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J Endovasc Ther. 2015 Feb;22(1):14-21. doi: 10.1177/1526602814564383.

Paclitaxel-releasing balloon in femoropopliteal lesions using a BTHC excipient: twelve-month results from the BIOLUX P-I randomized trial.

Author information

1
Park Hospital and Universitätsklinikum Leipzig, Germany dierk.scheinert@medizin-uni-leipzig.de.
2
Ev. Krankenhaus Königin Elisabeth Herzberge, Berlin, Germany.
3
Universitaets-Herzzentrum Freiburg-Bad Krozingen, Germany.
4
Medical University of Vienna, Austria.
5
Rosenheim Hospital, Rosenheim, Germany.

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.

KEYWORDS:

BTHC; balloon angioplasty; drug-coated balloon; drug-eluting balloon; drug-releasing balloon; femoropopliteal lesions; occlusion; paclitaxel-coated balloon; peripheral artery disease; popliteal artery; restenosis; stenosis; superficial femoral artery

PMID:
25775674
DOI:
10.1177/1526602814564383
[Indexed for MEDLINE]

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