Randomized trial of Legflow® Paclitaxel eluting balloon (LPEB) and stenting vs. standard PTA and stenting for the treatment of intermediate (>5 cm and < 15 cm) and long (>15 cm) lesions of the superficial femoral artery. The RAPID trial.
A. Karimi1, S. de Boer2, D. Werson1, D.A.F. van den Heuvel2, B. Fioole3, J.A. Vos2, J.P.P.M. De Vries1
1. Department of Vascular Surgery, St. Antonius Hospital, Nieuwegein, The Netherlands.
2. Department of Interventional Radiology, St. Antonius Hospital, Nieuwegein, The Netherlands.
3. Department of Vascular Surgery, Maasstad Hospital, Rotterdam, The Netherlands
Restenosis after percutaneous transluminal angioplasty (PTA) of the superficial femoral artery (SFA) may occur in 45% of patients at 2 years follow-up. Paclitaxel coated balloons have been found to reduce neo-intimal hyperplasia, and thus reduce restenosis. Recently, the Legflow® Paclitaxel coated balloon (Cardionovum Sp.z.o.o., Warsaw, Poland) (LPEB) has been introduced. This balloon is covered with Shellac, an FDA approved natural resin, to obtain an equally distributed tissue concentration of Paclitaxel. The RAPID trial is designed to assess restenosis after PTA using the Legflow balloon combined with Nitinol stenting versus uncoated balloons with Nitinol stenting in SFA lesions >5cm. In this study 176 adult patients with Rutherford class 2-6 symptoms due to intermediate (5-15 cm) or long (>15cm) atherosclerotic lesions in the SFA will be randomly allocated for treatment with LPEB with Nitinol stenting or uncoated balloon angioplasty with stenting. Stenting will be performed using the Supera® stent in both groups (IDEV inc., Webster TX). The primary endpoint is the absence of binary restenosis of the treated SFA segment. Secondary outcomes are target lesion revascularization (TLR), clinical and hemodynamic outcome, amputation rate, mortality rate, adverse events, and device specific adverse events. Follow up consists of 4 visits in which ankle-brachial indices (ABI), toe pressure measurements, and duplex ultrasound (DUS) will be performed. Furthermore, a peripheral artery questionnaire (PAQ) will be completed by the patients at each follow-up. In case DUS reveals a symptomatic >50% restenosis, or a >75% asymptomatic restenosis additional digital subtraction angiography will be performed with any necessary reintervention. The RAPID trial is a multi-centre randomized controlled patient blind trial that will provide evidence whether the use of the Legflow Paclitaxel/Shellac coated balloons with Nitinol stenting significantly reduces the frequency of restenosis in intermediate and long SFA lesions compared to standard PTA and stenting.