Femoropopliteal In-stent Restenosis Repair: Midterm Outcomes After Paclitaxel Eluting Balloon Use (PLAISIR Trial) (original) (raw)

2017, European journal of vascular and endovascular surgery : the official journal of the European Society for Vascular Surgery

The aim was to assess 18 month outcomes of the paclitaxel eluting balloon (PEB) in patients with femoropopliteal (FP) in-stent restenosis (ISR). In a national prospective and multicentre cohort study, symptomatic patients with femoropopliteal in-stent restenosis were included from January 2012 to June 2013. Patients were treated by paclitaxel eluting balloon angioplasty (In Pact Admiral, Medtronic, Santa Rosa, CA, USA). Clinical and duplex scan follow-up evaluations were performed at 1, 3, 6, 9, 12, and 18 months. The primary endpoint was freedom from target lesion revascularisation (TLR) at 12 months. Secondary endpoints were major adverse cardiovascular events (MACE), Target extremity revascularisation (TER), primary and secondary sustained clinical improvement, recurrent restenosis rate, primary and secondary patency, quality of life assessed by EQ-5D questionnaire, technical success, clinical success, and length of stay RESULTS: A total of 53 patients were enrolled. After a blin...