Randomized trial of Legflow® paclitaxel eluting balloon and stenting versus standard percutaneous transluminal angioplasty and stenting for the treatment of intermediate and long lesions of the superficial femoral artery (RAPID trial): study protocol for a randomized controlled trial

Abstract

BackgroundRestenosis 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 neointimal 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, a Food and Drug Administration (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 >5 cm.Methods/DesignA total of 176 adult patients with Rutherford class 2 to class 6 symptoms due to intermediate (5–15 cm) or long (>15 cm) 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 Technologies 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 four 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 the event that DUS reveals a symptomatic >50% restenosis, or a >75% asymptomatic restenosis, additional digital subtraction angiography will be performed with any necessary re-intervention.DiscussionThe RAPID trial is a multicenter randomized controlled patient blind trial that will provide evidence concerning 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.Trial registrationISRCTN47846578

Short-term Results of the RAPID Randomized Trial of the Legflow Paclitaxel-Eluting Balloon With Supera Stenting vs Supera Stenting Alone for the Treatment of Intermediate and Long Superficial Femoral Artery Lesions

“…Each participating physician at the 8 sites (7 Dutch and 1 German) had implanted at least 10 Supera stents before the start of the RAPID trial, and all physicians performed >100 endovascular femoropopliteal interventions a year. The full study protocol, which was approved by the ethics committees of each study site, was published, 22 and the trial was registered on the Current Controlled Trials website ( controlled-trials.com ; identifier ISRCTN47846578). All study procedures were conducted in accordance with good clinical practices and applicable laws.…”

“…Other outcomes were secondary patency (patency reestablished after occlusion), freedom from clinically driven target lesion revascularization (CD-TLR), reocclusion, amputation, sustained Rutherford class improvement, and sustained ABI and toe pressure improvement. 22 Safety outcomes were freedom from death and freedom from major adverse limb events at 30 days and freedom from all-cause death at 1 year.…”

Drug-Coated Balloon and Stent Therapies for Endovascular Treatment of Atherosclerotic Superficial Femoral Artery Disease

“…At 12 months, the primary endpoint of binary restenosis was reached in 17 % DCB vs. 47 % PTA (p=0.008), and TLR in 17 % DCB vs. 33 % PTA (p = 0.07). An upcoming RCT, RAPID (Randomized Trial of Legflow Paclitaxel-Eluting Balloon and Stenting Versus Standard Percutaneous Transluminal Angioplasty and Stenting for the Treatment of Intermediate and Long Lesions of the Superficial Femoral Artery), will also compare DCB versus PTA as a pre-dilation strategy, but in intermediate (5-15 cm) and long (>15 cm) lesions more closely resembling clinical practice [32]. An ongoing RCT is comparing DCB to PTA as a post-dilation strategy following nitinol stent implantation, and 12-month interim results favor lower TLR rates with the DCB (8 % vs. 17 %; p value not reported) [33].…”

Primary Stenting in Femoropopliteal Occlusive Disease – What Is the Appropriate Role? –

“…Gore & Associates, AZ, USA) in Europe in 1996, followed by the Food and Drug Administration (FDA) approval of the use of Viabahn ® for balloon with Supera stenting in patients with atherosclerotic SFA disease. 22 …”