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LEVANT I: Low-dose DCB improved late lumen loss in femoropopliteal lesions
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The Lutonix drug-coated balloon was associated with a nearly 60% lower 6-month late lumen loss when compared with uncoated balloons in a cohort of individuals with femoropopliteal lesions, concluded recent findings.
The aim of the randomized, prospective, single blind LEVANT I study was to evaluate the drug-coated balloon (DCB; Lutonix) in terms of safety and efficacy for the treatment of femoropopliteal lesions. The device is coated with 2 mcg/mm2 paclitaxel and a polysorbate/sorbitol carrier. Devices with 3 mcg/mm2 have demonstrated efficacy in restenosis in peripheral vascular disease, according to the investigators.
Eligibility criteria included Rutherford class 2 to 5 femoropopliteal lesions. Patients were accrued at nine centers between June and December 2009.
The analysis included 49 patients randomly assigned the Lutonix device and 52 patients assigned uncoated balloons. Stratification was based on whether balloon-only treatment (n=75) or stenting was intended (n=26).
Angiographic late lumen loss at 6 months served as the primary outcome measure. Adjudicated major adverse events — including death, amputation, target lesion thrombosis and reintervention — functional outcomes and pharmacokinetics were used as secondary endpoints.
The mean lesion length was 8.1 ± 3.8 cm and the total occlusion rate was 42%. Study participants were matched for demographic, peripheral vascular disease and lesion characteristics.
Six-month results indicated that late lumen loss was 0.46 ± 1.13 mm in the study group and 1.09 ± 1.07 mm in the control group (P=.016), which the investigators noted was a 58% difference.
At 24 months, patients in the Lutonix group experienced a 39% major adverse event rate that included 15 target lesion revascularizations, one amputation and four deaths. In the uncoated balloon group, 49% of patients experienced a major adverse event, with 20 TLRs, one thrombosis and five deaths.
The study device demonstrated biexponential decay with peak concentration of 59 ng/mL and total observed exposure of 73 ng h/mL, according to results of the pharmacokinetic analysis. There were eight malfunctions. Among successful DCB interventions, 6-month late lumen loss was 0.39 ± 1.11 mm. Successful deployments also yielded a 24% TLR rate at 24 months.
“Treatment of femoropopliteal lesions with the low-dose Lutonix DCB reduced late lumen loss with safety comparable to that of control angioplasty,” the investigators concluded.
Disclosure: Lutonix, a subsidiary of C. R. Bard, sponsored the trial. Researchers report financial disclosures with companies including Abbott Vascular, Angioslide, Biotronik, Boston Scientific, Cook, Covidien-ev3, C.R. Bard, InnoRa, Johnson & Johnson, Krauth Medical, Lutonix, Medtronic, Straub Medical and W.L. Gore. See the study for the full list of disclosures.
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