Femoral artery disease: optimising endovascular treatment

This session started with a brief introduction from Professor Giancarlo Biamino that highlighted the importance of effective treatments for femoral artery disease. The treatment of long or complex superficial femoral artery (SFA) lesions, and in particular total occlusions of the SFA, is still debated by interventionalists and vascular surgeons.This kind of continuous debate is necessary, however, as to date there are no consistent results with level 1 evidence.

Evidence in superficial femoral artery stenting

There has been a tremendous rise in the use of stents in SFA in recent years and Professor Frank Vermassen asked whether this increase was justified. Evidence–based data are available from randomised studies like FAST, ABSOLUTE, and RESILIENT. These suggest that in long lesions, stenting can improve results compared with percutaneous transluminal angioplasty alone.

With regard to the potential development of dedicated drug-eluting stents (DES), as presented by Professor Biamino, data show that many questions still need to be asked, including dose, method of drug delivery, elution rates, and toxicity. Next generation DES are in development and novel methods of drug delivery (e.g. balloon coatings and microinfusion catheters) may benefit patients.

Covered stents have also proved promising and Professor Martin Schillinger discussed their use. This presentation concluded that these devices are clearly indicated in bail-out situations (e.g. rupture) when other measures fail. The potential role of these devices in obstructive atherosclerosis, in–stent restenosis and aneurysms requires further evaluation in randomised controlled studies. Dr Dierk Scheinert discussed the issue of calcified lesions, which are a well-known and underreported clinical problem that increases the risk of stent fracture. Indeed, data show that approximately 35% to 70% of all lesions are calcified (depending on the location of the lesion, the disease state and the presence of co-morbidities). He reported that interwoven self–expanding nitinol stents provide enhanced radial strength and flexibility and perform well in calcified lesions.

Dr Thomas Zeller presented data that showed studies are underway to compare various debulking concepts in specific lesion morphologies. He regarded the potential benefits as being a reduced need for stents and that diabetic patients in particular might benefit from debulking procedures. In fact Dr Zeller predicted that debulking along with local drug delivery might become the normal practice in the future. Professor Jean– Baptiste Ricco brought the meeting to a close by presenting data from the randomised BASIL trial. This demonstrates broadly similar outcomes regarding amputation- free survival between surgery and angioplasty, and as such a percutaneous approach should be considered first-line.

Patient selection is key

During the session it was also demonstrated that the use of self expandable nitinol stents in long lesions is of great value as they show better long–term results in randomised studies. It is, however, necessary in long vessels to accept restenosis rates of around 35% combined with very acceptable secondary patency rates. Indeed, long–term patency is around 85-90% and this corresponds well with published data on femoro-popliteal bypass surgery. The opinion of the presenters during this session was that stenting will probably partially replace bypass surgery although at the moment, there are no validated results from trials using DES. Initial data relating to new atherectomy or debulking techniques are very promising, but randomised controlled trials are needed. The live transmissions by Professor Horst Sievert and Dr Rob Gallino from Frankfurt, Germany showed that the treatment of very complex femoro–popliteal lesions perfectly matched with the data presented during the session. As such, the educational value of this session has to be considered very high. The take–home message is that with adequate training and skill, practically any type of lesion in the femoro–popliteal area can be passed with very acceptable initial results. However, patients need to be carefully selected to identify those that will benefit most from treatment. Finally, the treatment of SFA is still in an evolving phase.