The LEVANT I (Lutonix Paclitaxel-Coated Balloon for the Prevention of Femoropopliteal Restenosis) Trial for Femoropopliteal Revascularization

Scheinert, Dierk; Duda, Stephan H.; Zeller, Thomas; Krankenberg, Hans; Ricke, Jens; Bosiers, Marc; Tepe, Gunnar; Naisbitt, Scott; Rosenfield, Kenneth

doi:10.1016/j.jcin.2013.05.022

Cited by 359 publications

(277 citation statements)

References 25 publications

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“…In published randomized trials of femoropopliteal disease, [7][8][9][10] DCBs were generally studied in focal or short lesions, while long, complex disease or severe calcification were excluded to prevent primary angioplasty failure and to minimize bailout stenting.…”

Section: Introductionmentioning

confidence: 99%

Six-Month Results From the Initial Randomized Study of the Ranger Paclitaxel-Coated Balloon in the Femoropopliteal Segment

et al. 2017

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, on behalf of the RANGER SFA InvestigatorsAbstract Purpose: To evaluate the performance of the Ranger paclitaxel-coated balloon vs uncoated balloon angioplasty for femoropopliteal lesions. Methods: Between January 2014 and October 2015, the prospective, randomized RANGER SFA study (ClinicalTrials.gov identifier NCT02013193) enrolled 105 patients with symptomatic lower limb ischemia (Rutherford category 2-4) and stenotic lesions in the nonstented femoropopliteal segment at 10 European centers. Seventy-one patients (mean age 68±8 years; 53 men) were enrolled in the Ranger drug-coated balloon (DCB) arm and 34 patients (mean age 67±9 years; 23 men) were assigned to the control group. Six-month analysis included angiographic late lumen loss and safety and clinical outcomes assessments. Results: Baseline characteristics of the DCB and control groups were similar, as were lesion lengths (68±46 vs 60±48 mm; p=0.731), severity of calcification (p=0.236), and the prevalence of occlusions (34% vs 34%; p>0.999). At 6 months, late lumen loss was significantly less for the DCB group vs controls (-0.16±0.99 vs 0.76±1.4; p=0.002). The DCB group had significantly greater freedom from binary restenosis (92% vs 64%; p=0.005) and primary patency rates (87% vs 60%; p=0.014). Target lesion revascularization rates were 5.6% in the DCB group and 12% in the control group (p=0.475). No target limb amputations or device-related deaths occurred in either group. Conclusion: Six-month results suggest that Ranger DCB treatment effectively inhibited restenosis in symptomatic femoropopliteal disease, resulting in improved vessel patency and a low revascularization rate in the short term compared with uncoated balloon angioplasty.

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Section: Introductionmentioning

confidence: 99%

Six-Month Results From the Initial Randomized Study of the Ranger Paclitaxel-Coated Balloon in the Femoropopliteal Segment

et al. 2017

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“…[102] More recently, the Lutonix Paclitaxel-Coated Balloon for the Prevention of Femoropopliteal Restenosis (LEVANT I) trial demonstrated significantly decreased mean late lumen loss for de novo SFA disease treated with the lower paclitaxel dose Lutonix DCB versus conventional balloons in patients treated with either angioplasty only or after stenting. [103] The Drug-Eluting Balloon in Peripheral Intervention for The Superficial Femoral Artery trial randomizing patients to upfront DCB or conventional angioplasty followed by stenting demonstrate similarly encouraging results at 12 months. [104] Most studies of infrapopliteal revascularization include more CLI than IC patients, [105,106] and IC alone is an uncommon indication.…”

Section: Current Trends and Outcomes: Endovascular Management In Artementioning

confidence: 91%

“…DCB with adjunctive atherectomy may address some issues associated with stent placement in these segments even though flow-limiting dissections, recalcitrant recoil, or residual disease would still limit this approach. [82] Intermittent Claudication (IC) represents a progression of arterial obstruction caused by obstructive PAD causing ischemia. In contrast to both CLI and ALI the timing or need for revascularization in claudication is largely dictated by lifestyle limitation.…”

Section: Figure5 An Intraoperative Photograph Of a Right Femoral To mentioning

confidence: 99%

Current Trends and outcomes: Endovascular Management in Arteriosclerosis Obliterans (ASO) of Lower Limb Vessels

2016

ARC Journal of Surgery

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“…In one clinical study of a drug-coated balloon which allowed stratification to stent treatment, primary stenting was selected over balloon-only treatment for approximately 25% of patients [40], and in a registry of patients treated with a drug-coated balloon, 23% of patients also had a stent implanted [41]. Provisional stenting rates after acute percutaneous angioplasty (PTA) failure in the aforementioned and other recent clinical trials averaged approximately 13% [34,36,38,40,42]. In a study designed to compare efficacy of balloon-based PTA with that of a drugcoated stent, 50% of those patients who had been randomly assigned to the PTA arm received provisional stents [4].…”

Section: Expert Opinionmentioning

confidence: 99%

Eluvia™ peripheral stent system for the treatment of peripheral lesions above the knee

Müller‐Hülsbeck¹

2016

Expert Opinion on Drug Delivery

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Introduction: Drug-eluting stents promise to reduce restenosis following endovascular treatment of diseased arteries, but technologies used in peripheral arteries of the leg have not yet achieved desired success rates. Areas covered: The rationale behind the development of the Eluvia TM Drug-Eluting Vascular Stent (Boston Scientific, Marlborough, MA) is described and current preclinical and clinical evidence related to use of the stent is reviewed. Expert opinion: Stents remain an important endovascular treatment option for femoropopliteal lesions, especially those that are long, occluded, and calcified. Drug-eluting stent technologies show promise to improve patency rates, potentially shifting the primary treatment preference away from balloon-based treatment. The available preclinical and clinical data on treatment with Eluvia TM suggest that prolonged paclitaxel elution in the femoropopliteal arteries prevents restenosis and may reduce the need for reintervention.

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The LEVANT I (Lutonix Paclitaxel-Coated Balloon for the Prevention of Femoropopliteal Restenosis) Trial for Femoropopliteal Revascularization

Abstract: Treatment of femoropopliteal lesions with the low-dose Lutonix DCB reduced late lumen loss with safety comparable to that of control angioplasty. (LEVANT I, The Lutonix Paclitaxel-Coated Balloon for the Prevention of Femoropopliteal Restenosis; NCT00930813)

Cited by 359 publications

References 25 publications

Six-Month Results From the Initial Randomized Study of the Ranger Paclitaxel-Coated Balloon in the Femoropopliteal Segment

Six-Month Results From the Initial Randomized Study of the Ranger Paclitaxel-Coated Balloon in the Femoropopliteal Segment

Current Trends and outcomes: Endovascular Management in Arteriosclerosis Obliterans (ASO) of Lower Limb Vessels

Eluvia™ peripheral stent system for the treatment of peripheral lesions above the knee

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