Stenting of long femoro-popliteal lesions (TASC C and D): A pilot study on the feasibility of the local delivery of paclitaxel and its effectiveness to prevent restenosis streamer (stent restenosis and medicaments release)

Objectives: The stenting of the long lesions of the superficial femoral and/or the popliteal arteries (TASC C and D) in patients with critical ischemia is followed by a rate of restenosis around 50% at one year. Active stents did not show their effectiveness for these lesions. Active balloons pose the problem of their cost, toxicity and the absence of authorization to treat very long lesions. The aim of our study was to evaluate the feasibility and the effectiveness of the local delivery of paclitaxel by a microporous PTFE balloon to prevent intra-stent restenosis in patients with critical ischemia presenting TASC C and D femoro-popliteal lesions before the application for a multicenter trial. Materials and Methods: This was a pilot monocentric, prospective, non-randomized protocol conducted in an academic hospital, declared and controlled by the National Agency for the Security of Drugs (ANSM), including the patients with critical ischemia and de novo femoro-popliteal TASC C and D atheromatous lesions longer than 15 cm. The paclitaxel solution, prepared in the pharmacy, was delivered after stenting, through the microporous balloon. The blood level of paclitaxel was determined after two minutes and 24 hours. The principal criterion of judgment of this pilot study was the number of patients likely to be included and the number really included. The secondary criteria of judgment were the occurrence of side effects of the antimitotic drug, the proportion of intrastent restenosis, the TLR and the rate of limb salvage at 1, 6 and 12 months. Results: Between December 2013 and August 2014, 12 patients, 11 thromboses and one stenosis were included. The average length of stents was 352 mm. Nine patients received paclitaxel (three failures of recanalization), with an average dose of 21.9 mg, and without delivery problem or side effect. There were five thromboses and two restenoses during the followup, leading to two bypasses, three angioplasties and one fibrinolysis. The rate of restenosis was 78% and TLR was 67% at one year. One patient was not reoperated. Complete wound healing was obtained in three patients. The rate of limb salvage was 100% at one year. Conclusion: Our results suggest the absence of effectiveness of this technique to prevent restenosis in case of long femoro-popliteal stenting. The protocol is feasible but its results show the need for too many patients to conduct a study. This pilot study does not suggest carrying out this research. A pilot study is really necessary before conducting a multicenter study.