On the opening day of the CX symposium in a session entitled, ‘Superficial femoral artery stenting’, Chaired by Dr Jan Brunkwall, Cologne, Germany, Dr Johannes Lammer, Vienna, Austria, will report the level of evidence for angioplasty vs. angioplasty and stenting in the superficial femoral artery.
Lammer will assess the level of evidence and evaluate whether percutaneous transluminal angioplasty of the superficial femoral artery is a sufficient stand alone treatment in terms of clinical and technical success rates, or whether combined angioplasty and stenting demonstrates superior results. Citing a series of relevant studies, including the meta-analysis by Muradin et al and others, Lammer will compare angioplasty of the superficial femoral artery against bare metal stents.
Following the disappointing results from several studies (such as the Femoral Artery Stenting Trial [FAST]) that failed to show any clear benefit of stenting in the superficial femoral artery, two trial results will be presented in this session for the first time in Europe, in an attempt to boost the evidence for stenting.
Dr Barry Katzen from the Baptist Cardiovascular Institute, Miami, FL, will present the 12-month results from the RESILIENT trial. The RESILIENT trial is a randomised study comparing the Edwards self-expanding LifeStent vs. angioplasty-alone in lesions involving the superficial femoral artery and/or proximal popliteal artery.
In late 2006, results at six-months were reported showing that clinical success was 56.8% in the angioplasty arm and 67.4% in the stenting arm with primary patency (Duplex) 41.2% in the angioplasty arm and 89.7% in the stenting arm. Freedom from re-intervention was 56.5% in the angioplasty arm and 94.6% in the stenting arm. The number of stent fractures was four (elongated stents) from 192 implanted stents (n=120), equating to a fracture rate (per evaluable stents) of 2.2%.
Dr Michael Dake from the University of Virginia, VA, will present an update from Cook’s ZILVER PTX Drug-Eluting Stent trial. The objective of the randomised ZILVER trial is to examine the safety of using the ZILVER PTX stent to treat blockages of the superficial femoral artery. To reduce or prevent restenosis, the ZILVER PTX stent is coated with paclitaxel, and according to Cook, this is the first trial ever to investigate the safety and efficacy of paclitaxel-eluting stents in the superficial femoral artery. The data was compiled based on enrollment in the pilot portion of the clinical investigation, which began March 2005 and was completed last year.