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Gargiulo M., Bianchini Massoni C., Abualhin M., Freyrie A., Faggioli G. L., Stella A.
Unit of Vascular Surgery, Department of Experimental, Diagnostic and Speciality Medicine, University of Bologna, Policlinico Sant’Orsola‑Malpighi, Bologna, Italy
Restenosis remains a major drawback of the endovascular treatment of femoro-popliteal arterial steno-obstructive disease. Although the use of the stent, in particular the drug eluting stent with paclitaxel, has modified the incidence of this late complication, in clinical practice the indication for femoro-popliteal stenting is limited to post-angioplasty flow-limiting dissection, recoil and wall thrombosis. As the current concept for the prevention of restenosis after angioplasty include the use of antiproliferative drug leaving nothing inside the artery, the drug eluting balloon seem to be a promising tool to decrease the risk of this complications. The results of In.Pact SFA Trial presented at the Charing Cross Meeting in London in April 2014 are in line with this hypothesis. The purpose of this article is to report the rationale of paclitaxel-coated balloon in the prevention of restenosis, the most recent trials/registry investigating the clinical effectiveness of paclitaxel-coated balloon for treatment superficial femoral artery obstructive disease and the results of the In.Pact SFA trial.