Drug eluting balloons in femoro-popliteal artery disease

Abstract

Treatment of femoropopliteal artery disease by percutaneous transluminal angioplasty (PTA) is limited by high rates of restenosis (40% to 60%) 6 to 12 months after procedure. The high mechanical stress (bending, compression, torsion) that occurs in the femoropopliteal arteries with normal patient movement is associated with an increased risk for stent fractures and in-stent restenosis. Furthermore, the reduction of restenosis seen with drug-eluting stent treatment of coronary artery disease was not observed in several studies of drug-eluting stent use in femoropopliteal artery disease. Hence, an alternative stent-free therapy that may similarly reduce restenosis and improve clinical outcome has been sought. To review the recent clinical trials using drug-eluting balloons (DEB) in treatment of femoropopliteal artery disease. There are four already finished randomized studies in patients with superficial femoral artery lesions investigating the efficacy of paclitaxel release by DEB. Currently there is a rapidly increasing clinical study program using DEB in different locations and indications. All 4 trials demonstrated significantly improved patency rates at 12 and 24 months angiographic follow-up compared to standard PTA. DEB offer several advantages compared to drug eluting stents, since any stentless technology for improving long-term patency is preferable to overcome the drawbacks of stenting in this mobile segment. DEB technology has demonstrated the capacity to have a significant impact on the practice of percutaneous cardiovascular interventions in the future. Several clinical trials have demonstrated promising early and mid-term results in treating femoropopliteal lesions. Long-term results, exact indications, and optimal applications are yet to be determined.