup> embolic protection, in diseased saphenous vein grafts

J. Bennett; J. Dens; F. Stammen; P. Coussement; L. Janssens; M. Claeys; M. Vrolix; P. Sinnaeve; C. Dubois; W. Desmet

Document Details :

Title: Long-term follow-up after percutaneous coronary intervention with polytetrafluoroethylene-covered Symbiot^TM stents compared to bare metal stents, with and without FilterWire^TM embolic protection, in diseased saphenous vein grafts
Author(s): J. Bennett , J. Dens , F. Stammen , P. Coussement , L. Janssens , M. Claeys , M. Vrolix , P. Sinnaeve , C. Dubois , W. Desmet
Journal: Acta Cardiologica
Volume: 68 Issue: 1 Date: 2013
Pages: 1-9
DOI: 10.2143/AC.68.1.2959625

Abstract :
Objectives: The long-term clinical outcome of covered stents in the percutaneous treatment of diseased saphenous vein graft (SVG) has been disappointing. The single self-expanding polytetrafl uoroethylene (PTFE)-covered Symbiot stent with a unique profile may present advantages that translate into superior long-term clinical outcomes. This study evaluated the safety, effectiveness and clinical outcome of the Symbiot^TM covered stent system (Boston Scientific, Natick, Mass.) and FilterWire^TM EX (Boston Scientific, Natick, Mass.) versus bare metal stents (BMS) in SVG intervention.
Methods and results: Between January 2003 and August 2005, 90 patients with degenerative SVG lesions were prospectively randomized at 6 study sites to Symbiot implantation (n = 30), BMS with FilterWire as embolic protection device (EPD, n = 30), or BMS without EPD (control group, n = 30). The primary end point was reduction in peri-procedural cardiac enzyme rise. The major secondary end points were in-hospital, 6-month and long-term target vessel failure rates, defined as the cumulative of death, myocardial infarction and clinically driven target lesion revascularization. There was no significant reduction in median [IQR] post-procedural troponin-I rise in the Symbiot group compared to the FilterWire or the control group (0.08 [0-1.40] μg/l; 0.06 [0-0.28] μg/l; and 0.04 [0-0.31] μg/l, P = 0.58). At 7.4 ± 1.3 (mean ± SD) years, there were numerically less deaths in the Symbiot group, although this did not reach statistical significance (P = 0.20). There was no significant difference in TVF-free survival between the treatment groups (P = 0.98).
Conclusion: This study failed to show a procedural or long-term clinical advantage for the Symbiot PTFE-covered stent in the treatment of degenerated SVG.