Paclitaxel-Releasing Balloon in Femoropopliteal Lesions Using a BTHC Excipient: Twelve-Month Results From the BIOLUX P-I Randomized Trial. (February 2015)

• Record Type: Journal Article
• Authors: Scheinert, Dierk; Schulte, Karl-Ludwig; Zeller, Thomas; Lammer, Johannes; Tepe, Gunnar
• Is Part Of: Journal of endovascular therapy. Volume 22:Number 1(2015:Feb.)
• Page Start: 14
• Page End: 21
• Publication Date: 2015-02
• Subjects: peripheral artery disease -- stenosis -- occlusion -- femoropopliteal lesions -- paclitaxel-coated balloon -- drug-eluting balloon -- drug-coated balloon -- drug-releasing balloon -- balloon angioplasty -- restenosis -- BTHC -- superficial femoral artery -- popliteal artery; Blood-vessels -- Endoscopic surgery -- Periodicals; Angioscopy -- Periodicals; Intravenous catheterization -- Periodicals; Peripheral vascular diseases -- Treatment -- Periodicals; Vascular Surgical Procedures -- Periodicals; Angioscopy -- Periodicals; Catheterization, Peripheral -- Periodicals; Peripheral Vascular Diseases -- therapy -- Periodicals; Angioscopie; Maladies vasculaires périphériques; 617.413
• DOI: 10.1177/1526602814564383
• Languages: English
• ISSNs: 1526-6028

Abstract

Purpose: To evaluate the safety and efficacy of the novel Passeo-18 Lux paclitaxel-coated balloon compared with the Passeo-18 uncoated balloon in patients with symptomatic de novo or restenotic femoropopliteal lesions.Methods: Sixty patients (34 men; mean age 70.7±10.1 years) in 5 European centers were enrolled in the BIOLUX P-I trial ( ClinicalTrials.gov identifier NCT01056120) and randomized 1:1 to either the paclitaxel-coated balloon or the uncoated balloon. The primary endpoint was late lumen loss at 6 months. Secondary endpoints were binary restenosis at 6 months, clinically driven target lesion revascularization (TLR), change in ankle-brachial index and Rutherford classification, and major adverse events at 6 and 12 months.Results: At 6 months, patients treated with paclitaxel-coated balloons had a significantly lower late lumen loss (0.51±0.72 vs. 1.04±1.00 mm, p=0.033) and binary restenosis (11.5% vs. 34.6%, p=0.048) than the control group. Correspondingly, clinically driven TLR was lower in the paclitaxel-coated balloon group at 12 months [15.4% vs. 41.7% (p=0.064) for the intention-to-treat population and 16.0% vs. 52.9%, (p=0.020) for the as-treated population]. No death and one minor amputation were observed compared with two deaths and two minor amputations in the control group. No major amputations or thrombosis were reported.Conclusion: The Passeo-18 Lux paclitaxel-coated balloon has been proven to be safe and effective in patients with femoropopliteal lesions, with superior performance outcomes compared with treatment with an uncoated balloon.