Selected article for: "major group and minor group"

Author: Scheinert, Dierk; Schulte, Karl-Ludwig; Zeller, Thomas; Lammer, Johannes; Tepe, Gunnar
Title: Paclitaxel-releasing balloon in femoropopliteal lesions using a BTHC excipient: twelve-month results from the BIOLUX P-I randomized trial.
  • Cord-id: wpd34ai3
  • Document date: 2015_1_1
  • ID: wpd34ai3
    Snippet: 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 lum
    Document: 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.

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