STREAMER (STentREstenosisAndMEdication Release): Failure of Local Delivery of Paclitaxel for the Prevention of Restenosis in Stenting of TASC C-D Femoropopliteal Segment - Abstract
Background and objective: Stenting of long lesions TASC C-D of the superficial femoral and/or popliteal artery (SFPA)in patients with critical limb ischemia (CLI) is associated with a restenosis rate of around 50% at one year. The aim of the present study was to evaluate feasibility and efficacy of a new local delivery of paclitaxel through a microporous PTFE balloon to prevent in-stent restenosis in these patients. Methods: Prospective, single-centre, non-randomized study included patients with CLI presenting de novo atherosclerotic lesions of the SFPA >15 cm in length, grade C or D of the TASC II classification. Paclitaxel was delivered after stent implantation, using a microporous balloon. The primary endpoint was the rate of in-stent restenosis at 12 months. Results: From December 2013 to August 2014, 15 patients were included; 9 were followed up until 1 year, of whom 8 had total thrombosis of the SFPA. Three patients dropped out of the study and 3 procedures failed. The average length of the stented segment was 352 mm. There was no delivery failure or adverse effects. During follow-up, there were 5 thromboses and 2 restenoses, leading to 2 bypasses, 3 angioplasties and one fibrinolysis, yielding a restenosis rate of 78% and a TLR rate of 67% at one year. Conclusion: Our results suggest that local delivery of paclitaxel with this method of local delivery incurred no adverse effects but is not effective in preventing restenosis of long stenting of the SPFA in patients with CLI.